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Lactic Acid

Phase 3

Hygiene | Small molecule | Other |Sanofi|Last Updated: Jan 4, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials30
Total Enrollment1,458
FDA Designations
No designations recorded
Clinical Trials (30)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01158365Dermacyd in Odor Reducing.PHASE3 COMPLETED 230 — — Jul 1, 2010Dec 1, 2010Jan 4, 20111 Brazil
NCT00933946Dermacyd Silver Frutal (Lactic Acid) - Compatibility.PHASE3 COMPLETED 55 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00933907Dermacyd PH_DESILSTY_FR (Lactic Acid) - Compatibility - Stay on FrutalPHASE3 COMPLETED 55 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00933842Dermacyd PH_DESILSTY_FL (Lactic Acid) - Photo Evaluation - Stay on FloralPHASE3 COMPLETED 27 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00933712Dermacyd Silver Floral (Lactic Acid) - Compatibility.PHASE3 COMPLETED 55 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00933699Dermacyd PH_DESILSTY_FL (Lactic Acid) - Acceptability - Stay on Floral.PHASE3 COMPLETED 32 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00933569Dermacyd Silver Floral (Lactic Acid) - Acceptability.PHASE3 COMPLETED 31 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00933504Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on FloralPHASE3 COMPLETED 55 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00933413Dermacyd Silver Frutal (Lactic Acid) - Acceptability.PHASE3 COMPLETED 30 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00933257Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on FrutalPHASE3 COMPLETED 27 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00933075Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.PHASE3 COMPLETED 27 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00932984Dermacyd Silver Floral (Lactic Acid) - Photo EvaluationPHASE3 COMPLETED 27 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00932945Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on FrutalPHASE3 COMPLETED 32 — — Jun 1, 2009Jul 1, 2009Sep 14, 20101 Brazil
NCT00784121Dermacyd Breeze (Lactic Acid) Pocket BR - CompatibilityPHASE3 COMPLETED 54 — — Oct 1, 2008 -Dec 19, 20081 Brazil
NCT00784069Dermacyd Breeze (Lactic Acid) Pocket BR - Photo EvaluationPHASE3 COMPLETED 27 — — Oct 1, 2008 -Dec 19, 20081 Brazil
NCT00783861Dermacyd Femina (Lactic Acid) Pocket BR - CompatibilityPHASE3 COMPLETED 54 — — Oct 1, 2008 -Dec 19, 20081 Brazil
NCT00783640Dermacyd Femina (Lactic Acid) Pocket BR - Photo EvaluationPHASE3 COMPLETED 27 — — Oct 1, 2008 -Dec 19, 20081 Brazil
NCT00783939Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.PHASE3 COMPLETED 31 — — Sep 1, 2008 -Mar 6, 20091 Brazil
NCT00784056Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Photo EvaluationPHASE3 COMPLETED 26 — — Aug 1, 2008Sep 1, 2008Aug 25, 20091 Brazil
NCT00783666Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo EvaluationPHASE3 COMPLETED 26 — — Aug 1, 2008Sep 1, 2008Aug 25, 20091 Brazil
NCT00784160Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- CompatibilityPHASE3 COMPLETED 53 — — Jul 1, 2008Sep 1, 2008Aug 25, 20091 Brazil
NCT00761800Dermacyd Teen Care Tangerina Mix - CompatibilityPHASE3 COMPLETED 51 — — May 1, 2008May 1, 2008May 29, 20091 Brazil
NCT00705744Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.PHASE3 COMPLETED 26 — — Apr 1, 2008 -Apr 15, 20091 Brazil
NCT00705276Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity PotentialPHASE3 COMPLETED 26 — — Apr 1, 2008 -Apr 15, 20091 Brazil
NCT00664391Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd BreezePHASE3 COMPLETED 32 — — Jan 1, 2008 -Feb 10, 20091 Brazil
NCT00663273Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet FlowerPHASE3 COMPLETED 30 — — Dec 1, 2007 -Jan 8, 20091 Brazil
NCT00668668Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet FlowerPHASE3 COMPLETED 52 — — Dec 1, 2007 -Jan 29, 20091 Brazil
NCT00663390Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BRPHASE3 COMPLETED 30 — — Dec 1, 2007 -Jan 29, 20091 Brazil
NCT00663325Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet FlowerPHASE3 COMPLETED 30 — — Dec 1, 2007 -Jan 8, 20091 Brazil
NCT00679562Lactacyd Radiance (Lactic Acid) Prophetic Patch TestPHASE2 COMPLETED 200 — — Mar 1, 2008 -Feb 6, 20091 Thailand
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Study Endpoints
Primary Endpoints
Reduction of genital odor and increase hydration in genital mucosa
From the treatment start to the end of the study (day 67)

Patient's questionnaire will be completed at V1, V2 and V4. Reduction of vaginal odor, increase in the moisture area, and perception about some items like foam, facility of rinsing, final touch of the mucosa, final fragrance, and cleaning sensation will be rated on a 5-point scale.

Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale.
from the treatment start to the end of the study (treatment period 6 weeks)
Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.
From the treatment start to the end of the study (treatment duration 5 weeks)
Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale
from the treatment start to the end of the study (treatment period 6 weeks)
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
From the treatment start to the end of the study (treatment period 21 days)
Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.
From the treatment start to the end of the study (treatment period 21 days)
Measure of the photo irritation test and the photosensitivity byusing UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.
From the treatment start to the end of the study (treatment period 5 weeks)
Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.
From the treatment start to the end of the study (treatment period 5 weeks)
The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
Throughout the study
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze Pocket BR.
Throughout the study
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.
Throughout the study
The sensibility will be evaluated according to the skin type.
Throughout the study
The absence of primary and accumulated dermal irritability will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
Throughout the study
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale
5 weeks
The sensibility will be evaluated according the skin type.
5 weeks
Adverse events and their intensity and their association with the treatment.
21 days
The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
six weeks
Adverse events and their intensity and their association with the treatment
21 days
Reaction after patch removal.
at 15-30 minutes and day 3
Secondary Endpoints
Evaluation of the integrity of the mucosa
From the treatment start to the end of the study (day 67)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dermacyd (different fragrances)EXPERIMENTALDay 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional
Glycerine Vegetal Soap Granado TraditionalACTIVE_COMPARATORDay 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd)
Dermacyd Silver Frutal (Lactic Acid)EXPERIMENTALDermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample.
Dermacyd PH_DESILSTY_FR (Lactic Acid)EXPERIMENTALDermacyd PH\_DESILSTY\_FR (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample.
Dermacyd PH_DESILSTY_FL (Lactic Acid)EXPERIMENTALDermacyd PH\_DESILSTY\_FL (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample
Dermacyd Silver Floral (Lactic Acid)EXPERIMENTALDermacyd Silver Floral (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample.
1EXPERIMENTALLactic Acid (Dermacyd Breeze)
IEXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
LACTIC ACID (Dermacid)DRUGRoute of administration: local
Glycerine Vegetal Soap Granado TraditionalDRUGRoute of administration: local
LACTIC ACID(ND)DRUGDermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days.
Lactic AcidDRUGLactic Acid (Dermacyd Breeze)
Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)DRUGLactic Acid (Dermacyd PH\_DETINLYN Tangerine Mix)
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)DRUGLactic Acid
Lactic acid (Dermacyd Femina)DRUG -
Lactic acid (Dermacyd Femina Delicata)DRUG -
Distilled waterOTHERApplication of patches containing distilled water for 24 hours
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Perfect mucosa in the product analysis region * Volunteers with active sexual life: normal Papanicolau test performed less than one year is mandatory * Bacterioscopy describing the vaginal flora * Negative Trichomonas vaginalis test * Negative Whiff test * Willingness in using...

Countries:BrazilThailand
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