Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: Dermacid Silver (Lactic acid); Drug: Glycerine Vegetal Soap Granado Traditional

Study type: Interventional

Funder types: Industry

Identifiers

NCT01126606

LACAC_L_04937

Details and patient eligibility

About

Primary Objective:

To evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception.

Secondary Objective:

To evaluate the safety in normal condition of use.

Enrollment: 70 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active sex life
• Menopause for at least 6 months
• Perfect mucosa in the evaluated area
• Use the same cosmetics category

Exclusion criteria

• Use of antiinflammatory / immunosuppression / antihistaminic drugs
• Personal history of atopy to cosmetic products
• Cutaneous active disease (local and/or general) in the evaluated area
• Disease which can cause immunosuppression, such as diabetes, HIV
• Endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland
• Intense solar exposure (to get a tan) during the 15 days before the evaluation
• Gynaecologic treatment until four weeks before the evaluation
• Whatever vaginal infection detected at time of inclusion
• Other conditions considered by the investigator as reasonable to exclude the patient from 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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70 participants in 2 patient groups

Group 1

Experimental group

Description:

Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH_DESYLSTY_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional

Treatment:

Drug: Glycerine Vegetal Soap Granado Traditional

Drug: Dermacid Silver (Lactic acid)

Group 2

Experimental group

Description:

Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH_DESYLSTY_FR

Treatment:

Drug: Glycerine Vegetal Soap Granado Traditional

Drug: Dermacid Silver (Lactic acid)