Dermacyd in Odor Reducing.

Hygiene Clinical Trial

Official title:

Single Center, Open, Cross-over, Phase III Study for Comparative Evaluation of Safety Use and Efficacy in the Odor Reduce and Vaginal Moisturize Increase for Intimates Use Products Dermacyd Femina Delicata, Dermacyd Femina Breeze, Dermacyd Teen Sweet Flower, Dermacyd Teen Fresh Mix and Dermacyd Femina Comparing to the Control Product Glycerine Vegetal Soap Granado Traditional.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158365
• Other study ID #: LACAC_L_05401
• Secondary ID: U1111-1115-3484
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2010
• Last updated: January 3, 2011
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional

Secondary Objective:

• To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 preservative in the sexual intercourse during the study period

• Use the same category cosmetics products

• Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

• Use of antiinflammatory / immunosuppression / antihistaminic drugs

• Atopic or allergy history to cosmetic products

• Active cutaneous disease (local and/or disseminated) in the evaluated area

• Disease which can cause immunosuppression, such as diabetes, HIV, etc.

• Endocrine pathology such as thyroid disease, ovarian or adrenal gland disturbs

• Intense solar exposure (to get a tan) during the 15 days before the evaluation

• Gynecologic treatment until four weeks before the evaluation

• Any vaginal infection detected during the inclusion

• Other conditions considered by the investigator as reasonable for exclude the patient in the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• LACTIC ACID (Dermacid)
Route of administration: local
• Glycerine Vegetal Soap Granado Traditional
Route of administration: local

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Investigational Site Number 076-001	Osasco

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of genital odor and increase hydration in genital mucosa	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.	From the treatment start to the end of the study (day 67)	No
Secondary	Evaluation of the integrity of the mucosa	Onset of erythema, edema, scaling, blisters or other clinical sign will be evaluated.	From the treatment start to the end of the study (day 67)	Yes