Dermacyd in Odor Reducing.

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.

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.

Study Overview

• Status: Completed
• Conditions: Hygiene
• Intervention / Treatment: Drug: LACTIC ACID (Dermacid); Drug: Glycerine Vegetal Soap Granado Traditional

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Osasco, Brazil, 06023-000
    • Sanofi-Aventis Investigational Site Number 076-001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dermacyd (different fragrances); Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional	Drug: LACTIC ACID (Dermacid); Route of administration: local; Drug: Glycerine Vegetal Soap Granado Traditional; Route of administration: local
ACTIVE_COMPARATOR: Glycerine Vegetal Soap Granado Traditional; Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd)	Drug: LACTIC ACID (Dermacid); Route of administration: local; Drug: Glycerine Vegetal Soap Granado Traditional; Route of administration: local

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: July 7, 2010
• First Submitted That Met QC Criteria: July 7, 2010
• First Posted (ESTIMATE): July 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 4, 2011
• Last Update Submitted That Met QC Criteria: January 3, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: LACAC_L_05401; U1111-1115-3484 (OTHER: UTN)