Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

Phase 3

Completed

• Conditions: Hygiene
• Interventions: Drug: Lactic acid (Dermacid)

• Registration Number: NCT00663325
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-01
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-07
• Last Update Posted: 2009-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Integral skin test in the region;

Exclusion Criteria

• Lactation or gestational risk or gestation;
• Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
• Topical medication use at the region to be treated;
• Cutaneous disease or active gynecological disease which may interfere in study results;
• Personal history of allergic disease at the area to be treated;
• Allergic or atopic history;

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Lactic acid (Dermacid)	Lactic acid in small quantity during 21 days

Primary Outcome Measures

Name	Time	Method
Adverse events and their intensity and their association with the treatment	21 days

Trial Locations

Locations (1)

Sanofi-aventis; 🇧🇷 São Paulo, Brazil