Dermacyd in Odor Reducing.

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: LACTIC ACID (Dermacid); Drug: Glycerine Vegetal Soap Granado Traditional

Study type: Interventional

Funder types: Industry

Identifiers

NCT01158365

U1111-1115-3484 (Other Identifier)

LACAC_L_05401

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Dermacyd (different fragrances)

Experimental group

Description:

Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional

Treatment:

Drug: Glycerine Vegetal Soap Granado Traditional

Drug: LACTIC ACID (Dermacid)

Glycerine Vegetal Soap Granado Traditional

Active Comparator group

Description:

Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd)

Treatment:

Drug: Glycerine Vegetal Soap Granado Traditional

Drug: LACTIC ACID (Dermacid)