Dermacyd in Odor Reducing.

NCT ID: NCT01158365

Last Updated: 2011-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2010-12-31

Brief 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.

Conditions

Hygiene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

LACTIC ACID (Dermacid)

Intervention Type: DRUG

Route of administration: local

Glycerine Vegetal Soap Granado Traditional

Intervention Type: DRUG

Route of administration: local

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)

Group Type: ACTIVE_COMPARATOR

LACTIC ACID (Dermacid)

Intervention Type: DRUG

Route of administration: local

Glycerine Vegetal Soap Granado Traditional

Intervention Type: DRUG

Route of administration: local

Interventions

LACTIC ACID (Dermacid)

Route of administration: local

Intervention Type: DRUG

Glycerine Vegetal Soap Granado Traditional

Route of administration: local

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Investigational Site Number 076-001

Osasco, , Brazil

Countries

Brazil

Other Identifiers

U1111-1115-3484

Identifier Type: OTHER

Identifier Source: secondary_id

LACAC_L_05401

Identifier Type: -

Identifier Source: org_study_id