CONFIDENTIAL REPORT

Rf : EC-MX01-BC-MS01
EVALUATION OF THE EFFICACY OF A HAIR GROWTH
ACCELERATION TREATMENT :
HAIR GROWTH KINETICS MEASUREMENT
SELF-EVALUATION QUESTIONNAIRES
REFERENCES OF THE TEST PRODUCTS :
S!"#$$ : %0& 1'0
A(()*)+!,$+ C$-./,/$--)+ : 001 120
I- 3/3$ ,)4, $- 4567)(,4
Study Sponsor:
B8C
BP 91'
01091 ROUBAIX C).): 01
SPINCONTROL ;5/**), 8001
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%'000 TOURS
CONTENTS
1@ TRIAL CONDITIONS 8
1.1. Site of experimentation 2
1.2. Study Sponsor 2
1.3. Study Monitor 2
1.4. Investigator 2
1.5. Scientific Manager & Study Director 2
1.. !ec"nician 2
1.#. $ua%ity &ssurance Manager 2
8@ STUDY SUMMARY %
2.1. '()ectives 3
2.2. Study *opu%ation 3
2.3. !ria% period+ ,inetics+ and sc"edu%e 3
2.4. Study Design 3
%@ METHODOLOGY &
3.1. Su()ect Se%ection 4
3.1.1. The inclusion, exclusion and restrictions criteria defined in the protocol are listed below 4
3.1.2. Non-inclusion criteria 5
3.1.3. Proscriptions and restrictions 5
3.2. *roduct *resentation 5
3.2.1. Product Application Frequency Methods
3.2.2. Tolerance
3.3. -"oice of tria%
3.4. .andomisation #
3.5. &ssessment met"ods #
3!" #rowth $inetics %easure%ent #
3!& 'elf-e(aluation )uestionnaires #
3.. /xamination sc"edu%e 0
3.#. *resentation of resu%ts 1
3*" #lobal results for the panel as a whole +
3*& ,ndi(idual results +
3*3 'tatistics +
&@ ETHICAL AND LEGAL CONSIDERATIONS 10
4.1. Study *ersonne% 12
4.2. &rc"iving of t"e data 12
4.3. Insurance 12
4.4. Dec%aration to t"e -3I4 12
4.5. &nonymity of t"e su()ects 12
4.. -onsent to participate in t"e study 11
4.#. -onfidentia%ity 11
4.0. $ua%ity of &ssurance 11
4.1. &nnex documents not direct%y re%ated to t"e study 12
0@ RESULTS 18
5.1. -omp%iance 5it" t"e protoco% 12
5.2. 6air gro5t" ,inetics measurement resu%ts 12
5.2.1. #lobal results -Annex ". 12
5.2.2. ,nterpreted results -Annex &. 13
5.3. Se%f7eva%uation resu%ts 8&nnex 39 14
5.4. -onc%usion 15
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1@ TRIAL CONDITIONS
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8@ STUDY SUMMARY
8@1@ O67)(,/3)4
!"e o()ective of t"is tria% 5as to assess t"e efficacy of a "air gro5t" acce%erator treatment.
!"is treatment 5as composed of a treatment s"ampoo and a conditioner identified under t"e
reference num(ers %isted (e%o5:
S"ampoo .ef.: 324 1#2
-onditioner .ef.: 521102
!"is assessment 5as performed using:
Se%f7eva%uation Guestionnaires ans5ered (y t"e test su()ectsH
&n ana%ysis of t"e "air gro5n rate.
!"e assessment 5as underta,en over a tota% period of 20 days of treatment app%ication.
8@8@ S,5.A P$#5*!,/$-
!"e test 5as carried out on 2 "ea%t"y su()ects. !"e individua%s recruited for t"is study 5ere
a%% 5omen.
!"ese su()ects "ad to strict%y meet t"e inc%usionIexc%usion criteria %isted in paragrap" 3.1.1.
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;roup 1: 32 su()ects 5"o app%ied no "air treatment at a%% 8-ontro% ;roup9
;roup 2: 32 su()ects 5"o app%ied t"e t5o products dai%y 8!reated group9
!"eir average age and "air type 8oi%y and dry9 5ere eGua%%y represented 5it"in t"e 2 groups.
8@%@ T+/!* #)+/$.? E/-),/(4? !-. 4().5*)
!"e tria%s (egan on &pri% 1# and 10+ 2221+ and 5ere conc%uded on May 15 and 1+ 2221.
Study ,inetics:
!2 !20 days
1# & 10 &pri%+ 2221 15 & 1 May+ 2221
7 6air (%eac"ing 7 6air samp%ing
7 Se%f7eva%uation
7 Guestionnaire
8@&@ S,5.A D)4/B-
- !"is study 5as an JopenK study.
- It 5as a comparative study+ i.e. t"e effects of t"e treatment o(served on ;roup2
8treated9 5ere compared to t"e natura% variations o(served on -ontro% ;roup 1.
- !"e su()ects did not serve as t"eir o5n contro% reference.
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%@ METHODOLOGIE
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S*I3-'3!.'4Ls test pane% 5as made up of su()ects 5"o "ad ans5ered a computer
Guestionnaire prior to se%ection a(out t"eir medica% "istory+ a%%ergies+ s,in care and cosmetics
"a(its+ as 5e%% as various administrative detai%s. !"e enro%ments 5ere underta,en (y a
%icenced (eautician.
!"e procedure used to recruit+ se%ect+ and inc%ude t"e su()ects+ 5"o free%y gave t"eir fu%%y7
informed consent to participate in t"is study+ 5as dra5n up to ensure c%ear and precise
information ena(%ing t"e %atter to appreciate t"e o()ect and conseGuence of t"eir consent.
!"is procedure inc%udes in particu%ar:
- & pre%iminary intervie5 "e%d to exp%ain t"e study o()ective and protoco%+ t"e study
sc"edu%e and+ as t"e case may (e+ t"e forms of compensation+ as 5e%% as any possi(%e
cosmetics (enefits to (e expected+ t"e constraints and potentia% ris,s %in,ed to t"e studyH
- !"e reading of a data s"eet t"at stipu%ates t"e essentia% features of t"e study to ena(%e t"e
su()ects to free%y decide 5"et"er to participate or not (ased on t"e proposed conditions+
and t"en sign t"is forms giving t"eir express+ informed consentH
- !"is consent ma,es it possi(%e inc%ude t"e su()ect for coverage (y t"e civi% %ia(i%ity
insurance po%icies ta,en out independent%y (y t"e study Sponsor and Investigator as soon
as t"e su()ects "as (een definitive%y admitted to participate in t"e study (y its coordinator.
!"e su()ects recruited for t"e study 5ere se%ected under t"e responsi(i%ity of t"e study
investigator and coordinator (ased on t"e inc%usionIexc%usion and proscriptionIrestriction
criteria %isted in t"is protoco%.
!"ere 5ere 2 su()ects recruited for t"is study.
!"e resu%ts presented cover t"e tota%ity of t"e su()ects on "and for t"e fina% assessment day
8!20 days9.
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#eneral/
6ea%t"y su()ectsH
&vai%a(%e for t"e entire duration of t"e studyH
Motivated to free%y participate in t"e studyH
3ot simu%taneous%y engaged in any ot"er testing 5it" or 5it"out a direct t"erapeutic
effectH
6aving no remaining effects from a prior cosmetic+ dermato%ogica% or medica% study at t"e
(eginning of t"e study invo%ving t"e sca%p or "airH
3ot "aving modified t"eir cosmetic "a(its 8s,in7care products+ c%eansers+ etc.9 in at %east
t"e past 15 daysH
&(%e to )ustify "aving a permanent addressH
&(%e to understand t"e Arenc" %anguage: i.e.+ Arenc"7spea,ing su()ects capa(%e of reading
and understanding t"e study documents and a(%e to fo%%o5 t"e exp%anations givenH
6aving t"e (enefit of socia% security medica% coverage.
'pecific to the study
Aema%eH
-aucasianH
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<et5een 10 and 42 years of ageH
?it" oi%y or dry "air 832 of eac" in t"e t5o 2 groups9H
?it" mid7%engt" "air of a dar, s"ade 8c"estnut+ (ro5n to (%ac,9H
?it" "ea%t"y s,in 8free of psoriasis+ ecMema+ eryt"ema+ edema+ scars+ or cancerous
%egions9 and particu%ar%y on t"e sca%pH
3eit"er pregnant nor nursing a (a(y for a %ast t"e past 3 mont"sH
3ot "aving c"anged t"eir contraception met"ods in t"e past t"ree mont"s and agreeing to
continue t"eir present met"od for t"e duration of t"e studyH
6aving a regu%ar cyc%e or ta,ing an ora% contraceptiveH
!a,ing no "ormona% treatments %in,ed to a "ea%t" condition 8e.g.+ t"yroid pro(%ems+ etc9H
6aving no s,in "ypersensitivity or a%%ergy to cosmetics+ and particu%ar%y to "air (%eac"ing
productsH
3ot suffering from atopic s,inH
3ot "aving underta,en any type of 5eig"t7%oss diet for at %ast t"e past t"ree mont"s and
not p%anning to do so during t"e studyH
&ccepting not to underta,en any =B sessions in an institute for t"e entire duration of t"e
studyH
&ccepting not to dry t"eir "air 5it" a "air dryerH
&ccepting not to co%our or (%eac" t"eir "air for t"e duration of t"e study.
%@1@8@ N$--/-(*54/$- (+/,)+/!
4ac,ing any inc%usion criteria %isted a(oveH
6aving fai%ed to "eed t"e provision of artic%e 4 22171# of t"e modified %a5 dated 22I12I00
pertaining to:
!"e pro"i(ition of ta,ing part simu%taneous%y in severa% (iomedica% studies 5it"out
direct individua% (enefitH
!"e period of Jnon inc%usionK during 5"ic" an individua% may not ta,e part in any
ot"er (iomedica% study 5it"out direct individua% (enefit.
<eing deprived of %i(erty due to a %ega% or administrative decision+ suffering from i%%ness
and in need of emergency care 8artic%e %221759H
<eing a minor or of age (ut under %ega% guardians"ip or institutiona% care+ insofar as t"e
study can (e underta,en in a different manner 8artic%e %22179.
Aai%ing to acGuiesce (y refusing to sign t"e express+ informed consent form.
%@1@% P+$4(+/#,/$-4 !-. R)4,+/(,/$-4
&pp%ication of any ot"er cosmetic product t"at tints+ (%eac"es+ or treats "air is proscri(edH
=se of anot"er s"ampoo (eside t"e one provided for t"e group app%ying t"e treatment is
proscri(ed. 8!"e su()ects in t"e contro% group can use t"eir usua% product+ 5it"out
s5itc"ing to anot"er+ for t"e duration of t"e study9H
!"e su()ects se%ected must under no circumstances "ave t"eir "air cut during t"e entire
study.
%@8@ P+$.5(, P+)4)-,!,/$-
!"e products under study 5ere provided (y t"e study sponsor. !"e products 8s"ampoo and
conditioner 5ere pac,aged in 252 m% (ott%es9.
!"e sponsor 5as responsi(%e for manufacturing+ pac,aging+ identifying+ and monitoring t"e
purity+ composition+ innocuousness+ and ot"er c"aracteristics of t"e products (eing tested.
!"e sponsor agreed to furnis" a certificate confirming t"e a(sence of any toxicity in t"e
products (eing tested.
S"ampoo .ef.: 324 1#2
-onditioner .ef.: 521102
Aor t"e purpose of t"is study+ t"e sponsor provided
!"e num(er of products necessary for t"e su()ects participating in t"e studyH
/noug" product for t"e additiona% su()ects ta,ing part in study.
'ne product per reference and one per (atc" for t"e Spincontro% companyLs samp%e
co%%ection.
!"e products 5ere stored a5ay from t"e %ig"t and at am(ient temperature.
%@8@1@ P+$.5(, A##*/(!,/$- > F+)F5)-(A > M),$.4
For the treated 0roup -0roup &.
!"e products 5ere app%ied dai%y+ morning or evening.
&pp%ication 5as underta,en (y t"e su()ects.
!"e treatment consisted in a pre%iminary "air 5as"ing using t"e s"ampoo provided. & t"ree7
to7four minute penetration period 5as t"en "eeded prior to rinsing.
!"e conditioner 5as app%ied even%y over t"e entire sca%p on 5et "air fo%%o5ing rinsing+ (eing
especia%%y carefu% to app%y t"e product rig"t do5n to t"e "air root. !"e rinsing 5as underta,en
at %east five minutes after product app%ication to guarantee its action. &%% of t"ese
recommendations 5ere stipu%ated in t"e data s"eet provided t"e su()ects 8See t"e protoco% in
annex9 at t"e start of t"e study+ as 5e%% as imparted ora%%y during t"e first assessment on !2.
For the control 0roup -0roup ".
!"e su()ects recruited for group 1 used t"eir usua% s"ampoo and at t"eir usua% interva%s
5it"out+ "o5ever+ (eing a%%o5ed to s5itc" (randsItypes for t"e entire duration of t"e study.
!"ey 5ere not permitted to app%y any "air care products.
%@8@8@ T$*)+!-()
!"e incidents t"at occurred during t"e course of t"e study 5ere %isted (y t"e study coordinator
in t"e study (inder. !"e nature+ severity+ date of appearance+ duration+ date of termination+
assessment+ and possi(%e treatments underta,en 5ere %isted in detai% in t"e o(servation
note(oo,+ a%ong 5it" t"e causes of t"e incidents o(served.
&%% serious undesira(%e effects 5ere reported to t"e study monitor 5it"in 40 "ours and
confirmed in 5riting 5it"in t"ree days.
%@%@ C$/() $f ,+/!*
!"is 5as an JopenK study in 5"ic" t"e investigator and t"e su()ects 5ere a%% a5are of
t"e nature of t"e products (eing tested.
!"is 5as a comparative study in 5"ic" t"e resu%ts o(tained (y t"e treated group
8group 29 5ere compared to t"e resu%ts o(tained (y t"e contro% group 8group 19.
!"e su()ects did not serve as t"eir o5n contro%.
%@&@ R!-.$"/4!,/$-
!"ere 5as no randomisation carried out. !"e su()ects se%ected 5ere divided into group 1
8contro%9 and group 2 8treated9 in suc" a 5ay so as to ensure t"at t"e t5o groups 5ere
"omogeneous+ (ot" in terms of age of "air type 8oi%yIdry9.
%@0@ A44)44")-, "),$.4
%@0@1@ G+$D, E/-),/(4 ")!45+)")-,
!"e o()ective 5as to Guantity t"e "air gro5t" ,inetics for (ot" t"e treated and for t"e contro%
group respective%y+ and t"en to compare t"em.
!o do so+ t"e tec"niGue consisted in measuring t"e %engt" of a samp%e of 12 "airs after 20 days
of treatment.
During the initial period prior to treatment: a strand of "air+ made up of a(out t"irty "airs
%ocated on t"e top of t"e sca%p+ 5as se%ected and a %engt" of t"is "air measuring t5o to t"ree
cm 5as (%eac"ed starting at t"e root. &s t"is (%eac"ing operation did not penetrate t"e "air
fo%%ic%e+ t"e "air 5as not p"ysio%ogica%%y distur(ed and its capacity for gro5t" 5as t"erefore
unaffected.
&fter app%ying t"e (%eac"ing product for 22 minutes+ it 5as t"en t"oroug"%y rinsed.
After 28 days of treatment: at %east 12 "airs from t"is strand 5ere pu%%ed out for samp%ing
purposes. !"e distance (et5een t"e root and t"e %imit of t"e (%eac"ed %engt" 5as t"en
measured on t"ese 12 samp%e "airs.
%@0@8@ S)*f-E3!*5!,/$- Q5)4,/$--!/+)4
& se%f eva%uation 5as a%so underta,en (y t"e group t"at "ad app%ied t"e treatment. In
agreement 5it" t"e sponsor+ t"e Guestionnaire 5as organised in t"e fo%%o5ing manner:
Questionnaire composition:
". 'pontaneous responses/ 1hat did you thin$ of the hair re(italisin0 and 0rowth
acceleratin0 treat%ent2 Positi(e points 3 Ne0ati(e points
&. 4os%etic appreciation of the products and assess%ent of treat%ent efficacy/
Possible responses to affir%ations -questions fro% " to "5./
6ntirely a0ree
A0ree
7o not entirely a0ree
7o not a0ree at all
$uestion 1: !"e s"ampooLs texture is p%easant.
$uestion 2: !"e conditionerLs texture is p%easant.
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C$-f/.)-,/!* D$(5")-,
$uestion 3: !"e scent of t"e products is p%easant.
$uestion 4: My "airLs appearance "as improved.
$uestion 5: My "air is s"inier.
$uestion : My "air is "ea%t"ier.
$uestion #: My "air Gua%ity "as improved.
$uestion 0: I noted t"at my "air gre5 faster.
$uestion 1: I t"oug"t t"e treatment 5as effective.
$uestion 12: I am satisfied 5it" t"e treatment.
$uestion 11: !"e fundamenta% nature of my "air sca%p "as not c"anged 8oi%y "air+ appearance
of dandruff+ etc.9. If JDo not entire%y agreeK or JDo not agree at a%%K exp%ain 5"y.
I 5ou%d (e prepared to continue t"e treatment. 8yesIno9
I 5ou%d (e prepared to purc"ase t"ese products. 8yesIno9
;%o(a% score attri(uted to t"e treatment 8s"ampoo and conditioner9 8nI129
!"ese documents 5ere dra5n up and processed using ScanL<ac sof5are 83SI company9. !"e
forms 5ere read 5it" t"e "e%p of a Au)itsu M321;: scanner and t"e same program. !"e data
5as t"en ana%ysed and presented using Microsoft /xce%.
%@9@ E:!"/-!,/$- 4().5*)
!"e effects of t"e treatment 5ere assessed over a 207day period. !"e measurment procedures
5ere as fo%%o5s:
On T0, the first day prior to product application:
4ocating of t"e "air strand to (e studiedH
<%eac"ing a 2 to 3 cm %engt" of t"e "air strand+ starting at t"e root.
Distri(ution of t"e products to t"e treatment group 8group29 and usage recommendations.
On day T28:
.apid Guestioning a(out t"eir to%erance to t"e productsH
Ai%%ing out of t"e se%f7eva%uation Guestionnaire (y t"e su()ects 8group 29H
4ocating of t"e (%eac"ed "air strandH
*u%%ing out a minimum of 12 "airsH
Measurement of t"e %engt" of t"e samp%esH
!ermination of t"e study.
-omment: !"e Guestionnaire 5as fi%%ed in (y t"e su()ect prior to ta,ing t"e "air samp%es so
t"at t"e %atter 5ou%d not inf%uence t"eir )udgement a(out t"e treatment.
Measurement Dates: 7 !2 &pri% 1# and 10+ 2221
- day !20: May 15 and 1+ 2221
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EC- MX01-BC-MS01-EC-RA-<V01=
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C$-f/.)-,/!* D$(5")-,
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!5o type of presentation 5ere made:
7 g%o(a%: corresponding to t"e average va%ues for t"e entire test pane% and
expressed in t"e form of ta(%es.
7 per su()ect: summary given a ta(%e of t"e a%% t"e va%ues measured during t"e
examinations.
%@'@1@ G*$6!* +)45*,4 f$+ ,) #!-)* !4 ! D$*)
!"is presentation ena(%es a rapid and overa%% visua%isation of t"e evo%ution in t"e parameters
under study.
!"ese g%o(a% resu%ts are presented for t"e su()ects as a 5"o%e on t"e fina% day of measuring at
day !20.
!"e g%o(a% resu%ts s"o5 t"e "air gro5t" ,inetics of t"e treated group and t"e contro% group as
5e%% as t"e differentia% (et5een t"em. !"is differentia% is a%so expressed in terms of
percentage in re%ation to t"e untreated contro% group 8group 19.
%@'@8@ I-./3/.5!* +)45*,4
Aor eac" su()ect+ t"e overa%% gross %engt" measurement+ t"e average va%ue of t"e 12 samp%es+
and t"e dispersion 8standard deviation9 are presented.
%@'@%@ S,!,/4,/(4
Instrumental techniques
!"e significance of t"e resu%ts 5as assessed using t"e StudentLs t7test for non7paired groups
8su()ect to app%ication conditions (eing verified9. !"e test 5as app%ied to t"e JgrossK va%ues of
measured "air %engt"s.
!"e accepta(i%ity t"res"o%d 5as set at 5 N
elf!e"aluation
AreGuency7 c"arts 5ere dra5n up to present t"e resu%ts of t"e Gua%itative Guestions (y ta,ing a
census of t"e num(er of vo%unteers and (y ta%%ying t"e freGuency of t"e various possi(%e
responses 8expressed as a percentage9. !"e responses o(tained for eac" Guestion 5ere t"en
recorded in ta(u%ar form 8individua%s and freGuencies9. !"e statistica% difference in t"e
freGuencies 8N9 5as eva%uated using a c"i7sGuare test. &s for t"e responses t"at corresponded
to agreement or disagreement+ t"e 4 different responses 5ere grouped into t5o categories as
s"o5 (e%o5:
&;.//
A0ree entirely
A0ree
D' 3'! &;.//
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
7o not A0ree entirely
7isa0ree
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
&@ ETHICAL AND LEGAL CONSIDERATIONS
&@1@ S,5.A P)+4$--)*
!"e investigator guaranteed t"at a%% t"e individua%s ta,ing part in t"e tria% "ad t"e reGuired
Gua%ifications and s,i%%s to adeGuate%y perform t"e diverse measurements.
&@8@ A+(/3/-B $f ,) .!,!
Dua% arc"iving 5as underta,en using t5o different media: paper documents and e%ectronic
data fi%es. !"e paper fi%es are arc"ived in a %oc,ed ca(inet+ c%ose to an extinguis"er. !"e
e%ectronic data7a stored on D&! cassettes and ,ept for a 127years period.
!"e investigator retained a copy of t"e protoco% signed (y t"e study sponsor and (y "imse%f+
as 5e%% as t"e origina% Jo(servation recordsK 8and a%% documents used to dra5 t"em up9+ t"e
participation consents+ and documents of any sort re%ated to t"e pro)ect for a 127years period.
&%% documents are accessi(%e for inspection (y t"e study sponsor on "is reGuest. &%% e%ements
are retained for a 127years period as of t"e de%ivery date of t"e fina% report and t"ey are
avai%a(%e for inspection after reasona(%e notification (y eit"er a representative aut"orised (y
t"e study sponsor or (y study supervision aut"orities. !"e investigator 5i%% inform t"e study
sponsor 5"en t"e data is to destroyed fo%%o5ing t"e 127years period.
&@%@ I-45+!-()
!"e investigator and t"e study sponsor (ot" too, out an insurance po%icy covering t"eir civi%
%ia(i%ity 5it" regard to t"e su()ects.
!"e study Sponsor too, out an insurance po%icy covering potentia% %ia(i%ity resu%ting from t"e
test pro)ect 5it" t"e AXA ($"#!-A+ po%icy -G 1%8@1%1@80@0&@
!"e study Investigator too, out an insurance po%icy covering "is civi% %ia(i%ity 5it" t"e AXA
($"#!-A? #$*/(A -G '1@111@00&@
&@&@ D)(*!+!,/$- ,$ ,) CNIL
In accordance 5it" t"e %a5 covering JInformation tec"no%ogy and freedomK dated Fanuary
t"
+
11#0 t"e data(ase needed to underta,e a%% t"e studies carried out (y Spincontro% "ad (een
dec%ared to t"e -3I4.
&@0@ A-$-A"/,A $f ,) 4567)(,4
!"e su()ects 5ere identified for t"e study sponsor (y an a%p"anumeric code 5it" five
c"aracters and (y a num(er. & confidentia% computerised %ist+ 5it" t"e names and addresses of
t"e vo%unteers+ is ,ept at Spincontro% "eadGuarters.
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
&@9@ C$-4)-, ,$ #!+,/(/#!,) /- ,) 4,5.A
&n information s"eet 5as given to eac" su()ect providing fu%% detai%s a(out:
- t"e study o()ectives+ met"ods+ and durationH
- t"e expected (enefits+ constraints and potentia% ris,s of t"e test 8particu%ar%y in case
of study discontinuation9H
7 t"e non7inc%usion period+ t"e amount of t"e compensation+ t"e rig"t of access to
data fi%es+ and t"eir su(seGuent destruction.
&@'@ C$-f/.)-,/!*/,A
&%% information+ data and resu%ts of t"e study are confidentia%. &%% persons "aving access to
suc" data 5ere informed t"at t"ey are confidentia%.
Medica% information concerning t"e su()ects o(tained (y t"e investigator during t"e
recruitment and admission 5as "and%ed confidentia%%y in comp%iance 5it" artic%e 22713 and
t"e fo%%o5ing of t"e *ena% -ode+ as 5e%% as 5it" t"e medica% professionLs code of et"ics
8decree nO 1571222+ Decem(er+ 11159.
Identifia(%e information of a private nature 5as not imparted to t"e study sponsor.
J!"e investigator and a%% persons conducting t"e testing are (ound (y professiona% secrecy
concerning t"e nature of t"e products studied+ t"e tria%s+ t"e vo%unteers+ and t"e fina% resu%tsK
8excerpt from &rtic%e . 5122 of Decree nO 1270#2 dated Septem(er 1112+ under modified %a5
nO 0071130 dated Decem(er 22+ 1100+ regarding t"e protection of "uman (iomedica% researc"
su()ects: 6uriet %a59.
&@2@ Q5!*/,A A445+!-()
!"e study 5as su()ected to Gua%ity assurance procedures in comp%iance 5it" regu%atory
recommendations. !"e protoco% and data 5ere verified a%ong 5it" t"e specific procedures.
!"e fina% report 5as revie5ed to ensure t"at it accurate%y descri(es t"e met"ods and
procedures+ and t"at t"e resu%ts accurate%y ref%ected t"e ra5 data. Berifications of t"e data
generated in t"is study 5ere performed in accordance 5it" 8Proc9dure des Proc9dures:
8procedure accomp%is"ment9 nO *./7&S$71.
!"e fina% report 5as issued fo%%o5ing a $ua%ity &ssurance eva%uation of t"e comp%eted draft
report. !"is report inc%udes a%% study detai%s+ a%ong 5it" to fo%%o5ing additions:
!"e signature of t"e Investigator and t"e Study Director aut"enticating t"e report.
& statement certifying t"at t"e report "as (een su()ected to a $ua%ity &ssurance
/va%uation signed (y t"e Gua%ity assurance manager.
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
&@1@ A--): .$(5")-,4 -$, ./+)(,*A +)*!,). ,$ ,) 4,5.A
!"e documents inc%uded in annex 5 correspond to an ear%ier study carried out (y t"e <I'D/B
%a(oratory 8A70#222 4imoges9 5"ic" "as not direct %in, to t"e Spincontro% company. !"e
Spincontro% company %eaves t"e entire responsi(i%ity for its contents to t"is studyLs
Investigator.
0@ RESULTS
0@1@ C$"#*/!-() D/, ,) #+$,$($*
!"e protoco% 5as "eeded as a 5"o%e. !"e su()ects app%ied t"e product in a regu%ar fas"ion. &%%
t"e "air (%eac"ing procedures carried out on !2 and t"e "air samp%es o(tained 20 days %ater
too, p%ace under t"e conditions anticipated in t"e protoco% and 5it"out any tec"nica%
pro(%ems.
#omogeneity of the groups
?"ere t"e "omogeneity of t"e t5o groups is concerned+ t"eir age 5as statistica%%y identica%
(ot" in t"e JtreatedK and t"e Jcontro%K group+ 5it" a respective average of 2.2 and 2.4 years
of age.
.epresentativeness in terms of eit"er Joi%yK or JdryK "air 5as virtua%%y eGuiva%ent in (ot"
groups 8fig. 19.
Bilateral t test Significant
Homogeneity of the panel at T0 P(t) difference 5% ?
Age - eference gro!p "ers!s treated #$%&'-0( )o
)om*re de s!+ets
)!m*er of s!*+ects ,ith oily hail - treated (5
)!m*er of s!*+ects ,ith dry hail - treated (.
)!m*er of s!*+ects ,ith oily hail - eference (5
)!m*er of s!*+ects ,ith dry hail - eference (/
$igure %: #omogeneity of the &treated' and the &control' groups (ith respect to
the nature of the hair and a"erage age of the su)*ects+
,um)er of su)*ects
&t t"e conc%usion of t"e study+ t"e num(er of su()ects in t"e JtreatedK and in t"e Jcontro%K
group 5as+ respective%y+ 21 and 32. In t"e JtreatedK group+ t"e su()ect identified as S'=B&
5as exc%uded from t"e tria% for non7comp%iance 5it" t"e protoco% (ecause s"e (ecame
pregnant during t"e study.
0@8@ H!/+ B+$D, E/-),/(4 ")!45+)")-, +)45*,4
0@8@1@ G*$6!* +)45*,4 <!--): 1=
!"e "air7gro5t" %engt" measurements 5ere carried iut on samp%es "aving a minimum of 12
"airs for eac" su()ects+ as s"o5n in figure 2.
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
$igure 2: Description of the length measurements carried out on the hair samples after 28 days of treatment -the
ordinate scale is in mm.+
!"ese measurements made it possi(%e to s"o5 t"at "air gro5t" ,inetics in t"e contro% group
amounted to 14.# P1. mm.
&t t"e same time+ t"e "air gro5t" in t"e treated group appeared to (e some5"at superior (y
2.5 mm at it amounted to 15.2 P1.0 mm. !"e difference (et5een t"e t5o groups is not
statistica%%y verified -p-t.;55!.
!"e "air gro5t" ,inetics in t"e su(groups Jdry "air treatedK and Joi%y "air treatedK compared
to t"at of t"eir eGuiva%ent in t"e contro% group does not s"o5 any statistica%%y significant
difference -p-t.;55!.
!"e su()ect M&.-1 s"o5s t"e greatest effect o(served in t"e JtreatedK group+ ac"ieving a
gro5t" of 10.1 mm in 20 days of treatment. -ompared to t"e average va%ue o(tained (y t"e
contro% group 814.# mm9+ t"is su()ect presented a "air gro5t" rate t"at is 23N "ig"er. !"is
maximum effect o(served is on%y indicative and is not intended to (e representative of t"e
efficacy o(served for t"e pane% as a 5"o%e.
0@8@8@ I-,)+#+),). +)45*,4 <A--): 8=
<eyond t"e gross resu%ts o(tained for t"e pane% as a 5"o%e+ and as is s"o5n in figure 3+ it
appears t"at t"e gro5t" ,inetics are superior in t"e group of su()ects 5"o app%ied t"e
treatment in re%ation to untreated group.
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
#air gro(th in 28 days
/leaching at T0
0ro(th limits at 28 days
$igure 1:2omparaison of the hair gro(th 3inetics of the su)*ects in the &treated' group and in the &control' group+
orted )y ascending order of gro(th rate+
!"is o(servation ena(%es s"o5ing t"at 12 4567)(,4 in t"e JtreatedK group+ or 98@1 H+ s"o5ed
a "air B+$D, +!,) 81.3 mm9 45#)+/$+ 6A '@1H fo%%o5ing t"e 20 days compared to t"at
o(served on average in t"e Jcontro%K group su()ects 814.# mm9. !"is difference appears to (e
4,!,/4,/(!**A 4/B-/f/(!-, after 20 days of treatment -p-t.<5555*= si0nificant at !>.
0@%@ S)*f-)3!*5!,/$- +)45*,4 <A--): %=
!"e product eva%uation Guestionnaire 8s"ampoo and conditioner9 su(mitted to t"e vo%unteers
5"o "ad app%ied t"e product during t"e 207days period s"o5s a genuine appreciation for t"e
products as muc" for t"eir cosmetic c"aracteristics as for t"eir effectiveness.
2osmetic characteristics
!"e responses concerning t"e cosmetic c"aracteristics as a 5"o%e are in t"e ma)ority and
significant%y positive. !"e satisfaction fe%t (y t"e su()ects 5it" regard to t"e "edonistic factors
5ere (ro,en do5n as fo%%o5s:
Ces Significant at 5NQ
!"e s"ampoo texture is p%easant: 91H Y)4
!"e conditioner texture is p%easant: 91H Y)4
!"e s"ampoo scent is p%easant: '8H Y)4
!"e conditioner scent is p%easant: '9H Y)4
Treatment efficacy
!"e g%o(a% efficacy of t"e treatment as a 5"o%e 8s"ampoo D conditioner9 5as recognised (y
t"e ma)ority of t"e su()ects and in a significant fas"ion as s"o5n (e%o5:
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
Ces Significant at 5NQ
6air appearance improved: 99H Y)4
6air s"inier: 98H Y)4
6air "ea%t"ier: 2%H Y)4
6air Gua%ity improved: 99H Y)4
6air gro5s faster: '9H Y)4
6air gro5t" acce%eration effectiveness: '1H Y)4
0lo)al satisfaction
!"e vast ma)ority of t"e su()ects 5"o used t"e products are prepared to continue t"e treatment
and purc"ase it. !"e average score attri(uted to t"e treatment is #.5I12
Ces Significant at 5NQ
?i%% you continue t"e treatmentQ: 1%H Y)4
?i%% you purc"ase t"e treatmentQ: 99H Y)4
pontaneous comments -positi"e and negati"e points concerning the products.
;%o(a%%y and in a non7ex"austive 5ay+ t"e positive and negative points made (y t"e su()ects
5ere:
Positi(e Points
!"e conditionerLs p%easant scent 813N9
!"e s"ampooLs Gua%ity 8#N9
!"e treatmentLs efficacy 8N9
T) !/+I4 /"#+$3). !##)!+!-() <11H=
!"ese spontaneous comments as a 5"o%e confirm t"e g%o(a% appreciation of t"e treatment
descri(ed in t"e Guestionnaire and presented a(ove.
&t t"e same time+ a fe5 negative points 5ere made spontaneous%y:
Ne0ati(e points
!"e s"ampooLs scent is not appreciated 85N9
!"e s"ampoo is too %iGuid 85N9
!"e conditioner ma,es t"e "air oi%y+ it doesnLt untang%e "air enoug"R 813N9
0@&@ C$-(*54/$-
!"e treatment+ tested for a 207day period (y 21 su()ects and compared to a contro% group of
32 su()ects 5"o did not app%y t"e products+ made it possi(%e to s"o5 4/B-/f/(!-,*A
!(()*)+!,). !/+ B+$D, E/-),/(4 $f '@1H f$+ 98H $f ,) 4567)(,4@
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
!"e maximum effect o(served on t"e group of treated su()ects amounted to 10.1 mm in 20
days+ eGuiva%ent to a gro5t" rate 23N a(ove t"e average va%ue o(tained (y t"e contro% group
8t"is is indicative information t"at is not representative of t"e efficacy o(served on t"e pane%
as a 5"o%e9.
&t t"e same time+ '1H of t"e su()ects Guestioned recognised t"at t"eir "ad gro5n at an
acce%erated rate after 20 days of treatment -si0nificant/ p-t.?55!.+ 5"i%e 1%H of t"em 5ou%d
(e prepared to continue using it -si0nificant/ p-t.?55!.
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
ANNEX 1:
GLOBAL RESULTS
GROWTH KINETICS MEASUREMENTS
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
Code Nof subject Age
Average
of length
Standard
Error
(SE)
Code Nof subject Age
Average
of length
Standard
Error
(SE)
BARFL 3 !" 3#! !#$ A%&LA '3 3" (#3 '#'
BEL)A "' 3* 3#! #$ B+,)' '! !* "#" !#(
C&AAL "* !( *#- !#* CANS+ " !" "#( 3#-
C&AC$ ( !. 3#! #- C&AA, !! $#" '#
C&ECE 33 !. $#( '# C&+CA !( 3 $#* '#!
C,/S% " !' '#! 3#( CRES+ !- !' (#" '#$
0E&12 . !' 3# (#* 0A1N3 ". 3. $#' "#.
0ELCL 3 3$ "#- (#" ELAF+ !! !- 3#$ $#"
0RESE - - '#' "#' 1,E)3 ' !! $#. $#*
&ALA1 ! !3 "#- "#' &ENFL 3- 3* '#" '#3
4EREN $ 3' 3#- $#' LE1S+ 3 !3 $#! 3#3
LEBFL 3' . !#" '#- LE%5A "! ! (#- .#(
)ARC- '. !! .#3 $#" 6ERN+ " !* "#. "#(
)ARS% !3 !! $#* 3#' 63%3S 3( "#3 3#*
/ERS '( !! $#. 3#* S+,/A ABS ABS ABS ABS
!'#$ "#' !$#- '#.
'#! !#* $#3 #3
Code Nof subject Age
Average
of length
Standard
Error
(SE)
Code Nof subject Age
Average
of length
Standard
Error
(SE)
ALBEL "( 3! $#$ "#$ BARA, $* 3! '#( !#!
BR3A 3* ! '#- '#' BEAC !* !3 !#3 #.
0A/0E $! !. '#. 3#- BE&AN !' 3! !#- #"
0+))A !" 3' '#( "#( C&+NA $ 33 3#' !#-
13R) "" ! $#* $#( C+7,3S ' 3" 3# !#!
&A0S+ $ !* 3#- 3# 0R+SA ' !" $#' *#-
)A3FR !$ 33 "#! 3#! ES%8 , !. ! "#" !#3
)ERES "$ !( "#' #- E%CC& ! "* "#( #$
7,3LA '$ 3* "#- !#* 13LEL '* ! .#* #3
R3CA1 3! !. 3#3 !#- &AS& '' . (#$ #$
R+BA ! !3 3#$ #" &ESAN ( ! '#$ 3#.
R+,BL * !$ 3#- #. LA&FA . 3 !#" #'
R+,C& - - !#. !#! LA&NA 3( !( $#* #.
R+,L 3. ! 3#! !#* LEBC& "3 3! #' !#"
SASA, '" !. 3#' !#$ N3RES 3" ! $#! 3#3
!$# "#' 63CCE '- !* $#* #$
'# #! /ENA0 "- !3 $#' *#.
!$#$ '#*
$#3 #3
1lobal Results Average of length SE
%reated grou9 #.
Reference grou9 #$
' subjects %reated grou9 dr: ha;r
EC-MX01-BC-MS01
Length measurements carried out on the hair samples after 28 days of treatment
MEAN
( subjects
" subjects
MEAN
Standard Error
MEAN
Standard Error
%reated grou9 o;l: ha;r
Reference grou9 o;l: ha;r ' subjects Reference grou9 dr: ha;r
MEAN
'#!
"#(
Standard Error
Standard Error
EC-MX01-BC-MS01
L)-B, ")!45+)")-,4 (!++/). $5, ,) !/+ 4!"#*)4 !f,)+ 82 .!A4 $f ,+)!,")-,
S,!,/4,/(4
Bilateral t test Significant
Homogeneity of the panel at T0 P(t) difference 5% ?
Age - eference gro!p "ers!s treated #$%&'-0( )o
)om*re de s!+ets
)!m*er of s!*+ects ,ith oily hail - treated (5
)!m*er of s!*+ects ,ith dry hail - treated (.
)!m*er of s!*+ects ,ith oily hail - eference (5
)!m*er of s!*+ects ,ith dry hail - eference (/
Bilateral t test Significant
'fficacy of the treatment P(t) difference 5% ?
Treated gro!p "ers!s reference gro!p 5$/5'-0& )0
0ily hair 1 Treated gro!p "ers!s eference gro!p .$#%'-0( )0
2ry hair 1 Treated gro!p "ers!s eference gro!p 3$/&'-0& )0
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
ANNEX 8:
INTERPRETED RESULTS
GROWTH KINETICS MEASUREMENTS
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
EC-MX01-BC-MS01
SU;ETS TRAITES PRESENTANT UNE CINETIQUE
DE POUSSE DES CHEVEUX SUPERIEURE A LA VALEUR DE REFERENCE
21 S3um(er of treated su()ects
10 S3um(er of o(served improvements re%ated to t"e mean va%ues o(served on reference group 8T14.# H red va%ue9
1.3 S&verage of "air gro5t" in 20 days 810 su()ects9
#.1N SIn crease in N of "air gro5t" re%ated to reference group 810 su()ects9
98@1H SN of su()ects presenting a superior "air gro5t" compared to t"e reference group
2.222# SStatistica% signification > <i%atera% t test > Significant S Ces at 5N
S#/-($-,+$*-B8C EC-MX01-BC-MS01-EC-RA-<V01=
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120 C$-f/.)-,/!* D$(5")-,
C$-f/.)-,/!* D$(5")-,
!./&!/D ./A/./3-/ DIAA/./3-/S
13.2 1. 3.4
13.2 15.1 2.#
12.1 15.0 5.2
13.2 15.# 2.
1.# 1.2 72.#
15.2 13.1 71.3
13.1 14.2 1.2
14.1 14.5 72.5
15.5 14.1 72.
14.1 13.3 71.
13.1 13. 72.4
12.4 13.1 1.5
10.3 12.0 75.5
1.2 13.2 72.1
1.0 13.5 73.2
1#.3 15.# 71.
14.4 12.3 72.1
14.# 12.1 71.0
1.4 13.5 73.2
1.2 13.1 72.0
1#.4 1.5 72.1
1.5 14.4 72.1
13. 14.# 1.2
1.0 10.2 1.2
15.4 1#. 2.3
1.2 15. 72.
1#.1 12.4 75.4
14.0 1.2 1.2
14.3 11.5 72.#
1.2
1.2
1.5
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ANNEX %:
RESULTS
SELF > EVALUATION
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EC-MX01-BC-MS01
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7uest;onn.
&a;r
health;er
7uest;on n- &a;r 7ual;t:
7uest;on
n*
&a;r 1ro<th
Faster
7uest;on
n
&a;r 1ro<th
accelerat;on
e=ect;vness
7uest;on
n!
Sat;sfact;on
7uest;on
n3
No
alterat;on
of the s>;n
Nu?ber @ Nu?ber @ Nu?ber @ Nu?ber @ Nu?ber @ Nu?ber @
Nb of ans<er !- !- !- !- !- !-
Agree !" .3@ - $$@ !! ($@ !3 (-@ !' .$@ !* $-@
0;sagree ' (@ * 3"@ ( !"@ $ !@ " "@ - 3@
(#3'EA*' 5es #'!EA*! 5es (#"3EA*" 5es !#"EA*" 5es !#*-EA*' 5es '#.'EA*3 5es
7uest;on
n'
2;ll :ou
cont;nue
the
%reat?ent
B
7uest;on
n$
2;ll :ou
9urchase the
treat?entB
7uest;on
n(
Score
Nb of ans<er Nu?ber @ Nu?ber @ %otal ans<ers !-
Agree !- !- Score C' !(
0;sagree !( -3@ - $$@ Score D' !
! (@ * 3"@ )ean (#".
#"*EA*$ Yes #'!EA*! Yes Standard Error #'*
T4D5 : 62!780%!/2!70%
DESCRIPTION OF TRIAL :
EVALUATION OF THE EFFICACY OF A HAIR GROWTH ACCELERATION TREATMENT BY:
- HAIR GROWTH KINETICS MEASUREMENT
- SELF-EVALUATION QUESTIONNAIRES
3um(er of su()ects : ;roup 1: 32 su()ects 5"o app%ied no "air treatment at a%% 8-ontro% group9
;roup 2: 32 su()ects 5"o app%ied t"e t5o products dai%y 8!reated group9
@inetics : !2 > !20 )ours
*rincipa% criteria for recruitment: !"eir average age and "air type 8oi%y and dry9 5ere eGua%%y
represented 5it"in t"e 2 groups. <et5een 10 and 42 years of age.
Measurement Dates: 7 !2: &pri% 1# and 10+ 2221
7 day !20: May 15 and 1+ 2221
PRODUCTS > TRIAL MODALITIES :
S"ampoo .ef.: 324 1#2
-onditioner .ef.: 521 102
&pp%ication freGuency : Dai%y
-"oice of tria% : 7 J'penK
7 -omparative study : !reated group compared to reference group
7 !"e su()ects did not serve as t"eir o5n contro%
METHODOLOGY :
T0 T82 .!A4
<%eac"ing of "airs 4
=prooting of "airs 4
&uto7eva%uation Guestionnaire 4
!"e o()ective 5as to Guantify t"e "air gro5t" ,inetics for (ot" t"e treated and for t"e contro% group respective%y+
and t"en to compare t"em.
RESULTS AND CONCLUSION :
!"e treatment+ tested for a 207day period (y 21 su()ects and compared to a contro% group of 32 su()ects 5"o did
not app%y t"e products+ made it possi(%e to s"o5 4/B-/f/(!-,*A !(()*)+!,). !/+ B+$D, E/-),/(4 $f '@1H f$+
98H $f ,) 4567)(,4.
!"e maximum effect o(served on t"e group of treated su()ects amounted to 10.1 mm in 20 days+ eGuiva%ent to a
gro5t" rate 23N a(ove t"e average va%ue o(tained (y t"e contro% group 8t"is is indicative information t"at is not
representative of t"e efficacy o(served on t"e pane% as a 5"o%e9.
&t t"e same time+ '1H of t"e su()ects Guestioned recogniMed t"at t"eir "air "ad gro5n at an acce%erated rate
after 20 days of treatment -si0nificant/ p-t.?55!.+ 5"i%e 1%H of t"em 5ou%d (e prepared to continue using it
-si0nificant/ p-t.?55!..
S#/-($-,+$*-B8C
EC- MX01-BC-MS01-EC-RA-<V01=
P+$.5(,4: S!"#$$ %0& 1'0 > C$-./,/$-)+ 001120
C$-f/.)-,/!* D$(5")-,