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4_art_celleno

J. Appl. Cosmetol. 31, 47-56 (January/June 2013)
Efficacy of a Cosmetic Caffeine Shampoo in
Androgenetic Alopecia management. II Note

T. Sisto MD, C. Bussoletti, MD, L. Celleno, MD
Department of Dermatology, Catholic University of the Sacred Heart, Largo Gemelli 8, 00168 Rome, Italy Received: March, 2012
Key words: Androgenetic alopecia; Caffeine; Hair loss;
Androgenetic alopecia (AGA) is a common, progressive, patterned loss of visible scalp hair. Theseverity and frequency are greater in men. It causes psychological distress and negative effects on thequality of life and thus the prospect of treating AGA is mandatory. Dihydrotestosterone (DHT) isresponsible for hair loss in AGA. At present only two medical treatments, minoxidil and finasteride,are licensed for the treatment of male balding. Caffeine was identified as a stimulator of human hairgrowth. We report the results of a randomised, controlled, double-blind, parallel group study toassess, in a panel of healthy men suffering from AGA, the skin compatibility of a shampoo contai-ning caffeine and to assess its anti hair loss efficacy and its cosmetic qualities, after application for 6consecutive months versus placebo. Our data support the beneficial effects of topical application ofcaffeine in AGA, suggesting it as a cosmetic growth-stimulating agent suitable for AGA treatment.
Riassunto
L'alopecia androgenetica (AGA) è una condizione comune, caratterizzata dalla progressiva perdita dicapelli. La gravità e la frequenza sono maggiori negli uomini. È fonte di stress psicologico e causaeffetti negativi sulla qualità della vita, quindi è auspicabile la ricerca di un trattamento efficace. Il dii-drotestosterone (DHT) è responsabile della perdita dei capelli osservata nell’AGA. Al momento soloil minoxidil e la finasteride sono autorizzati per il trattamento della calvizie maschile.
La caffeina è stata identificata come stimolatore della crescita dei capelli umani.
Riportiamo i risultati di uno studio randomizzato, controllato, in doppio cieco, a gruppi paralleli pervalutare, in un gruppo di uomini sani che soffrono di AGA, la compatibilità cutanea di uno shampooche contiene caffeina e per valutare la sua efficacia contro la caduta dei capelli e le sue qualità cosme-tiche, dopo l'applicazione per 6 mesi consecutivi, rispetto al placebo.
I nostri dati supportano gli effetti benefici dell’applicazione topica di caffeina nell’AGA, suggeren-dola come agente cosmetico in grado di stimolare la crescita dei capelli per il trattamento dell’AGA.
Efficacy of a Cosmetic Caffeine Shampoo in Androgenetic Alopecia management. II Note INTRODUCTION
tion of vascular endothelial growth factor(VEGF) have been proposed. The increase in The term androgenetic alopecia (AGA) descri- 5 α-reductase activity is genetic and depends on bes a form of scalp-hair loss in which there is a androgen receptor polymorphism (3). The folli-cular changes in androgenetic alopecia comprise decline in production of hair, which may even- a gradual reduction in the duration of anagen, a tually lead to balding. It affects both sexes and prolongation of the “latent phase” of the hair all ethnic groups although the severity and fre- cycle and progressive miniaturization of hair fol- quency are greater in men and there are racial licles (4). Miniaturization may eventually lead to differences in prevalence. Male AGA is a com- deletion of hair follicles. Population frequency mon androgen-dependent trait that can start at and severity of AGA increase with age. It com- any age after puberty. In the majority of men bal- monly begins by 20 years of age and affects ding is patterned, in which the two major com- nearly 50% of men by the age of 50 years. Some ponents are fronto-temporal recession and loss authors have suggested that scalp hair loss in of hair over the vertex. Hair become shorter and may, although not always, become finer in cali- androgens (senescent alopecia) but this remains ber. Ultimately, this may lead to complete hair to be verified (5). At present, only two medical loss except at the lateral and posterior margins of treatments, minoxidil and finasteride are licen- the scalp where hair is retained. In elderly men, sed for the treatment of male balding. Both drugs hair may also be lost in these parts of the scalp.
will stimulate some regrowth of hair in some Hamilton classified male balding into several men but are perhaps better regarded as preventa- stages (1) and the revision of his classification tive treatments. Neither will regrow hair on com- by Norwood is still widely used (2). The predi- pletely bald scalp and continued treatment is sposition to male balding is predominantly due necessary to maintain the response. Recently, to genetic factors. AGA is probably a polygenic certain newer advances have shown caffeine to trait, although the male hormone testosterone have beneficial effects in patients suffering from plays an important role, maybe independent of AGA (6, 7, 8, 9). We report the results of a ran- genetic predisposition. Male balding is especial- domised, controlled, double-blind, parallel group study to assess, in a panel of healthy men Dihydrotestosterone (DHT), the 5α-reduced suffering from AGA, the skin compatibility of a metabolite of testosterone, catalyzed by the shampoo containing caffeine and to assess its enzyme 5α-reductase, is responsible for hair anti hair loss efficacy and its cosmetic qualities, loss. This hormone binds to androgenic recep- after application under the normal conditions of tors (AR), and the specific bond triggers cellular use for 6 consecutive months versus placebo.
processes which reduce the anagen phase of thehair cycle. It is now commonly accepted that MATERIALS AND METHODS
male AGA is associated with an increase in 5α-reductase activity leading to an increase in local The study has been performed in 66 male sub- production of DHT. The mechanism by which jects: 33 for the Verum group1 and 33 for Placebo the local DHT increase leads to hair follicle loss group (2), matched for age, hair pull test and is not clearly demonstrated. Inhibition of cell Hamilton-Norwood Score. The individual typo- proliferation in the dermal papilla and a vascular logical characteristics of the test subjects are process based on the inhibition in local produc- Trademark: Alpecin® Caffeine Shampoo C1 Trademark: Alpecin® Medicinal Shampoo Concentrate Individual typological characteristics of the test subjects. Age (years old)
Number of hair from the
"Hair Pull Test"
Hamilton-
The informed consent form was personal and inflammatory products, antihistamine products, Inclusion criteria were: age from 18 to 55, male, Exclusion criteria were: different causes of alo- phototype (Fitzpatrick) from I to IV, androgene- pecia [alopecia areata, psychosomatic alopecia tic alopecia in the stages of Hamilton-Norwood i.e. Trichotillomania, hair loss due to medication 2-4, a hair count of the hair pull test of at mini- (immunologics, chemo-therapy, etc.)], unhealthy mum 18 hair fibers, no use any hair restorer condition of the scalp (widely spread, highly (tablet, capsule, tonic nor shampoo) since the expressed eczema, high grade of dandruff), regu- last 6 months, good health conditions, no signi- lar use of hair dye, bleaching products or pro- ficant skin disease located on scalp, able to com- ducts for permanent wave, present or past histo- promise the evaluation of skin tolerance of the ry of hypo/hyperthyroidism or iron deficiency investigational product or being possibly aggra- (at the present or in the past), known allergies to vated by the application of the investigational the same type of products as the investigational product, such as dermographism, recurrent her- products (cosmetic hygiene and care products) pes, pityriasis versicolor, psoriasis, important or other products (drugs, food), personal history pigmentary disorders (multiple lentigines, of atopy, treatment, prior to the study, able to numerous or congenital nevi), UV light induced interfere with the interpretation of the study dermatitis, urticaria, no history of organ removal results (topical or systemic medication with anti- (kidney, lung, spleen, axillary lymph nodes) or inflammatory or antihistamine products within organ transplant, no current treatment able to the 6 months, antibiotics within the 4 weeks, interfere with the interpretation of the study results, such as immunosuppressive drugs, anti- Investigational products were: a shampoo con- Efficacy of a Cosmetic Caffeine Shampoo in Androgenetic Alopecia management. II Note taining caffeine (Verum group) and a shampoo Statistics
containing placebo (Placebo group). The packa-ging of the two shampoos was identical. The The primary hypothesis was that the content- samples, in neutral packaging, were identified ment of the volunteers with the Verum was signi- by the sponsor with a progressive number from ficantly higher compared to the Placebo. This 1 to 66 according to a predefined randomization hypothesis has been tested using the exact, two- list and not known by the investigating centre.
sided fisher Test. The effect of the test products The experimental conditions adopted (experi- (group: Verum vs. Placebo) on the secondary mental areas, quantity of product applied, fre- efficacy variables has been tested using analysis quency and duration of the applications) repro- of variance (ANOVA) with repeated measure- duced the normal conditions of use advocated: ments (baseline, after 3 months, and after 6 the shampoo has been applied at home by test months). The hypothesis was that the interaction subjects, once per day for 6 months, in a quanti- time x group was significant (indicating that the ty of 7ml on hair and scalp, kept on the scalp for improvement in the Verum group was higher compared to the Placebo group). In addition, in The constraints for the test subjects during the each group it has been checked separately whe- study were: no application of any other hair pro- ther there was a significant effect on secondary ducts than the tested one, no intensive sun or efficacy parameters and scalp condition using UVA exposure (UV lamps), no colouring, hair the exact Friedman Test (one-way repeated mea- bleaching, permanent wave during the study, no sures analysis of variance by ranks).
additional vitamin supply (vitamins B or H) or Furthermore, the Mann-Whitney Test has been products which could have an effect on hair, no used to check whether there was a significant hair loss treatment by oral route, no medical tre- difference between groups at the baseline.
atments likely to induce an alopecia (antimito- Statistical tests have been performed as two- tics, anticoagulants, antithyroid agents, anticon- sided tests with an alpha-level of 0.05.
vulsants, beta-blockers, hypocholesterolemicdrugs, retinoids), no application of hair lacquer or gel, no violent brushing and repeated massa-ge of the scalp, no change of diet.
The individual answers of the questionnaires After 3 and 6 consecutive months of treatment, concerning the targeted anamnesis of each the volunteers answered a proband questionnai- volunteer are reported in Table II. After 3 and 6 re to rate the efficacy of the investigational pro- consecutive months of product use at home, no duct and the scalp conditions. Checking of the intolerance reaction has been noted by the inve- skin compatibility (local tolerance) was based on stigator and no sensation of discomfort has been a skin examination of the experimental area, described by the volunteers. The primary effica- before and after product use, by the investigator.
cy parameter was the contentment of the sub- This examination had to be performed, visually, jects with test product after 6 months of applica- under standard daylight source, at baseline then tion. The results are shown in Table III.
after 3 and 6 consecutive months of treatment.
Compared to the Placebo (36.4%), the content- On the basis of this examination, the investigator ment of the subjects with the Verum (84.8%) filled in a dermatological questionnaire to rate was significantly higher after 6 months of appli- the efficacy of the investigational product and cation (p<0.001, two-sided, exact Fisher Test).
Since when do you suffer from increased hair loss?
Test subjects
Question
Hair length?
Do you know about other cases
of androgenetically pattern
hair loss?
Do you have problems
with your scalp?
Which kind of problems?
How often do you feel that?
Do you feel the increased hair
loss permanently?
Is there a typical season for
your hair loss?
Do you ever treat or medicate
against this problem?
If yes, have you been satisfied
by that treatment?
Can you tell the products having
applied in the past?
Efficacy of a Cosmetic Caffeine Shampoo in Androgenetic Alopecia management. II Note TABLE III
Contentment with the test product. Test product
Are you satisfied with the product?
This was already the case (6.1% vs. 33.3%) after 3 months of application of the test products p=0.002). The strength and thickness of the hair (p=0.011, two-sided, exact Fisher Test). significantly improved during application of the Furthermore, the efficacy of the shampoos has test product in the Verum group (p<0.001, exact been assessed by the volunteers using a que- Friedman Test), but not in the Placebo group stionnaire at baseline, after 3 and 6 months of (p=0.111, exact Friedman Test). ANOVA confir- application of the shampoo. Secondary efficacy med that the improvement was more pronounced variables were: intensity of hair loss, decrease or in the Verum group compared to the Placebo normalization of hair loss, number of hairs fal- group (time x group interaction: p<0.001).
ling out while combing, thickness of the hair.
Compared to the Placebo (36.4%), significantly After 6 months, the subjects have been asked if more subjects would like to continue with the they would like to continue with the test product.
Verum (84.8%) [p<0.001, two-sided, exact According to the evaluation by the subjects, the intensity of hair loss significantly improved The efficacy of the shampoos has been assessed during application of the test product in the by the investigators using the dermatological Verum group (p<0.001, exact Friedman Test) questionnaire at baseline, after 3 and 6 months of and in the Placebo group (p<0.001, exact application of the shampoo. The following effi- Friedman Test). ANOVA demonstrated that the cacy variables have been assessed: strength of improvement in intensity of hair loss was more hair, progression of the balding, extent of the fal- pronounced in the Verum group compared to the ling out of hair. The strength and the thickness of hair significantly improved during application of the test product in the Verum group (p<0.001, decrease/normalization of hair loss was signifi- exact Friedman Test) and in the Placebo group cantly more pronounced in the Verum group compared to the Placebo group (p<0.001, exact Mann-Whitney Test). The number of hair in the more pronounced in the Verum group compared basin significantly decreased during application to the Placebo group (time x group interaction: of the test product in the Verum group (p<0.001, p<0.001)(Table IV). The balding significantly exact Friedman Test) and in the Placebo group improved during application of the test product in the Verum group (p<0.001, exact Friedman demonstrated that the decrease was more pro- Test), but not in the Placebo group (p=0.333, nounced in the Verum group compared to the exact Friedman Test). ANOVA confirmed these results (p<0.001) (Table V). The extent of the tor was asked (multiple choice question) to eva- falling out of hair significantly improved during luate the efficacy of the test product. According application of the test product in the Verum to the evaluation by the investigator, Verum group (p<0.001, exact Friedman Test) and in the reduced the premature hair loss in 24 subjects Placebo group (p<0.001, exact Friedman Test).
(72.7%), whereas this was the case only in 11 subjects (33.3%) who applied the Placebo. The more pronounced in the Verum group compared investigator preferred significantly more often to the Placebo group (time x group interaction: the Verum (72.7%) compared to the Placebo p=0.002) (Table VI). Furthermore, the investiga- (33.3%) (p=0.003, two-sided, exact Fisher Test).
How do you rate the strength of the hair?
very thin
How do you rate the progression of balding?
very slight
moderate
Efficacy of a Cosmetic Caffeine Shampoo in Androgenetic Alopecia management. II Note Extent of the falling out of hair. How do you rate the extent of the out falling hair
Please, comb the hair several times and make a
very slight
moderate
semi-quantitative rating
DISCUSSION
AGA is a common, progressive, patterned loss effect of testosterone on the cultured hair folli- of visible scalp hair. It causes psychological distress and negative effects on the quality of life The stimulatory effect of lower concentrations of and thus the prospect of treating AGA, a caffeine may be partly due to the increasedworldwide trichological problem, is mandatory.
levels of cyclic AMP and partly due to a direct Caffeine is a methylxanthine, a well-known sub- effect against apoptosis, which is induced in stance, but its effect on human hair follicle growth is not yet defined. The proposed mecha- Brandner et al. (7) proved by their double-blind placebo-controlled trial that caffeine application miniaturization of the hair follicle include inhi- causes a substantial reduction in the transepider- bition of phosphodiesterase by caffeine, which mal water loss in men compared to women, thus increases cAMP levels in cells and therefore pro- motes proliferation by stimulating cell metabo- In the past, it has been assumed that the intercel- lism10. The beneficial effects of topical applica- lular route was the only relevant penetration tion of caffeine in AGA can also be attributed to pathway for topically applied substances. Recent improvement in barrier function, follicular pene- results on follicular penetration emphasize that tration, stimulation and promotion of hair the hair follicles represent a highly relevant and growth. Thus it appears to be a useful adjuvant efficient penetration pathway and reservoir for Fischer and colleagues (6) used ex vivo hair fol- A recent study, which assessed the follicular licles from balding areas of men with AGA and penetration of topical caffeine in hair follicles, cultivated them in vitro with different concentra- proved hair follicles to be faster route of drug tions of caffeine to study its stimulatory effects delivery for topically applied drugs (8).
on the hair follicles. It has been shown that An important requirement for the treatment of 0.001% of caffeine prevented the suppressive AGA is follicular drug delivery. Another recent study assessed the follicular penetration of caf- feine on topical application in a shampoo formu- At the end of the study, the investigator preferred lation for 2 min and showed that penetration via significantly more the Verum than the Placebo.
hair follicles was faster and higher compared Our data support the beneficial effects of topical with the interfollicular route and that hair folli- application of caffeine in AGA, suggesting that cles were the only pathway for faster caffeine this substance may be a cosmetic growth-stimu- absorption during the first 20 min after applica- lating agent suitable for AGA treatment.
tion9.
Caffeine has been shown to counteract the inhi-bitory effect of testosterone in hair follicles andhas been identified as a stimulator of human hairgrowth in vitro, a fact which may have importantimpact on clinical management of AGA.
According to the experimental conditions adop-ted in our study, both products in study had avery good skin compatibility, after applicationunder normal conditions of use. Moreover, theshampoo containing caffeine showed a goodcosmetic efficacy in the treatment of male andro-genetic alopecia.
Compared to placebo at the end of the study thecontentment of the volunteers with Verum wassignificantly higher. Precisely, 84,8% of thevolunteers have been satisfied with Verum,while 36,4% of the volunteers have been satisfied with Placebo.
Moreover, the volunteers referred that the reduc-tion in the intensity of hair loss, thedecrease/normalization of the hair loss, thedecrease of the number of hair in the basin, theimprovement of the strength and thickness of thehair were significantly higher in the Verumgroup than in the Placebo group.
At the end of the study, significantly more sub-jects would like to continue with the Verumbecause it reduces the hair loss, than with thePlacebo.
Also the investigator confirmed the good cosme-tic efficacy of the shampoo containing caffeine.
Particularly, it has been noted that the improve-ment in the strength of the hair loss and thereduction of the progression of the balding weresignificantly higher in the Verum group than in Efficacy of a Cosmetic Caffeine Shampoo in Androgenetic Alopecia management. II Note References
1) Hamilton JB. (1951) Patterned loss of hair in man: types and incidence. Ann. NY Acad. Sci., 53:
2) Norwood OT. (1975) Male pattern baldness:classifi cation and incidence. South Med. J., 68(11):
3) Jamin C. (2002) Androgenetic alopecia. Ann. Dermatol. Venereol., 129 (5 Pt 2): 801-3
4) Whiting DA. (1993) Diagnostic and predictive value of horizontal sections of scalp biopsy spe-
cimens in male pattern androgenetic alopecia. J. Am. Acad. Dermatol., 28: 755–763.
5) Kligman AM. (1988) The comparative histopathology of male-pattern baldness and senescent
baldness. Clin. Dermatol., 6(4): 108–118.
6) Fischer TW, Hipler UC, Elsner P. (2007) Effect of caffeine and testosterone on the prolifera-
tion of human hair follicles in vitro. Int. J. Dermatol., 46: 27-35
7) Brandner JM, Behne MJ, Huesing B, Moll I. (2006) Caffeine improves barrier function in
male skin. Int. J. Cosmet. Sci., 28: 343-7.
8) Otberg N, Patzelt A, Rasulev U, Hagemeister T, Linscheid M, Sinkgraven R, et al. (2007)
The role of hair follicles in the percutaneous absorption of caffeine. Br. J. Clin. Pharmacol., 65:
488-92.
9) Otberg N, Teichmann A, Rasuljev U, Sinkgraven R, Sterry W, Lademann J. (2007)
Follicular penetration of topically applied caffeine via a shampoo formulation. Skin Pharmacol.
Physiol.,
20: 195-8.
10) Kren R, Ogushi S, Miyano T. (2004) Effect of caffeine on meiotic maturation of porcine oocy-
tes. Zygote, 12: 31-38.
Author Address:
Teresa SistoDepartment of DermatologyCatholic University of the Sacred Heart L.go Gemelli 8, 00168 Rome, ItalyE-mail: teresa-sisto@libero.it

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