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

Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Tangerina Mix

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.

Study Overview

• Status: Completed
• Conditions: Hygiene
• Intervention / Treatment: Drug: Lactic acid (Dermacid)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Lactic acid in small quantity during 21 days	Drug: Lactic acid (Dermacid); Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events and their intensity and their association with the treatment	21 days

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Jaderson Lima, Sanofi-aventis administrative office Brazil

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Estimate): January 8, 2009
• Last Update Submitted That Met QC Criteria: January 7, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: LACAC_L_03735