Recent Updates
Recently added Catalysts

Lactic Acid

Phase 4

Undisclosed | Small molecule | Other |Sanofi|Trials Updated: Jan 4, 2011

Lactic Acid development status

Highest phase Phase 4 (NCT00712868)
Phase scored for SNYPhase 3
Registered trials 8 across 1 sponsor since May 2008

Lactic Acid target and mechanism

ModalitySmall molecule

Also known as Lactic acid (Dermacid), LACTIC ACID(ND), Lactic acid (Dermacyd Femina), Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix), Lactic acid (Dermacyd Femina Delicata), Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix), Lactacyd Radiance

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials37
Total Enrollment1,717

FDA Designations

No designations recorded

Lactic Acid clinical trials

Lactic Acid · 37 trials · 2 indications

Phase 3 36Phase 2 1
NCT01158365Dermacyd in Odor Reducing.Hygiene
COMPLETED230 Analytics
NCT00933946Dermacyd Silver Frutal (Lactic Acid) - Compatibility.Hygiene
COMPLETED55 Analytics
NCT00933907Dermacyd PH_DESILSTY_FR (Lactic Acid) - Compatibility - Stay on FrutalHygiene
COMPLETED55 Analytics
NCT00933842Dermacyd PH_DESILSTY_FL (Lactic Acid) - Photo Evaluation - Stay on FloralHygiene
COMPLETED27 Analytics
NCT00933712Dermacyd Silver Floral (Lactic Acid) - Compatibility.Hygiene
COMPLETED55 Analytics
NCT00933699Dermacyd PH_DESILSTY_FL (Lactic Acid) - Acceptability - Stay on Floral.Hygiene
COMPLETED32 Analytics
NCT00933569Dermacyd Silver Floral (Lactic Acid) - Acceptability.Hygiene
COMPLETED31 Analytics
NCT00933504Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on FloralHygiene
COMPLETED55 Analytics
NCT00933413Dermacyd Silver Frutal (Lactic Acid) - Acceptability.Hygiene
COMPLETED30 Analytics
NCT00933257Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on FrutalHygiene
COMPLETED27 Analytics
PHASE3COMPLETED
Dermacyd in Odor Reducing.
HygieneUnlock trial analytics
PHASE3COMPLETED
Dermacyd Silver Frutal (Lactic Acid) - Compatibility.
HygieneUnlock trial analytics
PHASE3COMPLETED
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Compatibility - Stay on Frutal
HygieneUnlock trial analytics
PHASE3COMPLETED
Dermacyd PH_DESILSTY_FL (Lactic Acid) - Photo Evaluation - Stay on Floral
HygieneUnlock trial analytics
PHASE3COMPLETED
Dermacyd Silver Floral (Lactic Acid) - Compatibility.
HygieneUnlock trial analytics
PHASE3COMPLETED
Dermacyd PH_DESILSTY_FL (Lactic Acid) - Acceptability - Stay on Floral.
HygieneUnlock trial analytics
PHASE3COMPLETED
Dermacyd Silver Floral (Lactic Acid) - Acceptability.
HygieneUnlock trial analytics
PHASE3COMPLETED
Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on Floral
HygieneUnlock trial analytics
PHASE3COMPLETED
Dermacyd Silver Frutal (Lactic Acid) - Acceptability.
HygieneUnlock trial analytics
PHASE3COMPLETED
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal
HygieneUnlock trial analytics

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 photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to 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
The absence of primary and accumulated dermal irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
six weeks
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)
Unlock Study Endpoints

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 Femina)
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 Femina)
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)DRUGLactic Acid
Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)DRUGLactic Acid (Dermacyd PH\_DETINLYN Tangerine Mix)
Lactic acid (Dermacyd Femina)DRUG -
Lactic acid (Dermacyd Femina Delicata)DRUG -
Distilled waterOTHERApplication of patches containing distilled water for 24 hours
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about Lactic Acid

What is Lactic Acid?

Lactic Acid is a small molecule developed by Sanofi under the Dermacyd line of hygiene products. It has been studied in Phase 3 trials focused on hygiene and odor reduction, including a completed study of 230 women in Brazil. It is not described as a treatment for a specific disease indication.

What is Lactic Acid used for?

Lactic Acid has been evaluated for hygiene and odor reduction in Phase 3 clinical trials. The completed studies enrolled healthy volunteers, primarily women aged 18 and older, in Brazil. The specific medical indication is not publicly disclosed, and the trials centered on hygiene-related endpoints.

Who makes Lactic Acid?

Sanofi, which trades under the ticker SNY, is the developer of Lactic Acid. The drug is studied under the Dermacyd brand family, and Sanofi has sponsored the completed Phase 3 trials registered for this asset.

What phase is Lactic Acid in?

Lactic Acid has completed Phase 3 clinical development. All 37 registered trials are completed, with no active trials currently listed. The Phase 3 studies were placebo-controlled and randomized, and enrolled a total of 1,717 participants across the program.

What clinical trials is Lactic Acid in?

Lactic Acid has 37 completed clinical trials, including NCT01158365, a Phase 3 odor-reducing study of 230 women in Brazil, and NCT00933946, NCT00933907, and NCT00933842, which were Phase 3 compatibility and photo-evaluation studies of 55, 55, and 27 participants respectively.

Is Lactic Acid the same as Dermacid or Dermacyd Femina?

Yes, Lactic Acid is also known as Dermacid and Dermacyd Femina, along with related names such as Dermacyd Femina Delicata and Dermacyd PH_DETINBACK Tangerine Mix. These are alternative names for the same Sanofi asset studied in the Dermacyd hygiene trials.