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Estudio XL HAIR - Alopecia Areata

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AESTHETIC DERMAL | Research & Publications

HAIR RESTORATION
2014/2015 | Special edition

In this publication you cand find

CLINICAL STUDY
New aspects of the treatment of
ALOPECIA AREATA
XL Hair
A new medical approach for alopecia areata

Frequent

Q&A
Enjoy healthy hair!
AESTHETIC DERMAL | Research & Publications

OUR NEW PROJECT


BEST COMPLEMENTS FOR PROFESSIONAL TREATMENT WITH
XL HAIR REPARESTIM HAIR AD DAILY CARE HAIR

N-Acetyl Cysteine 280,5 mg


Vit. B6 0,85 mg
Picolinate de Zinc 4,87 mg
Stearate 85,36 mg
Folic Acid 0,24 mg
Arginine 24,39 mg
Biotin 0,18 mg
Proline 1,95 mg
Nicotinamide 8,84 mg

Coming Soon

2 | XL HAIR
AESTHETIC DERMAL | INDEX

04 CLINICAL STUDY
Research & Publications
To evaluate the efficacy of a combined treatment with xl hair in different baldness patterns

12 CASE REPORTS
Research & Publications
To evaluate the efficacy of a combined treatment with xl hair in different baldness patterns

14 CLINICAL STUDY
Clinical study to evaluate the efficacy of a combined treatment
Microneedling device, xl hair, ad daily care hair, in different baldness patterns.

16 XL HAIR
What is it
How to inject

17 BEFORE & AFTER PICTURES


Clinical study to evaluate the efficacy of a combined treatment
Microneedling device, xl hair, ad daily care hair, in different baldness patterns.

18 IN VITRO STUDY
Increased cell proliferation of human hair papillae cells increased by 23,3% after 48h
exposure to XL Hair

19 New aspects of the treatment of


ALOPECIA AREATA

24 FOCUS ON HAIR COLORING


& SCALP PROBLEMS
XL Hair, Reparestim TD Hair, AD Daily care Hair

25
XL HAIR
A new medical approach for
ALOPECIA AREATA

28 REPARESTIM HAIR TD - AD DAILY CARE


New approach in hair loss treatment
Optimally prepare the skin before hair transplantation

30 FREQUENT Q&A
Questions & Answers
About XL Hair, Reparestim Hair TD & AD Daily care

INDEX | 3
AESTHETIC DERMAL | Research & Publications

CLINICAL STUDY
TO EVALUATE THE EFFICACY OF A COMBINED
TREATMENT WITH XL HAIR IN DIFFERENT
BALDNESS PATTERNS
by Evgeniya Ranneva, phd, dermatologist (Spain) and Gabriel Siquier, aesthetic medicine practicioner (Netherlands)

The type of hair loss known in androgen-mediated disorder that


dermatology as alopecia has been a causes hair thinning in a defined
problem throughout human history, pattern. In the hair follicle cells,
regardless of gender or age. Hair testosterone converts into the
loss could be the symptom of a the biologically more active metabolite
skin disease or a complementary dihydrotestosterone (DHT) catalysed
symptom of other internal illness. by the enzyme 5-alpha reductase.
Hair loss is very visible and a This hormone binds to androgenic
blurred line between health and receptors in the hair follicle and
illness. the specific bond
It is a well- triggers cellular pict 1. Female pattern hair loss (FPHL)
known fact processes which
that female reduce the anagen
(picture 1) and phase of the hair
male (picture 2) pattern hair loss are cycle. For this reason the hair
different in their etiological and passes earlier into the telogen
physiological processes, except phase and falls out. Gradually,
in regards to the androgenic factor, over succeeding cycles, large,
clinical symptoms, and progression thick, pigmented terminal hair
of symptoms. We specially avoid converts into thinner, shorter,
using the words illness or disease, indeterminate hairs and finally to
because, often, hair loss is a short, wispy, non-pigmented vellus
condition of the persons general hair (i.e. the retrograde phase pict 2. Male pattern hair loss (MPHL)
appearance. On the other hand, of the cycle) and the hair follicle
such conditions could develop into becomes minute ( picture 3 ). The
an illness easily and suddenly, a fact density of the androgenic receptors
that may instigate impressive and in the hair follicles varies according
dramatic changes in psychological to location in a manner that is
status of the people. Based on the genetically determined. However, the
scientific research available for pathogenetic mechanisms underlying
our analyses we could present the AGA are not fully understood.
common view on the classification Age factors too play an important
of hair loss. Different classification role in AGA. The first manifestation pict 3. Hair follicle cycle
forms of alopecia (hair loss) are usually occurs in the third decade.
reported in the literature, most of The prevalence of AGA increases The hormone
them are based on androgenic and with ageing, from 31% at age testosterone plays
non-androgenic types. Testosterone 4055 years to 53% at age 6569
an important
activity is the most known and years .
well-studied etiopathology of hair Female pattern hair loss (FPHL),
role, seemingly
loss. The hormone testosterone or female patterned alopecia, is a independent of genetic
plays an important role, seemingly form of non-scarring alopecia that predisposition.
independent of genetic predisposition. might also be linked with androgen
Androgenic alopecia (AGA) is an dysfunction. Androgenic alopecia

4 | XL HAIR
AESTHETIC DERMAL | Research & Publications

in women is less frequent, though the etiology


is in principle the same as in men. Who is suffering
The actual statistic of female pattern hair loss
(FPHL) does not reflect the actual state of the
problem, as complaints of hair loss or thinning
more?
hair are not a priority for the patients compared Despite a significantly large prevalence, many
to other diseases detected at the same time. women feel the condition is rare and are affected
Diffuse, rapid onset, non-scarring alopecia socially and psychologically.
is not common in patterned alopecia and Relative to control subjects, women with
should raise suspicion to the existence of iron FPHL completing a standardized questionnaire
deficiency, thyroid disease or other endocrine possessed a more negative body image and
disorders such as polycystic ovarian syndrome, a pattern of less adaptive functioning. FPHL
medication exposure; or an autoimmune etiology. is solely a cosmetic concern which fosters
The relationship of FPHL with pregnancy and psychological distress for patients, as it has a
maternity is by now widely known. notable impact on quality of life; thus, women
FPHL that occurs commonly in postmenopausal seeking evaluation want successful treatments
adult women is characterized by a progressive that can minimize further hair loss while also
reduction in hair density on the crown of the stimulating new hair growth or regrowth of
scalp with sparing of the frontal hairline (Ludwig previously lost hairs.
scale). Temporal recession occurs to a lesser
degree in females compared to than in males.
After extensive research on PubMed, we were
surprised not to find any information about the
Therapy
Unfortunately, no current therapy is curative
aging process of hair, which can be explained as and only one FDA-approved treatment is
genetically determined shortening of the anagen available at this time. Heightened interest and
phase of growth with a constant telogen phase demand for improved, successful treatments
leading to a gradual conversion of terminal hairs have stimulated an expansion of treatments.
into vellus hairs. When presenting the existing treatments we
specify: pharmacological activity (PhA), legal

What is the clinical status (LS) of pharmacological substances, well


known commercial name (CN) of the product(s),

difference? negative information & side effects (NISE).

Minoxidil - vasodilator through the stimulation


The FPHL pattern varies among individuals. The of potassium channels (PhA), medication (LS),
majority demonstrate mid-frontal thinning, while approved FDA.
others have temporal and/or vertex involvement Topical minoxidil 2% (Rogaine, Johnson and
(the male type). Although uncommon in FPHL Johnson, New Brunswick, NJ, USA) (CN)
as compared to male pattern (MPHL), temporal Clinical effects are unpredictable. Facial
thinning can be present and may be a first hypertrichosis (picture 4), allergy contact dermatitis
(picture 5) (NISE)
manifestation.
In MPHL symmetric fronto-parietal retraction
Finasteride - specific inhibitor of type II 5-
of the hairline usually occurs. The hair in the
reductase (PhA).
central part of the vertex is rarefied and thin. The Finasteride 1 mg daily dose (Propecia, Merck
alopecia progresses and sooner or later results and Co, Inc, White House Station, NJ, USA) (CN)
in a bald spot on the vertex. The remaining hair is MPHL: Erectile dysfunction (NISE)
distributed in crown-like pattern above the ears FPHL: Off-label treatment (LS)
and at the scruff of the neck. However, it also
becomes gradually thinner and silky, and grows Dutasteride - inhibitor of both types I and II 5-
more slowly. reductase (PhA).
Dutasteride (Avodart, GlaxoSmithKline,
Research Triangle Park, NC, USA) (CN)
MPHL: Erectile dysfunction (NISE)

CLINICAL STUDY | 5
AESTHETIC DERMAL | Research & Publications

FPHL: Off-label treatment (LS), *Bimatoprost (Latisse, AllerganInc)


teratogenicity (NISE) is the only FDA-approved topical
treatment for hypotrichosis of the
Spironolactone reduces adrenal eyelashes.
androgen production and exerts
competitive blockade on androgen Ketoconazole - imidazole antifungal
receptors in target tissues (PhA). agent with anti-inflammatory
Spironolactone (Aldactone, Pfizer effects, antiandrogen effects,
Inc, New York, NY, USA) (CN) inhibits steroid biosynthesis of
testicular and adrenal androgens pict 4. Facial hypertrichosis by
(PhA). resource google.com
Unfortunately, no current
Off-label treatment for both
therapy is curative and
genders, except direct relation with
only one FDA-approved treatment
seborrhea (LS)
is available at this time.
Estrogens decrease the duration of
MPHL: Erectile dysfunction the telogen phase and increase the
(NISE) duration of the anagen phase in the
FPHL: Teratogenicity, menstrual human scalp (PhA). pict 5. Allergy contact dermatitis
irregularities. (NISE) FPLH: the estrogen receptor beta
Side effects of spironolactone and the polymorphism in the gene
are dose-dependent, primarily encoding aromatase (CYP19A1) in
resulting from aldosterone effects hair suggest estrogens influence on
on the renal system, and include the hair follicle growth cycles (PhA)
hypotension, hyperkalemia, fatigue, Europe : topical estrogens are
headache, weight loss, increased available for FPHL treatment (LS)
urinary frequency, and dry skin.
(NISE) Hair transplant surgery
Off-label for both genders (LS) Surgical treatment of alopecia has
pict 6. Side effect after hair
been successfully performed for the
Cyproterone acetate - synthetic past 4 decades (LS).
transplant surgery
steroid with antiandrogen and The main problem is covering the
antigonadotropic properties with bald area with donor plugs (or follicles)
weak progesterone activity (PhA). sufficient in number to be effective
Androcur ( Schering GmbH (NISE) Micro-grafting produces a
und Co. Produktions KG, Weimar, more natural appearance than the old
Germany) (CN) technique of transplanting plugs.
Weight gain, menstrual Scalp reduction has been attempted
irregularities, decreased libido, to decrease the size of the scalp to be pict 7. Folliculitis after hair
breast tenderness, feminization of a covered by transplanted hair. transplant surgery
male fetus (NISE) Transplantation procedures are
Off-label treatment for both often time consuming, uncomfortable, Side effects after hair
genders (LS) and expensive, and may not give an transplant surgery
ultimate cure even after multiple
Prostaglandin analogs (PGAs)- treatments (NISE) (Table1) (pictures 6/7) Scars
induction of the anagen phase
in telogen hair follicles through
Skin infection
Micropigmentation - pigment Folliculitis
targeting the dermal papilla (PhA). implantation into the area of hair
Latanoprost (Xalatan, Pfizer Swelling/edema
loss with decorative & camouflage Post treatment pain
Inc), Travoprost (Travatan, Alcon functions (picture 8). Micro
Laborato-ries Inc, Fort Worth, TX, Headache
pigmentation is not a medical
USA) (CN) Irregular or uneven or
procedure (LS)
Folliculitis, erythema, and delayed hair growth
Infection, folliculitis, and
burning sensation (NISE) Bleeding
allergic dermatitis (NISE)
Off-label treatment for both Numbness of the scalp
genders (LS)
Table 1. Side effect after hair transplant surgery

6 | XL HAIR
AESTHETIC DERMAL | Research & Publications

with active biorevitalization solution and


Hair loss is a cosmetically
helps to improveing the transport function of
and psychologically the actives from BS. The complex actives of
distressing problem BS are: growth factors GF (Rh-Polipeptide-
1,Copper peptide),deoxyribonucleic acid,
It is important to diagnose early and start amino acids (Alanine, Folic Acid, Leucine,
Valine,Tyrosine ,Glycine, Histidine, Isoleucine,
Lysine, Methionine, Phenylalanine, Proline,
Serine, Threonine and etc),trace elements (Ca,
Fe, K, Mg, Mn, Na, P, Se and etc),vitamins (Vit
A,PP, B,H and etc),terpenes (Quercetin),fatty
acids (Oleic Acid ,Linoleic Acid), flavonoids
(Rutin, Kaempferol), antioxidants (Quercetin,
Citric Acid, Ginkgolides A- B- C- M), NAD,
NADP. The final target of the actives is to repair
and to stimulate hair growth, increase the
treatment immediately. It has always problematic thickness of hair by improving skin nutrition
deciding who is to treat patients experiencing hair and skin defence against internal & external
loss, especially because a lot of cases are due to stress and damage factors. Fibroblast growth
hormonal dysfunction falling under the purview factors (FGFs) and their receptors control a
of gynecologists, urologists, endocrinologists, wide range of biological functions, regulating
and dermatologists. Although few medications cellular proliferation, survival, migration and
are currently approved for the medical treatment differentiation. Added to this is the delivery of
of both genders, there are not many other options copper peptide to the base of follicles, which
that can be utilized with relatively minimal side helps strengthen hair while stimulating hair
effects. follicles to produce a strong hair shaft, help
blood circulation in the scalp, and revitalize hair
New medical
approach
One of the new potential treatments for hair
loss (androgenic and non-androgenic) is to use
medical devices CE class III for injections into
the scalp area or applying it using microneedling
devices. The main medical proposal for the new
therapeutic approach is to be safe, minimize
side effects during long-term therapy, and be
effective.
XL Hair is a new opportunity for the treatment
of different baldness patterns and symptomatic
hair loss made in conformity with EU Regulation follicles. Another group known as nutritional
(picture 9 ). The product is tested as being supplementation including vitamins, minerals,
implantable, non-allergenic, non-teratogenic, and/or antioxidants may help in hair growth and
non-cytotoxic, non-carcinogenic. health. Vitamins are necessary components and
XL Hair formula, designed for superficial play important roles in cellular metabolism.
and deep dermal injections, are based on Vitamins are considered micronutrients and
the purest and most effective ingredients, occur in only very small amounts within cells,
with synergetic actions. Non cross-linked HA but are critically important as coenzymes.
from biotechnological non-animal origin Amino acids have several functions: the energy
provides: antioxidant effect, turnover storage function (proteins can be degraded into
stimulation & matrix reorganization. acetyl-CoA and cycle the Krebs cycle) , the
Hyaluronic acid is associated in XL Hair endocrine integration function (hormones), the

CLINICAL STUDY | 7
AESTHETIC DERMAL | Research & Publications

informative function (membrane as well as a comprehensive physical


receptors, intracellular signals) examination with appropriate testing.
Trace elements ( XL Hair content: Hamilton referred to the mutual
Ca, Fe, K, Mg, Mn, Na, P, Se and etc) interplay of androgens, genetic
have an influence on the binding, and age factors in the origin of AGA
transport and release of oxygen, and elaborated a precise method
donate or accept electrons in for the clinical assessment of
reaction of reduction or oxidation, alopecia. Hamiltons classification
compensate cells nutrition and play was later modified by Norwood and
the structural role to important was used during the examination.
biological molecules. The biggest The pull test and non-invasive
group of bioreviatlization solution method of microscopic hair
of XL Hair is antioxidants. The examination on portable video
mechanisms by which these system (Menard) was included
antioxidants act at the molecular and in the study. Exclusion criteria
cellular level include roles in gene included history of severe allergic
expression and regulation, apoptosis, disorders, cutaneous infection or
and signal transduction. Antioxidants skin alteration affecting the scalp,
are involved in fundamental metabolic known hypersensitivity or allergy,
and homeostatic processes and help history of autoimmune disease,
repairing damaged biomolecules and cortical or immunosuppressant
defence antioxidant enzymes, which therapy, acute joint rheumatics,
are mostly intracellular. Thanks to repetitive angina, endocarditis, use pict 10/11 XL Hair treatment result
their unique formula, the products of anticoagulant therapy, cicatricial before & after, front side.
XL Hair & Reparestim Hair & alopecia, pregnancy and lactation.
AD daily care Hair are capillary The patients signed consent forms
regenerators which revitalize and and authorized the use of before
strengthen capillary fiber via a greater and after pictures.
contribution of essential nutrients for XL Hair (Aesthetic Dermal,
capillary growth and a stimulating Spain) injectable CE class III
action of hair growth factors. The medical device for scalp area, 3 ml
topical (Reparestim Hair ) and per vial, single use; Reparestim
daily care (AD daily care Hair) are Hair (Aesthetic Dermal, Spain) 3ml
analogs (similarly formulated) of sterile solution for topical aplication
by using sterile microneedling
injectable XL Hair, recommended
medical device Class IIa AD Roll
for use as complementary products
for the treatment of hair loss. TD + Stamp (Aesthetic Dermal,
Spain) 0,5 mm, 600 needles by roll,
12 needles by stamp, single use;

Clinical study and AD Daily Care Hair (Aesthetic


Dermal, Spain) solution 100 ml for
personal use.
XL Hair injections and
A multi-center, open label,
Reparestim Hair application with
non-comparative pilot study was
microneedling device AD Roll TD
performed in medical clinics in Spain,
+ Stamp repeated once a week
the Netherlands, and Romania , with
on the area of hair loss, total 8
47 patients (32 women and 15 men)
sessions (8 weeks) Spray AD Daily
who had sought medical attention for
hair loss. The diagnosis of alopecia Care Hair recommended for
is a combination of a detailed inquiry use directly onto the scalp and pict 12/13 XL Hair treatment result
into the patients history, including with light massage ensuring the before & after, front side.
family, social, and medical histories, product is well distributed over the
problematic area. Spray applied

8 | XL HAIR
AESTHETIC DERMAL | Research & Publications

twice a day, 3 times a week, during women more than 2 years. 60 %


minimum 12 to 24 weeks. Efficacy of womens group had a special
was determined at the 3rd and 6th diet or a nutritional deficit during 6
months. Possible side effects were months/one year.
assessed as well. In both groups 0% of patients had
Patients and physicians rated contact with any known toxin or
their satisfaction with the results radiation.
of the procedure at the end of More than 10% from both groups
the treatment on a 4-point scale had attacks of seborrhoeic
(1=non satisfactory, 2=satisfactory, dermatitis more than once, but only
3=good, 4=excellent). 5 % confirmed the diagnosis by
dermatological consultation.

Results
All patients concluded the study.
In the female group, aesthetic
improvement was significant,
starting at 8 to 12 weeks if
During clinical study we enrolled compared to before the treatment
47 patients (32 women and 15 men), (pictures 10/11) At 12 weeks 61% of
35-50 years old, who required hair female group stopped losing hair.
loss treatment targeting moderate- New hair growth was significantly
to-severe non-cicatricial alopecia increased within 24 weeks in 73%
affecting different areas, i.e. vertex, of the female group (picture 12/13).
frontal and temporal. Inclusion In the male group 41% stopped
criteria for the study were clinical active hair loss in 12 weeks.
evidence of moderate-to-severe New hair growth was significantly
pict 14/15 XL Hair treatment result non-cicatricial alopecia rated for increased in 24 weeks in 63%
before & after, front side. men as grade IIa to V using the of the male group (pictures
Norwood-Hamilton classification 14/15/16/17/18/19/20/21)
and rated for women as grade I to 60 % of both groups achieved a
III using the Ludwig classification. high rate mark of satisfaction, from
Duration of progressive hair loss good to excellent. Surprisingly,
was from 5 to 10 years. 50% of more than 85% (only 61% of them
the patients previously received achieved good clinical results) of
different treatments, including 2% the male group declarated to be
Minoxidil (Rogaine), Finasteride, highly satisfied by the treatment
nutrition supplements or other included injections technique and
daily care without satisfactory daily care application, and are
results. motivated to continue or repeat
After analyses of the anamnestic the treatment course.
data, the results are as follows:
more than 50 % of the patients have SIDE EFFECTS
genetically related hair problems ,
32 % of the patients claim about Some patients presented untoward
a stressful life, 16% related the effects like swelling and ecchymosis
problem to pregnancy and 10 % that resolved within 24 and 48 hours.
were postmenopausal hair loss,
one patient has hypertension.
30 % of the patients from the
womens group have anemia of
Conclusion
varying grades. 50 % of the patients
from the womens group are The results of the study indicate

pict 16/17 XL Hair treatment result using and hormonal contraception that injections of XL Hair and

before & after, back side. for more than 6 months, 40% of Reparestim Hair TD applied with

CLINICAL STUDY | 9
AESTHETIC DERMAL | Research & Publications

a microneedling device (AD Roll than 6 months in duration, which


TD + Stamp) and combined with means regular home daily care
AD Daily Care Hair are an efficient is very important for maintaining
treatment for hair loss in different results. The best efficacy was
baldness patterns. The results observed in case of symptomatic
indicate that intradermal injections hair loss in female pattern: after
of XL Hair and microneedling with pregnancy, nursing period, stress,
Reparestim Hair TD combined or died. In the male pattern, which
is related to androgenic alopecia,
with AD Daily Care Hair induce the
results are satisfactory but require
activation of the hair follicle which
further investigation. Patient with
promotes en enlargement of the
androgenic alopecia should be
anagen phase and a shortening
treated longer: once every one to
of the telogen phase, reversing
two weeks for a 12 weeks duration,
the miniaturization of the hair
at minimum. 60% of the patients
follicles, stopping hair loss and
from both groups were satisfied
promoting new hair growth.
with the results after 24 weeks
The protocol of application and
of treatment. The biological and
frequency of treatment have been
pharmacological functions of XL
adapted by gender. To optimize
results, the application of AD HAIR (Reparestim Hair) have not
yet been fully investigated.
Daily Care Hair cannot be less

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10 | XL HAIR
AESTHETIC DERMAL | Research & Publications

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34. Rajput RJ. Controversy: is there a role for adjuvants in the man-agement of male pattern hair loss? J Cutan Aesthet Surg. 2010;3(2): 8286.)
35. Rogers NE, Avram MR. Medical treatments for male and female pattern hair loss. J Am Acad Dermatol. 2008;59(4):547566.
36. Sawaya ME, Price VH. Different levels of 5alpha-reductase type I and II, aromatase, and androgen receptor in hair follicles of women and men with
androgenetic alopecia. J Invest Dermatol. 1997;109(3): 296300.
37. Sinclair RD, Dawber RP. Androgenetic alopecia in men and women. Clin Dermatol. 2001;19(2):167178.
38. Sinclair R, Wewerinke M, Jolley D. Treatment of female pattern hair loss with oral antiandrogens. Br J Dermatol. 2005;152(3):466473.
39. Scheinfeld N. A review of hormonal therapy for female pattern (androgenic) alopecia. Dermatol Online J. 2008;14(3):1.
40. Shamsaldeen OS, Mubki TA, Shapiro J. Topical agents for hair growth promotion: what is out there? Skin Therapy Lett. 2013 Jun;18(4):5-7.
41. Unger WP, Unger RH. Hair transplanting: an important but often forgotten treatment for female pattern hair loss. J Am Acad Dermatol. 2003;49(5):853
860
42. Whiting DA, Waldstreicher J, Sanchez M, Kaufman KD. Measuring reversal of hair miniaturization in androgenetic alopecia by follicular counts in
horizontal sections of serial scalp biopsies: results of finasteride 1 mg treatment of men and postmenopausal women. J Investig Dermatol Symp Proc.
1999;4(3):282284.
43. Yip L, Rufaut N, Sinclair R. Role of genetics and sex steroid hormones in male androgenetic alopecia and female pattern hair loss: an update of what
we now know. Australas J Dermatol. 2011;52(2):8188.
44. Yip L, Zaloumis S, Irwin D, et al. Gene-wide association study between
the aromatase gene (CYP19A1) and female pattern hair loss. Br J Dermatol. 2009;161(2):289294.

EFFICIENCY CLINICALLY DEMONSTRATED

61% At 12 weeks stopped losing hair


73% New hair growth was significantly increased within 24 weeks in female group
60% of both groups achieved a high rate mark of satisfaction, from good to excellent
85% of the male group declarated to be highly satisfied by the treatment included
injections technique and daily care application, and are motivated to continue or
repeat the treatment course.

CLINICAL STUDY | 11
AESTHETIC DERMAL | Research & Publications

CASE REPORT
Main indication: Androgenic alopecia
Products: XL Hair, AD daily care hair

Before After

Patient age/sex: 34/Male


Area, pathology: scalp, androgenic alopecia
Type of treatment: intradermal injections, XL HAIR. Point by point injection, meso-gun
Average volume/frequency/sessions: injection of 3 ml, 1 treatment/week, average
8 treatments
Daily home care: AD daily care Hair, topical application 3 times/ week, 8 weeks
Combination treatment: -
Comments: exceptional improvement of hair density, stop of hair loss

Information about the doctor:

Name: Gabriel
Surname: Siquier
Country: Netherlands
Speciality: Aesthetic medicine practitioner
Web adress: info@dametoclinic.com
The company Aesthetic Dermal S.L. thanks Dr. Gabriel Siquier for his ennergy and effort to participate
the study of RRS products

12 | XL HAIR
AESTHETIC DERMAL | Research & Publications

CASE REPORT
Main indication: Hair line enlargement
Product: Reparestim Hair TD, AD daily care hair

Before After

Patient age/sex: 22/female


Area, pathology: scalp
Type of treatment: microneedling (AD Roll TD 0,5 mm) followed by topical application
of Reparestim Hair TD
Average volume/frequency/sessions: 3 ml, 1 treatment/week, average 8 treatments
Daily home care: AD daily care Hair, topical application 3 times/ week, 8 weeks
Combination treatment: -
Comments: Evident improvement of hair density and appearance

Information about the doctor:

Name: Jane
Surname: Ranneva
Country: Spain
Speciality: Dermatologist, aesthetic medicine practitioner
Web adress: drranneva@clinicahera.es
The company Aesthetic Dermal S.L. thanks Dr. Jane Ranneva for her enthusiasm in the development of
RRS products

CLINICAL STUDY | 13
AESTHETIC DERMAL | Research & Publications

CLINICAL STUDY TO EVALUATE THE EFFICACY OF A COMBINED TREATMENT:


MICRONEEDLING DEVICE, XL HAIR, AD DAILY CARE HAIR, IN DIFFERENT BALDNESS PATTERNS.

HAIR PULL TEST

The hair pull test is a simple diagnostic test in which the physician lightly pulls a small amount of hair (approx 100
simultaneously) in order to determine if there is excessive loss (normal rante is 1 to 3-5 hairs per pull).

BEFORE TREATMENT 3 MONTHS AFTER TREATMENT 6 MONTHS AFTER TREATMENT

More than 5 More than 5 More than 5


More than 20 More than 20 More than 20
More than 50 More than 50 More than 50
More than 100 More than 100 More than 100

DIAGNOSTICS TESTS NORMAL (lab) RESULTS (pat)

Hormone levels (DHEAs, testosterone, androstenedione, prolactin, follicular


stimulating hormone, and leutinizing hormone)
Serum iron
Serum ferritin
Total iron binding capacity (TIBC)
Thyroid stimulating hormone (T3, T4, TSH)
VDRL (a screening test for syphilis)
Complete blood count (CBC)

SAVIN TEST - MEN (tick the type of alopecy)

14 | CLINICAL STUDY
AESTHETIC DERMAL | Research & Publications

CLINICAL STUDY TO EVALUATE THE EFFICACY OF A COMBINED TREATMENT:


MICRONEEDLING DEVICE, XL HAIR, AD DAILY CARE HAIR, IN DIFFERENT BALDNESS PATTERNS.

SAVIN TEST - WOMEN (tick the type of alopecy)

Paresthesia in alopecia area


YES NO

RECOMMENDED SESSIONS: 1 per week, 8 sessions.

EVALUATION For more information about participating, please contact us: pharma@aestheticdermal.com
EVALUATION

Doctors evaluation of the results EXCELLENT GOOD SATISFACTORY NON-SATISFACTORY

Patients evaluation of the results EXCELLENT GOOD SATISFACTORY NON-SATISFACTORY

Physicians and clinic name


Phone / Fax
E-mail
Signature and date of the filling in

TRANSEPIDERMAL
P E N E T R AT I O N E N H A N C E M E N T

Patented Design

15 | XL HAIR CLINICAL STUDY | 15


AESTHETIC DERMAL | Research & Publications

XL HAIR
Hair energy & anti aging - Symptomatic hair loss - Alopecia
- Different patterns of baldness. No age limit*
box of 6 vials / 12 vials
containing 3 ml (0,10 Fl.oz.)

HA, non-cross-linked
BIOREVITALIZATION SOLUTION

FGF, GM peptide, Sodium DNA, amino acids,


trace elements, vitamins, terpenes, fatty acids,
flavonoids, antioxidants

MESO TREATMENT
OF SCALP
Area: scalp
Average volume/session: 3ml area
Type of injection: Micro dermal papule or nappage/32G
Frequency: 1 session / week 1 protocol = 4-12 sessions average, 1
session / 2 weeks: 2 months
Recommended number of sessions: Repeat protocol as necessary
Combination with other aesthetic treatments:
RRS injection can be done immediately before microneedling device
Home care: Daily Care Hair

RRS XL Hair must be used under appropriate aseptic After the treatment
conditions in an authorized clinic on healthy, disinfected skin. Avoid extreme temperatures
Saunas - Hammam
Before the treatment Direct exposure to sun or UV
Before the treatment, the physician should inform the patient: From next day make-up can be used
- about indications and effects
- the possibilities of the side effects (pain, redness, ecchymosis, Contraindications:
stinging sensations and swelling, local inflammation, usually Allergy to any of the ingredients. Patients presenting any skin
disappearing in 24 hours) alteration, skin disease, infections or sequelae of streptococcal
- check allergy test infections. Patients taking immunosuppressants, undergoing
Sensitive skins may benefit from application of an anaesthetic cortical therapy, with autoimmune disease history, patients
cream prior to the treatment with uncompensated diabetes, acute joint rheumatics,
We recommend to have a consent signed by the patient. repetitive angina, and endocarditis.

*No studies are available for use during pregnancy and breastfeeding or in case of MORE INFORMATION IN RRS-INJECT.COM/MEDINET
treatment on children or minors under 18.

16 | XL HAIR
AESTHETIC DERMAL | Clinical Results

Before/After Before/After

XL HAIR | 17
AESTHETIC DERMAL | In Vitro Study

XL HAIR - Proliferation of human papilla cells. In vitro study


SUMMARY

An in vitro test has been performed on XL HAIR for efficacy assessment on Human Hair dermal
papilla cells. Cell proliferation following the exposure to the actives in particular conditions has
been evaluated.
Cell proliferation after starving at different end times througt the MTT assay: cell viability assay using
cultured dermal papilla cells from human hair follicles to assess the cell proliferation following
exposure to the test sample.
On the basis of the tests carried out, under the adopted experimentsl conditions, the sample of the test substance.

XL HAIR

Is able to increases cells proliferation with respect to untreated control cell cultures.
The highest effect (+23.3%) is pointed out at 1mg/ml of active substance after a 48 hours exposure-period.

INTRODUCTION

On behalf of AESTHETIC DERMAL an in vito test has been performed for efficacy assessment of the test product XL HAIR,
using Human Hair dermal papilla cells. The study was performed in Abich laboratory, located in Via 42 Martiri, 213/B - 28924
- Verbania - Italy.

The experimentation started on 9th June 2014 and ended on 12th June 2014.

Cells Human Hair dermal papilla cells


Culture plate 24 wells plate
(cellular) 15000 c/well
Culture Medium Mesenchymal stem cell medium +2,5% FBS N
mitochondrial
reductase
N NH
N
Cell synchronization 6 hours starvation N
N
N
N
N N
Cell activation Serum free medium +/- product dilution S
S
Br
Proliferation assay MTT assay
MIT OD = 500 nm Formazan
Result expression % cell viability = [OD (500mm - 690mm) test
product/OD (500mm - 690mm) negative control]
x 100
Replicates 3

160
% cell viability

140
23% increase

120

100 Stimulates papilla cells


0.2 mg/ml 1 mg/ml REGENERATION
XL HAIR 23% proliferation gain

18 | STUDY IN VITRO
AESTHETIC DERMAL

New aspects of the treatment of


ALOPECIA AREATA
Ligia Brzeziska-Wciso1, Beata Bergler-Czop1, Dominika Wciso-Dziadecka2, Anna Lis-wity1
1
Dermatology Department, Medical University of Silesia, Katowice, Poland Head of Dep.: Prof. Ligia Brzeziska-Wciso MD, PhD
2
The Institute of Structural Research of Skin, Cosmetology Department of Medical University of Silesia, Katowice, Poland - Head of Dep. : Krzysztof Jasik PhD

Alopecia areata (AA) is a disease involving non-scarring hair loss determined by autoimmune
disorders and inflammation. The disease affects hair on the scalp and/or other parts of the body.
The AA occurs in people of all ages and affects 12% of humans. The purpose of this paper is to
present the latest knowledge on the treatment of AA. The decision on the type of treatment de-
pends on the type of hair loss, extent of changes, general health status, the patients age, and
his/her motivation. Treatment methods should be chosen individually for each patient.
Alopecia areata (AA) is a disease involving non-scarring hair loss determined by autoimmune dis-
orders and inflammation. The disease affects hair on the scalp and/or other parts of the body. The
AA occurs in people of all ages and affects 12% of humans. Clinical forms of AA include [1,2]:
alopecia areata focalis hair loss occurs in patches on the scalp or on other parts of the body (e.g.
face, abdomen, extremities),
alopecia areata totalis the loss of all hair on the scalp (including eyebrows and eyelashes),
alopecia areata universalis the loss of all or almost all body hair,
alopecia maligna is a generalized long-term loss of hair, resistant to treatment,
ophiasisoralopecia areata marginata snake-shaped hair loss around the circumference of the
head in the temporal, occipital and frontal areas,
ophiasis inversus the inverse pattern of hair loss, which expands from the central to the marginal
area of the head,
alopecia areata diffusaoralopecia areata reticularis diffuse or reticular hair loss where no sepa-
rate bald patches can be distinguished.

Nails are affected in about 760% of Because the aetiology of AA remains


patients. Aberrations include: koilonychia, unknown, the treatment is symptomatic
trachyonychia, Beau lines, onychorrhexis, and does not prevent disease relapse. The
nail pitting, onychomadesis, onycholysis efficacy of many treatment methods has been
and haemorrhagic spotting of the lanula. questioned by many scientific authorities
Poor prognostic factors include bald patches due to the lack of reliable clinical studies (the
persisting for more than 1 year, aggravation possibility of spontaneous hair regrowth and
or onset of hair loss before puberty, positive very few double-blind placebo-controlled
family history of AA, ophiasis pattern of clinical studies). The decision on systemic
involvement, associated nail changes, atopy, treatment depends on the type of hair
and Down syndrome[1]. loss, the extent of changes, general health
Typical pathological changes are manifested as status, the patients age and motivation, and
a well-separated bald spot. Skin in bald patches concomitant diseases. Treatment methods
may be slightly depressed due to reduced should be chosen individually for each
mass of hair follicles, and mild erythema may patient.
develop in some cases. There is no atrophy, The disease course is difficult to predict because
and on the margins, exclamation mark hair spontaneous remissions are frequently
(thick and broken off) is present. Regrowing observed, while in about 5% of cases the
hair may demonstrate pigment alteration or a disease progresses into total alopecia, and in
change in texture (i.e. straight or curly) [2]. 1% of cases into universal alopecia [3,4]. After

Articles | 19
AESTHETIC DERMAL | New aspects of the treatment of alopecia areata

completed treatment patients intravenously on 3 consecutive


must be informed about the high days monthly for 3 months.
risk of disease relapse [5]. According to these researchers,
In emotionally unstable patients, pulse methylprednisolone therapy
each exacerbation of hair appears to be a safe treatment
loss symptoms may lead to a option.
depression phase. In patients Staumont-Salleet al. carried out a
with psychoneurotic disorders, 10-year-long assessment of pulse
increased hair loss is an underlying methylprednisolone therapy for AA [7].
symptom of psychopathic The study included 60 patients
personality. In frequent cases, treated between 1995 and 2000
patients may have difficulties in and confirmed the low efficiency,
interpersonal relations at the both short- and long-term, of this
workplace [4] or in their private life treatment for AA.
(withdrawal from active social life). Researchers from Saudi Arabia [8]
Alopecia areata is diagnosed evaluated the efficacy and safety
based on trichoscopy, the of methylprednisolone for severe
hair pull test and trichogram. therapy-resistant AA, and found
Histopathological examination that the use of this drug in severe
can be carried out if diagnosis is forms of AA has relative efficacy
uncertain. Trichoscopy is a modern and tolerance, but with a high
method and is very useful in the relapse rate.
monitoring of treatment for AA and In 2011, Alsantali presented a
the evaluation of its efficacy. This new treatment plan for AA in
pict. 1/2 Alopecia areata. (Pictures dont
is a non-invasive, easy to use and Clinical Cosmetic Investigative
relate to the original article) painless test, which enables the Dermatology. According to this
objective assessment of disease plan, glucocorticosteroids are a
activity. Patients need no hair third-line option in the treatment of
shaving or dying, images can be AA. This includes: a once-monthly
recorded, and the only requirement pulse of 300 mg methylprednisone
is the considerable experience of (or a once-monthly pulse of 200
the operator. mg), intramuscular triamcinolone
The purpose of this paper is to acetonide of 40 mg once monthly
present the latest knowledge on or oral dexamethasone of 0.5 mg/
the treatment of AA. day [9].
Systemic glucocorticosteroids Some researchers from Iran
have been used in the treatment concluded that the use of
of AA for many and in different methotrexate (1525 mg once a
modalities. Generally, they offer week for 3 months) alone or with
better outcomes in patients with low doses of glucocorticosteroids
multifocal AA than in patients or azathioprine alone is an
with other forms of the disease. effective treatment in patients
Turkish scientists [6], in their paper with severe and chronic AA. This
on pulse methylprednisolone therapy may be an alternative
therapy for the treatment of option in the treatment of
extensive AA, suggested that patients with moderate to severe
therapy might be an option for forms of AA (due to safety and
severe multifocal AA, but in alopecia efficacy). The study included 20
totalis or universalis treatment patients who had a 6-month-
results are unsatisfactory. The long history of hair loss. Patients
study was carried out on 15 received 2 mg/kg body weight of
pict. 3/4 Histology Alopecia areata adult patients who received azathioprine for 6 months. Hair
(Images dont relate to the original article) methylprednisolone of 500 mg regrowth was achieved in 53% of

20 | Articles
AESTHETIC DERMAL | New aspects of the treatment of alopecia areata

14
patients and the drug prednisone) may modify the immune system
was well tolerated and increase the number of Treg cells,
[10]
. resulting in hair regrowth in patients with AA
Droitcourt et al.
[12]
. Hair regrowth was achieved in 100% of
treated patients patients and 22% of patients had a relapse of
suffering from severe hair loss 3 months after the termination of the
treatment. Authors emphasized the efficacy

RRS
AA using high-dose
pulse therapy with of this method mainly in patients with AA
methylprednisolone resistant to treatment.
New products are (500 mg Limitations on the use of cyclosporine in the
unique in compositions.
intravenously per treatment of AA result from the high relapse
Aesthetic Dermal day for 3 consecutive rate after the termination of therapy, the need
company developed a days monthly over 3 for long-term drug administration, and adverse
new line of injectable months) plus 15 mg effects, e.g. nephrotoxicity [5].
products based on of methotrexate once
RRS technology.
Ito et al. [14] concluded that spontaneous
a week for the same remission occurs in 80% of patients with AA
RRS products are
treatment period [11]. within 1 year, and not all patients require intense
medical devices made Of the 14 patients therapy, and therefore watchful observation is
in conformity with (20 patients were one of the therapeutic options. However, when
Regulation 93/42/CEE. treated), 10 had total hair loss is progressing, treatment becomes
rrs-inject.com
hair regrowth and necessary, and pulse methylprednisolone
aestheticdermal.com 4 had incomplete should be preferred.
but satisfactory Korean scientists studied the effects of
Advertising doesnt relate to
original article regrowth. Treatment intradermal botulinum toxin injections on AA
was well-tolerated. (3 times on each side of the head). One patient
The analysis of many research papers has reported aggravation, and the remaining
revealed a general controversy about the patients had no local improvement. These
administration of glucocorticosteroids. Most results suggest that botulinum toxin injections
researchers reported that the therapeutic are not useful as a treatment in AA [15].
outcome is short-lasting and the withdrawal Some scientists from Iran claim that
of medication is followed by hair loss. antidepressant treatment may result in
According to Miteva and Tosti [12], better improvement in local conditions in patients
therapeutic outcomes have been observed with AA who have depressive disorders [16].
when treatment begins before the end of Other scientists claim that hypnotherapy
3 months following the onset of the first may be effective in achieving a significant
symptoms in patients with universal alopecia, improvement and maintaining good emotional
and before the end of 4 to 6 months in patients status and life quality in patients with resistant
with focal AA. Pulse therapy based on the AA.
very short administration of high doses of
glucocorticosteroids is associated with The use of biologics in the treatment of AA
a lower number of adverse effects. Such was also tested but no significant efficacy
therapy should be considered in adults with was shown, and there are some reports on
total or universal alopecia resistant to topical aggravation during therapy [17].
treatment or phototherapy [5]. Luket al. [18] studied the efficacy and safety of
Bhatet al.[ 13] assessed levels of trace elements diphenylcyclopropenone (DPCP) in Chinese
(zinc, copper and magnesium) in patients patients with AA resistant to treatment
with AA. Fifty patients were studied. Samples with steroids and reported a good response
were analyzed using atomic absorption achieved in over 50% of treated subjects.
spectrometric methods. Serum zinc levels were Campuzano-Maya, of Colombia, described
decreased in AA patients compared to healthy the case of a 43-year-old patient with an
controls. Serum copper and magnesium levels 8-month history of AA of the scalp and beard.
showed an insignificant rise. The urea breath test confirmed Helicobacter
The combination therapy (PUVA with 20 mg pyloriinfection. The patient went into remission

Articles | 21
AESTHETIC DERMAL | New aspects of the treatment of alopecia areata

from AA afterH. pylorieradication [19]. alone. Sulphasalazine is an efficient drug in


There were also attempts to treat patients cases resistant to other treatment methods,
with AA with exposure to narrow-UVB to but offers a much poorer outcome in patients
the medium total dose of 63.9 J/cm2 or who had disease onset in childhood [5].
bexarotene gel, and different regrowth was In some patients there is a clear correlation
achieved [20,21]. between AA and the nervous system function,
There are also reports describing the effects and bald patches may occur suddenly after
of locally administered vitamin D analogues in severe emotional trauma, both in children
the treatment of AA, and a comparative study and adults. According to Manolacheet al., the
on local treatment with 0.05% clobetasol and most frequent stressful events include the
1% pimecrolimus, where similar efficacy beginning of school or pre-school education,
was found for both products [22]. exams, change of school/group, problems with
Researchers from Iran determined the teachers, intensive studying, social problems
efficacy of topical triiodothyronine in patients with peers, death in the family, family financial
with patchy AA. Ten patients with AA were problems, emigration of parents for work
treated with topical triiodothyronine and reasons, concomitant diseases and surgical
placebo applied twice daily. Hair regrowth procedures [24].
was evaluated every 4 weeks. Blood count, In addition, Willemsenet al. carried out a study
along with thyroid function (T3, T4 and TSH) to investigate whether adult AA is associated
and liver function were also tested. After 12 with childhood or total lifetime traumatic
weeks of treatment, there was no statistically events. The study was carried out using the
significant difference between the outcome Traumatic Experiences Checklist [25]. Ninety
in the active treatment and placebo groups. patients and 91 people from the control group
Triiodothyronine was safe but not more were surveyed. The study demonstrated that
effective than placebo [23]. the frequency of AA is affected by lifetime
Literature data on the effects of traumatic events. Also, there was an increased
sulphasalazine on the treatment of AA can be history of childhood trauma in patients with
compared with the efficacy of cyclosporine AA compared with control subjects.

Picture and information bellow dont related to the original article

Trichotillomania (TTM) is a behavioral disorder characterized by recurrent and


overwhelming urges to pull out body hair, accompanied by a sense of pleasure and
relief after the hair has been plucked. Although the exact incidence of TTM is not
known, it is estimated to affect as high as 4% of the population. TTM appears to be
common in children and adolescents. Despite the adult cases who generally develop
a chronic course and exhibit an accompanying psychopathology, in children TTM is
usually a self-limited benign condition often considered to be a simple habit disorder.
Interantional Jurnal of trichology/ Year : 2014 | Volume : 6 | Issue : 2 | Page : 77-79

pict. 1 Trichotillomania, female patient before treatment pict. 2 Female patient after treatment with XL Hair once per week
AD Daily Care Hair once per day, 4 weeks (courtesy dr. Ranneva)

22 | Articles
AESTHETIC DERMAL | New aspects of the treatment of alopecia areata

Alsantali [9], in his paper published in Clinical 1525 mg/weekly for 3 months, cyclosporine
Cosmetic Investigative Dermatology, A, azathioprine, biologics and psychological
presented new treatment options for AA. support. Other therapies mentioned by
First-line therapies include intralesional Alsantali that have some degree of success
triamcinolone acetonide injections include garlic gel, azelaic acid, topical onion
(2.510 mg/ml, maximum volume of 3 juice, imiquimod, calcineurin inhibitors,
ml in a single injection, repeated at 46 botulinum toxin and photodynamic therapy.
weekly intervals). The drug can also be An important element of the management
administered using mesotherapy multi- of AA is offering psychological support
injectors. Other treatment options include to stimulate increased self-esteem and
topical corticosteroids (creams, gels, adaptation to this disease. Some patients with
ointments, lotions, and foams), followed by AA require the support of a psychologist or
minoxidil, anthralin, topical immunotherapy, psychiatrist. With psychological support and
prostaglandin analogues, topical retinoids education of the patient about the disease,
and capsaicin [9]. Second-line therapies long-term improvement can be achieved [1,3].
include oral sulfasalazine of 500 mg twice It is also worth noting that when AA is limited
daily at the start, then 1 g twice daily for 1 to a single patch, the best option in most
month, and then 1 g three times daily for patients is leaving it untreated, as 80% of
3 months, PUVA, PUVA-turban, excimer patients with single patches present for less
laser and fractional photothermolysis than one year go into spontaneous remission [26]
laser. Third-line therapies include systemic
corticosteroids (pulse doses), methotrexate

References
1. Brzeziska-Wciso L, Lis-wity A. Hair diseases whats new? In: Szepietowski J, Reich A, editors.Dermatology whats new? [Polish]Wrocaw: Cornetis; 2009. pp. 187200.
2. Burgdorf WHC, Plewig G, Wolff HH, Landthaler M.Braun-Falco Dermatology [Polish]Lublin: Czelej; 2010. Hair diseases; pp. 105383.
3. Brzeziska-Wciso L, Lis A, Kamiska G, Wciso-Dziadecka D. Physiology and pathology of hair growth and loss on the human scalp [Polish]Postep Derm Alergol.2003;20:2606.
4. Brzeziska-Wciso L, Wciso-Dziadecka D, Meszyska E, et al. New perspectives on the pathogenesis and treatment of hair disorders.Post Nauk Med.2012;10:8005.
5. uczak M, uczak T, Cieciska C, Czajkowski R. General treatment of alopecia areata [Polish]Przegl Dermatol.2013;100:538.
6. Acikgz G, Ozmen I, Cayirli M, et al. Pulse methylprednisolone therapy for the treatment of extensive alopecia areata.J Dermatolog Treat.2014;25:164-6
7. Staumont-Sall D, Vonarx M, Lengrand F, et al. Pulse corticosteroid therapy for alopecia areata: log-term outcome after 10.Dermatology.2012;225:817.
8. Bin Saif GA, Al-Khawajah MM, Al-Otaibi HM, et al. Efficacy and safety of oral mega pulse methylprednisolone for severe therapy resistant Alopecia areata.Sudi Med
J.2012;33:28491.
9. Alsantali A. Alopecia areata: a new treatment plan.Clin Cosmet Investig Dermatol.2011;4:10715.
10. Farshi S, Mansouri P, Safar F, Khiabanloo SR. Could azathioprine be considered as a therapeutic alternative in the treatment of alopecia areata? A pilot study.Int J
Dermatol.2010;49:118893.
11. Droitcourt C, Milpied B, Ezzedine K, et al. Interest of high-dose pulse corticosteroid therapy combined with methotrexate for severe alopecia areata: a retrospective case
series.Dermatology.2012;224:36973.
12. Miteva M, Tosti A. Treatment options for alopecia: an update looking to the future.Expert Opin Pharmocter.2012;13:127181.
13. Bhat YJ, Manzoor S, Khan AR, Qayooni S. Trace element levels in alopecia areata.Indian J Dermatol Venereol Leprol.2009;75:2931.
14. Ito T, Aoshima M, Ito N, et al. Combination therapy with oral PUVA and corticosteroid for recalcitrant alopecia areata.Arch Dermatol Res.2009;301:37380.
15. Cho HR, Lew BL, Lew H, Sim WY. Treatment effects of intradermal botulinum toxin type A injection on alopecia areata.Dermatol Surg.2010;4:217581.
16. Abedini H, Farshi S, Mirabzadeh A, Keshavarz S. Antidepressant effects of citalopram on treatment of alopecia areata in patients with major depressive disorder.J Dermatolog
Treat.2014;25:1535.
17. Otberg N. Systemic treatment for alopecia areata.Dermatol Ther.2011;24:3205.
18. Luk NM, Chiu LS, Lee KC, et al. Efficacy and safety of diphenylcyclopropenone among Chinese patients with steroid resistant and extensive alopecia areata.J Eur Acad
Dermatol Venereol.2013;27:e4005.
19. Campuzano-Maya G. Cure of alopecia areata after eradication of Helicobacter pylori: a new association?World J Gastroenterol.2011;17:316570.
20. Bayramgrler D, Demirsoy EO, Aktrk AS, Kiran R. Narrowband ultraviolet B phototherapy for alopecia areata.Photodermatol Photoimmunol Photomed.2011;27:3257.
21. Raijiv M, Singh N. Bexarotene gel: a new topical therapy for alopecia areata.Int J Trichology.2010;2:667.
22. Ucak H, Kandi B, Cicek D, et al. The comparison of treatment with clobetasol propionate 0,05% and topical pimecrolimus 1% treatment in the treatment of alopecia areata.J
Dermatolog Treat.2012;23:41020.
23. Nasiri S, Haghpanah V, Taheri E, et al. Hair regrowth, with topical triiodothyronine ointment in patients with alopecia areata: a double-blind, randomized pilot clinical trial of
efficacy.Eur Acad Dermatol Venereol.2012;26:6546.
24. Manolache L, Petrescu-Seceleanu D, Benea V. Alopecia areata and relationship with stressful events in children.J Eur Acad Dermatol Venereol.2009;23:1079.
25. Willemsen R, Vanderlinden J, Roseeuw D, Haentjens P. Increased history of childhood and lifetime traumatic events among adults with alopecia areata.J Eur Acad Dermatol
Venereol.2009;60:38893.
26. MacDonald Hull SP, Wood ML, Hutchinson PE, et al. British Association of Dermatologists. Guidelines for the management of alopecia areata.Br J Dermatol.2003;149:6929.

Postpy Dermatologii i Alergologii 4, August / 2014


Aesthetic Dermal Thanks to authors for the possibility to reprint the article

Articles | 23
AESTHETIC DERMAL | Focus on hair coloring

XL Hair, Reparestim TD Hair, AD Daily care Hair

Focus on hair coloring


& scalp problems

pict 1. Female patient with hair loss and scalp irritation after hair bleaches pict 2. Female patient after treatments with Reparestim Hair. 4 sessions once a week
(Courtesy of Dr. Ranneva) by using microneedling device - 0,5 mm , AD Daily Care Hair once per day 4 weeks
(Courtesy of Dr. Ranneva)

Throughout the ages, society has influenced


hairstyle trends crew cut, straight vs. curly HAIR CHEMICALS THAT HAVE BEEN ASSOCIATED
hair, hair coloring, etc. which leaves the scalp WITH SENSORY IRRITATION OF THE SCALP
exposed to different chemicals (eg, dyes, highlights, Hydrogen peroxide
straightening agents, etc.), hair styling gadgets (eg, Ammonium persulfates
blow dryers, curling or straightening irons, etc.) p-Phenylenediamine
and hair-care products (rinse-off or leave-on Thioglycates
preparations). All of this may lead to scalp irritation.2
Heidi P. Chan, MD, Hongbo Zhai, MD, and Howard I. Maibach, MD

NEW ENERGY FOR YOU HAIR


AD Daily Care Hair

Extensive sun explosure can turn the hair into a brittle, dry mop that breaks and splits easily.
Choosing AD Daily Care Hair wich provides full vitamin nutrition became good recommendation for the patients.

xl-hair.com

24 | CLINICAL CASE
AESTHETIC DERMAL | Research & Publications

XL Hair
A new medical approach for alopecia areata

Gabriel Siquier1 and Evgeniya Ranneva2
1-aesthetic medicine practicioner (Netherlands)
2-phd, dermatologist (Spain)

Abstract: Alopecia areata is a non-scarring hair loss disease that affects 1-2% of human population. For
such a prevalent disease it is surprising that its etiology is not fully understood and treatment still poses a
challenge with little therapeutic options that commonly have many side effects. XL Hair formula contains
growth factors, macro and micro-nutrients and matrix remodeling actives that prolong the anagen phase
of hair growth. It has already been proved effective on other types of non-cicatricial hairloss like alopecia
androgenetica. In this case study, an AA patient is treated with once a week intradermal injections of XL
Hair formula achieving astonishing results within the first 6 weeks of treatment (hair regrowth achieved
after 3 weeks). The side effects reported were swelling and ecchymosis that lasted for 24-48h after the
procedure. This encouraging result strengthens the evidence that XL Hair is a promising new therapy for all
types of non-cicatricial hairloss.

Introduction
Alopecia Areata (AA) is a non-scarring Even though the etiology of AA is still
hair loss disease with prevalence of unknown, most specialists believe
0.1-0.2% (calculated lifetime risk of that it is an autoimmune disease
2%) depending on ethnic and world caused by the breakdown of the
region1. It affects both sexes with immune privilege of the hair follicle
some studies showing slightly higher and invasion of T lymphocytes which
prevalence on men (1.4:1 ratio)2. Most results in shortening of the anagen
patients (66%) are younger than 30 phase of hair growth and acute
years old3 and earlier onset of the hair loss6. Like most autoimmune
disease is associated with poorer diseases, AA has a strong genetic
prognostics 2. It is characterized component and familial cases have pict 1. Female patient with Alopecia areata
as hair loss and thinning in a well- poorer prognosis, faster progression, before treatment
circumscribed skin region most times more frequent relapses and greater
located on scalp and beard and it can resistance to therapy7,8.
evolve to total scalp hair loss (alopecia Treatment of AA is far more
areata totalis) or even total body hair challenging than its diagnostics
loss (alopecia areata universalis)4. with few, and many times ineffective,
The diagnostic may be achieved drugs available. There is no
by trichoscopy, hair pull test or known curative therapy to date
trichogram. Trichogram is being and currently treatment options
replaced by trichoscopy, which is a relies on corticosteroids that are
more modern, less painful and not taken either by injections on the
invasive method that depends only affected site, oral pills (in pulse
pict 2. Female patient with Alopecia areata
on the experience of the operator5. doses) or topical formulations after treatment

CLINICAL STUDY | 25
AESTHETIC DERMAL | Research & Publications

(creams, gels, ointments, etc)9, and etc),terpenes (Quercetin),fatty


immunosuppressive drugs like acids (Oleic Acid ,Linoleic Acid),
ciclosporin or anti-inflammatory flavonoids (Rutin, Kaempferol),
drugs like sulfasalazine10. However, antioxidants (Quercetin, Citric Acid,
all those treatments have limited Ginkgolides A- B- C- M), NAD, NADP.
success rate with often unsatisfactory Fibroblast growth factors (FGFs) and
results. Hair regrowth can be their receptors control a wide range
seen in 60-67% of the cases using of biological functions, regulating
intradermal corticosteroids and in cellular proliferation, survival,
30% of the cases treated orally with migration and differentiation. The
the same class of drugs. Relapses treatment also delivers copper pict 3. Male patient with Alopecia areata
occur frequently once treatment is peptide to the base of follicles, which before treatment
discontinued and can affect up of 25% helps strengthen hair by stimulating
of the successfully treated patients8. hair follicles to produce a strong
It is, therefore, crucial to explore hair shaft, help blood circulation
different treatment options for such in the scalp, and revitalize hair
a high prevalence disease with so follicles. Another group known
little treatment options. This article as nutritional supplementation
presents a case study of a patient including vitamins, minerals, and/
treated with XL Hair formulation or antioxidants may help in hair
which is composed of growth factors, growth and health. Vitamins are
antioxidants, aminoacids, DNA, considered micronutrients and
trace elements, vitamins, matrix occur in only very small amounts
pict 4. Injections scheme
reorganization compounds and micro within cells, but are critically
nutrients. The final target of the important as coenzymes. Amino
actives is to repair and to stimulate acids have several functions: the
hair growth, increase the thickness energy storage function (as it can be
of hair by improving skin nutrition used on Krebs cycle), the endocrine
and skin defenses against internal & integration function (hormones), the
external stress and damage factors. informative function (membrane
receptors, intracellular signals).
Treatment: Trace elements have an influence on
the binding, transport and release of
The treatment was accomplished oxygen, donate or accept electrons
by once a week intradermal in reaction of reduction or oxidation, pict 5. Xl Hair injections.
injections of the XL hair formula compensate cells nutrition and play
in the affected area (pict. 4/5). The the structural role to important
injections contained hyaluronic acid biological molecules.
0,001 mg/ml associated in XL Hair The biggest group of
with active bio revitalization solution bioreviatlization solution of XL Hair
that helps to improve the transport is antioxidants. The mechanisms
function of the actives from BS. by which these antioxidants act at
The complex actives of BS are: the molecular and cellular level
growth factors GF (Rh-Polipeptide- include roles in gene expression and
1,Copper peptide),deoxyribonucleic regulation, apoptosis, and signal
acid, amino acids (Alanine, Folic Acid, transduction. Antioxidants are
pict 6. Male patient with Alopecia
Leucine, Valine,Tyrosine ,Glycine, involved in fundamental metabolic areata after treatment
Histidine, Isoleucine, Lysine, and homeostatic processes and help
Methionine, Phenylalanine, Proline, repairing damaged biomolecules XL Hair neutralizes the
Serine, Threonine and etc),trace and defense antioxidant enzymes, functional imbalance and
elements (Ca, Fe, K, Mg, Mn, Na, P, which are mostly intracellular11. recovers hair follicle function
Se and etc),vitamins (Vit A,PP, B,H resulting in hair regrowth

26 | XL HAIR
AESTHETIC DERMAL | Research & Publications

Results: Conclusions:
The patients (pict. 1/3) had a complaint of a small Alopecia areata is a non-cicatricial hairloss
baldness spot that appeared 6 to 12 months disease. In those types of baldness, the hair
before treatment near the occipital area, this follicle is not damaged and what causes the
lesion was confirmed as AA by trichoscopy. Initial disease is an imbalance in function that may
results were accomplished after only three weeks have several etiologies. XL Hair formula is so
of treatment with visible hair regrowth and after effective because it has growth factors, macro
six weeks the bald patch was no longer visible (pict. and micro-nutrients that extends the anagen
2/6). Similar results were achieved in other non- phase of hair growth cycle and hyaluronic acid
cicatricial alopecia patients as presented on the that promotes matrix reorganization. Therefore, it
previous case series with successful regrowth in neutralizes the functional imbalance and recovers
73% of the female group and 63% on the male one hair follicle function resulting in hair regrowth.
and overall satisfaction rate of 60%11. The only side Furthermore, XL Hair have showed considerable
effects reported were swelling and ecchymosis on less side effects than conventional therapy which
the treated area that vanished 24-48h after the encourage its use for longer periods preventing
procedure. Since it is a single case study, relapse relapse. In conclusion, this case study shows
ratio cannot be defined and should be analyzed in that AA can be successfully treated by XL Hair
further research. formula with minimal side effects and therefore
puts it in advantage in comparison to standard
therapy options.
References
1. Safavi, K.H., Muller, S.A., Suman, V.J., et al, 1995. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin. Proc. 70, 628633.
2. Xiao FL, Yang S, Liu JB, et al. The epi- demiology of childhood alopecia areata in China: a study of 226 patients. Pediatr Dermatol 2006;23:13-8.
3. Kyriakis KP, Paltatzidou K, Kosma E, Sofouri E, Tadros A, Rachioti E. Alopecia areata prevalence by gender and age. J Eur Acad Dermatol Venereol 2009;23:572-3.
4. Amin S et al (2013). Alopecia areata: A review. Journal of the Saudi Society of Dermatology & Dermatologic Surgery (2013) 17, 3745.
5. Brzezinska-Wcisto et al. (2014). New aspects of the treatment of alopecia areata. Postep Derm Alergol 2014; XXXI, 4: 262265.
6. McElwee et al (2013). What causes alopecia areata? Exp Dermatol. 2013 September ; 22(9): 609626.
7. Goh C, Finkel M, Christos PJ, Sinha AA (2006). Profile of 513 patients with alopecia areata: associations of disease subtypes with atopy, autoimmune disease and positive family
history. J Eur Acad Dermatol Venereol 2006;20:1055-60.
8. Gilhar A (2012). Alopecia areata. New England Journal of Medicine, 366: 1515-1525.
9. Harries MJ, Sun J, Paus R, King LE Jr (2010). Management of alopecia areata. BMJ 2010; 341:c3671.
10. Garg S, Messenger AG. Alopecia areata: evidence based treatments. Semin Cutan Med Surg 2009;28:15-8.
11. Ranneva E, Siquier G (2014). Clinical study to evaluate the efficacy of a combined treatment with XL Hair in different baldness patterns. Aesthetic Dermal 1-8.

CE CLASS III INJECTABLE

THE RIGHT
S O L U T I O N*
INNOVATIVE FORMULAS
FROM EXCLUSIVE TECHNOLOGY
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P A R A B E N , P R E S E R V A T IV E & C O L O U R IN G F R E E

CLINICAL STUDY | 27
AESTHETIC DERMAL | REPARESTIM TD LINE

Reparestim Hair TD - AD Daily care


New approach in hair loss treatment
Optimally prepare the skin before hair transplantation

8 vials x 5 ml 100 ml (50ml spray + 50 ml refill)

Improves transport function of Fibroblast Growth Factor Improves local blood circulation Amino acids: Alanine, Arginine,
signal molecules Rh- Polypeptide-1 Nutritional suplementation Aspartic acid, Glutamic acid,
Stimulates cellular proliferation, Copper peptide Energy storage function Glycine, Histidine,
migration and cells diferentiation Vitamins: Ascorbic acid Hydroxyproline, Isoleucine,
Improves cellular metabolism (Vit. C), Retinol (Vit. A), Biotin Leucine, Lysine, Methionine,
(Vit. B8), Riboflavin (Vit. B2), Phenylalanine, Proline, Serine,
Pyridoxine (Vit B6), Folic acid Threonine, Tyrosine, Valine.
(Vit B9), Tocopherol (Vit E), Trace elements: Cu, Fe, Zn, Se,
Cyanocobalamin (Vit B12). Ca, Mg.
Nucleotides: Adenine, Vitamins: Ascorbic acid
Cytosine, Guanine, Thymine. (Vit. C), Retinol (Vit. A), Biotin
Organic Silicium (Vit. B8), Riboflavin (Vit. B2),
Hyaluronic acid Pyridoxine (Vit B6), Folic acid
(Vit B9), Tocopherol (Vit E),
Cyanocobalamin (Vit B12).
Hyaluronic acid
Flavonoids: Quercetin,
Kaempferol, Rutin.
Fatty acids: Linoleic acid,
Linolenic acid.

28 | XL HAIR
AESTHETIC DERMAL | HOW IT WORKS

REPARESTIM HAIR & AD DAILY CARE HAIR


DROP
OF
HAIR

www.aestheticdermal.com

Anti oxidant Vitamins: Ascorbic acid (Vit. C), Hydrobalance Hyaluronic acid
Helps to repair damaged Retinol (Vit. A), Tocopherol (Vit Skin matrix hydration
biomolecules E),
Improves anti oxidant defence Cyanocobalamin (Vit B12).
Terpenoids: Quercetin,
Quercetin.

Scan here

OPTIMALLY SELECTED CONCENTRATION OF MAIN ACTIVES


MAXIMUM NUTRIENTS
STIMULATION OF HAIR GROWTH FACTORS
DEFENCE AGAINST FREE RADICALS

HOW IT WORKS | 29
AESTHETIC DERMAL | Questions & Answers

Frequent

Q&A
Questions & Answers
What is XL Hair? How is used XL Hair?
XL Hair is an injectable medical device, CE XL Hair is usually injected in the scalp
certified class III, made of a non cross linked dermis, at the level of hair rooths. It also
hyaluronic acid, mainly used as a intradermal can be used transdermally, together with
carrier and associated to a Bio-stimulating microneedling.
solution
What volume is necessary for one
treatment?
3 ml are usually sufficient by session
Is any scalp preparation necessary
before treatment?.
Scalp should be clean, a disinfectant
shampoo can be recommended. Hair should
be dry and disinfected before injection.
Is injection painful?
What is the bio-stimulating
solution of XL Hair? No anaesthetic is necessary before injection;
the solution is not painful when injected.
XL Hair biostimulating solution is made of 47
active elements restoring an ideal perifollicular What are the contraindications?
matrix structure for a renewed hair growth. Allergy to one of the components; local active
What are the best indications of XL infections or irritations; No study have been
done for pregnant or breastfeeding women.
Hair ?

XL Hair has showed results in case of male Is any combination treatment


or female hairloss aswell as in case of alopecia necessary?
areata. XL Hair injections should be associated to
Are there evidences of activity? the daily application of AD Daily Care Hair
spray.
Cultivation of human hair dermal papillae
cells, mainly specialized fibroblasts, showed How quickly are expected the first
an increase of proliferation by 25%, after 48 results?
hours, demonstrating in vitro the exceptional
First results appear quickly: visible signs of
activity of XL Hair solution.
regrowth can be seen after 3 to 6 sessions.

30 | XL HAIR
AESTHETIC DERMAL | Research & Publications

How to maintain the results?


A maintenance program, combining injections

MEDINET
of XL Hair, sessions of microneedling for
enhancing the transdermal penetration
of XL Hair and regular application of AD
Daily Care Hair solution allow a long term
maintenance of results.
What is Reparestim hair and how
to use it?
Reparestim Hair TD is a sterile solution,
without conservative, specially made
for a transdermal application, using a
microneedling device. Its formula is similar
to XL Hair formula.

When to use microneedling vs


injections?
Microneedling is generally used for treating
large surfaces and injections for treating
Enter in:

smaller surfaces or alopecia areata.


What is AD Daily Care Hair?
AD Daily Care Hair is a solution that has
been specially formulated for helping to
keep or increase the results of the medical
treatment with XL Hair or Reparestim Hair
TD. The patient applies it on a daily basis or
every other day. On rrs-inject.com to
Could AD Daily Care Hair be used find more information
as a sole treatment? about injections
AD Daily Care Hair can definitively be used techniques and protocols,
as a sole treatment in any case of hair loss,
with good results. videos, articles and
clinical studies

CLINICAL STUDY | 31
xl-hair.com / rrs-inject.com / aestheticdermal.com

HAIR RESTORATION
Hairs are different

Problems are different

Solution is unique!
XL Hair
AED_HaRe2014_01

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