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

This study has been completed.

First Received: April 18, 2008 Last Updated: January 7, 2009 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00663325

Purpose

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.

Condition	Intervention	Phase
Hygiene	Drug: Lactic acid (Dermacid)	Phase III

MedlinePlus related topics: Methamphetamine

Drug Information available for: Lactic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Tangerina Mix

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Adverse events and their intensity and their association with the treatment [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	December 2007
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Eligibility

Ages Eligible for Study:	10 Years to 20 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663325

Locations

Brazil
Sanofi-aventis
São Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima

Sanofi-aventis administrative office Brazil

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis administrative office France ( GMA-CO/Medical Director )
Study ID Numbers:	LACAC_L_03735
Study First Received:	April 18, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00663325 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Study placed in the following topic categories:

Methamphetamine
Amphetamine

ClinicalTrials.gov processed this record on May 07, 2009