EVALUATION OF EFFICACY, COSMETIC QUALITIES ANO TOLERABILITY OF A LOTION FOR HAIR PHYSIOLOGICAL REGROWTH ANO REINFORCEMENT

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Lenard Cellen' ' Cathlic University f Sacred Heart,Department f Dermatlgy, Rma, ltaly ' EVIC, ltaly Received: September, 2008.

1 J. Appl. Csmetl. 27, (July/September 2009) EVALUATION OF EFFICACY, COSMETIC QUALITIES ANO TOLERABILITY OF A LOTION FOR HAIR PHYSIOLOGICAL REGROWTH ANO REINFORCEMENT Carlina Bussletti', Maria Vittria Tlaini2, Lenard Cellen' ' Cathlic University f Sacred Heart,Department f Dermatlgy, Rma, ltaly ' EVIC, ltaly Received: September, Key wrds: Andrgenetic alpecia; Regrwth; Thickness; Summary The aspect f hair, bth fr men and wmen, is an imprtant element in characterizing the physical appearance f a persn, cntributing t criteria f beauty and yuth impsed by mdem sciety. Tday many principals, bth pharmaceutical and csmetic, are available, functinal fr hygiene and keeping healthy hair ; in particlar the fastest grwing sectr is the ne that wrks n preventin and treatment f hair lss, ne f the mst cmmn imperfectins f the Western ppulatin, bth male and frnaie. There are many frms f alpecia, mst f wich are acquired, while the few cngenita] frms are related t rare syndrmes. The mst cmmn frm f alpecia is andrgenetic (it represents abut 70% f ttal cases). The described study assessed the efficacy and tlerability f a csmetic ltin fr physilgical regrwth and increased thickness f hair. Given the results f the study, we can say that this ltin shwed a gd csmetic efficacy in facil i tating the physilgical regrwth f hair and prmte the increase in the thickness Riassunt L'aspett della capigliatura, sia per gli umini che per le dnne, è un element imprtante nel caratterizzare la fisicità della persna, cntribuend ai criteri di bellezza e givinezza impsti dalla scietà mderna. Ad ggi sn dispnibili mlti presidi, sia farmaceutici che csmetici, utilizzabili per l'igiene e la cnservazine in buna salute dei capelli; in particlare il settre maggirmente in 85

Evaluatin f Efficacy, Csmetic Qualities and Tlerabi/ity f a Ltin far Hair espansine è quell per la prevenzine e il trattament della caduta dei capelli, essend questa un degli inestetismi più diffusi

2 Evaluatin f Efficacy, Csmetic Qualities and Tlerabi/ity f a Ltin far Hair espansine è quell per la prevenzine e il trattament della caduta dei capelli, essend questa un degli inestetismi più diffusi nella pplazine ccidentale sia maschile che femminile. Esistn varie frme di alpecia, la grande maggiranza delle quali sn acquisite, mentre le pche frme cngenjte sn legate a sindrmi rare. La frma di alpecia più diffusa, (rappresenta il 70% circa del ttale dei casi) è quella andrgenetica. li trattament dell 'alpecia andrgenetica prevede, secnd gli stadi, l'us di farmaci specifici (minxidil, finasteride etc.) che slitamente vengn affiancati a trattamenti csmetici più men efficaci tra i quali il paziente si trva a scegliere, spess spint da pubblicità e infrmazini nn sempre crrette. L studi che descri viam ha valutat l'efficacia e la tllerabilità di una lzine csmetica per la ricrescita fisilgica e per l' aument dell spessre dei capelli. Sulla base dei risultati ttenuti nel crs dell studi è pssibile affermare che questa lzine ha dimstrat una buna efficacia csmetica nel cadiuvare la ricrescita fisilgica dei capelli e favrirne l'aument dell spessre. 86

Since ancient times, a lt f prducts fr hair health and wellness were frmulated, and csmetic industry in last years imprved in this field with increasingly specialized and diversified prducts t answer

Tday many principals, bth pharmaceutical and csmetic, are available, functinal fr hygiene and keeping healthy hair; in particular the fastest grwing sectr is the ne that wrks n preventin and

3 C. Buss/etti, M. V. Tlaini, L. Cellen INTRODUCTION The aspect f hair, bth fr men and wmen, is an imprtant element in characterizing the physical appearance f a persn, cntributing t criteria f beauty and yuth impsed by mdem sciety. Since ancient times, a lt f prducts fr hair health and wellness were frmulated, and csmetic industry in last years imprved in this field with increasingly specialized and diversified prducts t answer t specific needs f the cnsumer. Tday many principals, bth pharmaceutical and csmetic, are available, functinal fr hygiene and keeping healthy hair; in particular the fastest grwing sectr is the ne that wrks n preventin and treatment f hair lss, ne f the mst cmmn impe1fectins f the Western ppulatin, bth male and frnaie. There are many frms f alpecia, mst f which are acquired, while the few cngenita! frms are related t rare syndrmes. The mst cmmn frm f alpecia is andrgenetic (it represents abut 70% f tta! cases). It develps frm puberty, and it causes a diffuse hair lss with different phentype in the tw sexes - see Hamiltn and Ludwig classificatin in Fig. I and it recgnizes a hrmnal cause as well as a genetic predispsitin. Mre rare frms f alpecia are the alpecia areata, the scarring alpecia, the telgen effluvium, the alpecia caused by drugs, nutritinal deficiencies, surgical stress, endcrine, infectius, autimmune diseases. MATERIALS ANO METHODS Prduci In Study The described study assessed the efficacy and tlerability f a csmetic ltin fr physilgical regrwth and increased thickness f hair*. * 1"rade 11ame: Crescina Fr1e,Jrmula1ed by Lt1b Csprplrar AG Switzerlafld. 4, /:-. <Y L.;J I I y I,-. çte -- L' I,,_,,..,,.... I ì., m ' F " / I li \ '<. 'e' '"' - '...;. - le' ' /. : \. Il 1'. <Y ' ),,...,..._ - --) \( ", ;:.."\ y l... : ; m Hamiltn scale fr male alpecia - A ng V Ludwig scale fr frnaie alpecia Fig.l EXPERIMENTAL DESIGN This prduct has been tested n subjects f bth sexes aged between 35 and 60 years, suffering frm andrgenetic alpecia f the secnd degree f Hamiltn scale, and f the first and secnd degree f Ludwig scale fr wmen. The exami- 87

Evaluatin f Efficacy, Csmetic Qualities and Tlerability f a Ltin tr Hair ned subjects had nt skin diseases f the scalp, allergies r skin reacti vity that culd interfere with test results.

inclusin in the study, after 30, 60 and 90 days f treatment; - with the measurement f the diameter f the hair shaft, perfrmed n I O hair cut during phttrichgramma, perfrmed at time f inclusin, and

hair regrwlh The prduct induces an increase in the thickness f hair The prduci induces a reductin fhair lss The prduct induces a fasler regrwth f hair The prduct strengthens hair.

4 Evaluatin f Efficacy, Csmetic Qualities and Tlerability f a Ltin tr Hair ned subjects had nt skin diseases f the scalp, allergies r skin reacti vity that culd interfere with test results. The csmetic acti vity f the prduct has been avaluated: - with the technique f phttrichgramma, perfrmed at time f inclusin, after 60 and 90 days f treatment; - with pull-test, perfrmed at time f inclusin in the study, after 30, 60 and 90 days f treatment; - with the measurement f the diameter f the hair shaft, perfrmed n I O hair cut during phttrichgramma, perfrmed at time f inclusin, and after 90 days f treatment; - with a subjective evaluatin f vlunteers participating in the experimental s1udy, wh have expressed lheir pinin in relatin t the f llwing statements: The prduci prmtes new hair regrwlh The prduct induces an increase in the thickness f hair The prduci induces a reductin fhair lss The prduct induces a fasler regrwth f hair The prduct strengthens hair. Csmetic qualities have been tested: - with a subjective evaluatin f vlunteers parlicipating in the experimental study, wh have expressed their pinin, after 30, 60, 90 days f treatment, in relatin t the fllwing statements: The prduct has a pleasant smell The prduci is easy t apply The prduct des nt grease the hair the prduct des nt weigh the hair The prduct makes hair sft The prduct makes the hair easy t cmb. Cutaneus tlerability has been tested: - with dermatlgie cntr! at time f start, after 30, 60, e 90 days f treatment; - with subjecti ve evaluatin f vlunteers participating in the experimental study, wh have reprted any side effects in a daily diary prvided at time f inclusin. This study was perfrmed in single blind, the experimental cnditins adpted (skin test area, amunt f prduct applied, frequency and duratin f applicatin) ha ve reprduced the nrmai cnditins f use f the real treatment, and the pinin f vlunteers was cnsidered because it culd reflect the view f ptential cnsumers. In the 10 days befre the start f the study, vlunteers have used a delicate shamp withut specific activity ; this shamp has been used 2-3 times a week t wash the hair and scalp. In this perid the vlunteers have nt used ther prducts t wash their hair and scalp (shamp, ltins etc) The same delicate shamp was used during the 90 days f the study. The ltin was applied in the amunt f 3,5 ml, drp by drp, n sparse areas f the scalp, in the evening every ther day fr 90 cnsecutive days, withut washing the haij after applicatin f the prduct. Cncemed vlunteers did nt apply any ther csmelic prduci n hair and scalp, and they have nt changed their hygiene habits and were nt expsed t the sun r UVA rays during the perid f treatment. RESULTS With regard t csmetic activity f 1he ltin, results btained after 90 days with the technique f phttrichgramma shwed that this prduct induces an increase f 2,61 % f the tta! number f hair, an increase f 9,32% in the number f hair in the anagen phase (the grwth phase f hair), with 6,75% increase in the percentage f hair at this stage, and a decrease f 8,54% in the number f hairs in telgen phase, (the stage f hair lss), crrespnding t a reductin f 11,11 % as a percentage f hair in telgen phase (see graphs I, 2, 3, 4, 5). 88

l 41 M 111 vertex X 2 39 F I X 3 50 M LII X 4 53 M!

5 C. Buss/etti, M. V. Tlaini, L. Celle n EXPERIMENTAL PROCEDURE TAB.I Characteristics f the 25 vlunteers included in the study Age Sex Crrespndence t 'lì-ial inclusin and Alpecia degree exclusin criteria N. l 41 M 111 vertex X 2 39 F I X 3 50 M LII X 4 53 M!Ila X 5 46 F II X 6 39 F I X 7 56 M ila X 8 50 M III X 9 36 M li X F II X Il 45 M IJ1 vertex X F I X M Ila X M m a X F I X F II X F Il X M III X M III vertex X M II X F I X F II X F II X M!Ila X F II X Legend:!=n x=yes * accrding t Hamiltn scalefr men and Ludwig scalefr wmen 89

Evaluatin f Efficacy, Csmetic Qualities and

.r:. 199,44 E :J e: 201,24 204,64 195 1 90_,.

145... 140 J 36,08.r:. "' I 133,08 Q; 135.

6 Evaluatin f Efficacy, Csmetic Qualities and Tterability f a Ltin tr Hair "'... Cl) 200..r:. 199,44 E :J e: 201,24 204, _,. -T lo Graph 1: Cmplexive number f hair J 36,08.r:. "' I 133,08 Q; 135. E :J e: 130 I 124,48.e-= t Graph 2: Number f hair in anagen phase 90

e 75 E :i 71 e: 69 I I Il 68,16 68,56 67 65 IO

7 C. Buss/etti, M. V Tlaini, L. Cellen 79 77j 74:J6.t: "' 73 Q).e 75 E :i 71 e: 69 I I Il 68,16 68, IO t60 t90 Graph 3: Number f hair in telgen phase 70% I 66,15% F ,20%.t: "' Q) Cl! 6Q O/ e: Q) a. 55% - 50% ,., - IO t60 t90 Graph 4: Percentage f hair in anagen phase 91

Evaluatin f Efficacy. Csmetic Qualities and Tlerability f a Ltin tr Hair.

«-..-...---r to 160 190 Graph 5: Percentage f hair in telgen phase The pull-test shwed that the ltin induces a

hair extracted by this technique, indicating an increase in resistance t the levy in pull ing the hair.

8 Evaluatin f Efficacy. Csmetic Qualities and Tlerability f a Ltin tr Hair... 40% 38% J:: "' 36% Cli I 37,80% I I 33,85% l5' 33,60% e: 34% Cli. 32% « r to Graph 5: Percentage f hair in telgen phase The pull-test shwed that the ltin induces a decrease f 18,28% after 30 days, f 27,24% after 60 days and f 44,03% after 90 days f treatment, in the number f hair extracted by this technique, indicating an increase in resistance t the levy in pull ing the hair. The results are visible in the fllwing graph 6. 12, 10,72... J:: "' "O Cli i ;e Cli 6 Q; J:I E 4 ::J e 7,80 6,00 2 Q f-----,,.-..., '(' to Graph 6: Number f extracted hair 92

C. Buss/etti, M. V Tlaini, L. Cellen The measurement f the diameter f the hair shaft shwed that the prduct induces, after 90 days f treatment, an increase f 2,41 / f the diameter f hair shaft.

.. Q) ti E :e "' 57 56 55-1"--(' lo Graph 7: Diameter f hair shaft 190 In relatin t subjective evaluatin f csmetic acti vi ty, after 90 days f treatment, the 68% f vlunteers reprted that the prduct

9 C. Buss/etti, M. V Tlaini, L. Cellen The measurement f the diameter f the hair shaft shwed that the prduct induces, after 90 days f treatment, an increase f 2,41 / f the diameter f hair shaft. The results, expressed in mm, are represented in the fllwing graph Oi.i=... "' 59.i= "' 58 Q) '15 =... Q) ti E :e "' "--(' lo Graph 7: Diameter f hair shaft 190 In relatin t subjective evaluatin f csmetic acti vi ty, after 90 days f treatment, the 68% f vlunteers reprted that the prduct prmtes the regrwth f new hair and the same percentage reprted an increase in the thickness f hair. 80% f the vlunteers said that the ltin induces a reductin f hai r lss, and 72% f them said that it induces a faster hair regrwing. At last, 92% f subjects said that the ltin strengthens the hair. Fr each parameter, the percentage f satisfied vlunteers is represented in fllwing graph 8. 93

Evtutin f Efficcy, Csmetic Qutities nd Tterbitity f Ltin tr Hir 6 ti.!!!.!!! 10 1 80% 60% 4)! e: ::J > 40% n 80 % Fil 68 % 68 % 72% 92% 20% C k--1'<.

faster thickness f hair r hair lss regrwth f hair The prduci strengthens hair Abut the ltin csmetic qualities, after 90 days f treatment, 84% f vlunteers expressed satisfactin

Furthermre, 60% f subjects reprted that the prduct makes hair sft, 68% that it makes the hair easy t cmb.

10 Evtutin f Efficcy, Csmetic Qutities nd Tterbitity f Ltin tr Hir 6 ti.!!!.!!! % 60% 4)! e: ::J > 40% n 80 % Fil 68 % 68 % 72% 92% 20% C k--1'< The prduci prmtes new hair regrwth Graph 8: % f vlunteers satisfactin The prduct induces The prduci The prduci an increase in the ìnduces a reductin induces a faster thickness f hair r hair lss regrwth f hair The prduci strengthens hair Abut the ltin csmetic qualities, after 90 days f treatment, 84% f vlunteers expressed satisfactin abut the pleasantness f smell, 88% abut ease in appl icatin, 84% abut the fact that the prduct des nt grease the hair, 76% abut that it des nt weigh. Furthermre, 60% f subjects reprted that the prduct makes hair sft, 68% that it makes the hair easy t cmb. Abut each assertin, the percentage f satisfied vlunteers is represented in fllwing graph 9. Regard ing the cutaneus tlerabil ity f the ltin, there was n skin reactin due t the prduct cncerned at dermatlgie cntr! f the specialist, and n vlunteer reprted the appearance f side effects during the trial. 94

C. Buss/etti, M. V Tlaini, L. Cellen 100% 88% 84% 84% e:,!:! ca i (/) ai e: :i > 00% 00% 40% 20% 76% 6)% 68 % 0% The prcluct has a pleasant smeu -.

Graph 9: Percentage f vlunteers satisfactin CONCLUSIONS Given the results f the study, we can say that this csmetic ltin shwed a gd csmetic effi cacy in facilitating the physilgical regrwth f hair

Indeed, at the end f the study, it was nted an increase f the diameter f hair shaft, while the results f phttrichgramma shwed an increase in the nu mber f hair in anagen phase (+9,32%), and a

11 C. Buss/etti, M. V Tlaini, L. Cellen 100% 88% 84% 84% e:,!:! ca i (/) ai e: :i > 00% 00% 40% 20% 76% 6)% 68 % 0% The prcluct has a pleasant smeu The prduci is The prduci des The prduct des The prduct The prduci makes the easy t apply nt grease the hair nt weigh the hair makes hair sft hair easy 10 cmb. Graph 9: Percentage f vlunteers satisfactin CONCLUSIONS Given the results f the study, we can say that this csmetic ltin shwed a gd csmetic effi cacy in facilitating the physilgical regrwth f hair and prmte the increase in the thickness. Indeed, at the end f the study, it was nted an increase f the diameter f hair shaft, while the results f phttrichgramma shwed an increase in the nu mber f hair in anagen phase (+9,32%), and a decrease in the number f hair in telgen phase (-8,54%), indicating a gd activity f this prduce This activity was cnfirmed by the results f pull-test, that shwed an increase f resistance t the levy in pulling the hair. The vlunteers' pinin abut the csmetic efficacy cnfirmed this results; in particular the ltin was appreciated because it pr mtes new hair regrwth (rep1t ed by 68% f subjects), it induces an increase in the thickness f hair (reprted by 68%) and it strengthens hair (reprted by 92%). Furthermre the prduct was appreciated fr his csmetic qualities, especially fr his pleasant smell, because it is easy t apply and it des nt grease the hair. At last, under the experimental cnditins adpted in this tria!, n the basis f the dermatlgie cntr! and the subjecti ve evaluatin f vlunteers, this csmetic ltin shwed an excellent cutaneus tlerability. 95

Evaluatin f Efflcacy, Csmetic Qualifies and Tlerabi/ity f a Lfin tr Hair References 1) Sehgal VN, Aggarwal AK, Srivastava G, Rajput P. (2006) Male pattern andrgenetic alpecia. Skinmed, 5(3): 128-35.

r lss: current treatment cncepts. Clin. lnterv. Aging, 2(2): 189-99. 4) LinksOtberg N, Finner AM, Shapir J. (2007) Andrgenetic alpecia. Endcrin!. Metab. Clin. Nrth Am., 36(2): 379-98.

12 Evaluatin f Efflcacy, Csmetic Qualifies and Tlerabi/ity f a Lfin tr Hair References 1) Sehgal VN, Aggarwal AK, Srivastava G, Rajput P. (2006) Male pattern andrgenetic alpecia. Skinmed, 5(3): ) Passchier J, Erdman J, Hammiche F, Erdman RA. (2006) Andrgenetic alpecia: stress f discvery. Psychl. Rep., 98(1): ) Dinh QQ, Sinclair R. (2007) Female pattern hai.r lss: current treatment cncepts. Clin. lnterv. Aging, 2(2): ) LinksOtberg N, Finner AM, Shapir J. (2007) Andrgenetic alpecia. Endcrin!. Metab. Clin. Nrth Am., 36(2): ) Tsti A, Piraccini BM, lrizz M, Vuduris S. (2005) The natural histry f andrgenetic alpecia. J. Csmet. Dermatl., 4(1): Authr Address: Prf. Lenard Cellen Cathlic University f Sacred Heart Department f Dermatlgy Rma - ltaly lcellen@liber.it 96

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