Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)

This study has been completed.

First Received: July 6, 2007 Last Updated: May 19, 2008 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00497783

Purpose

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.

Condition	Intervention	Phase
Hygiene	Drug: Lactoserum	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Safety Dermatological Evaluation of the Acceptability With Gynecological Follow up for Dermacyd Femina Delicata

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Clinical and local tolerability [ Time Frame: 21 days ]
Adverse events and their association with the treatment. [ Time Frame: 21 days ]

Estimated Enrollment:	30
Study Start Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Integral skin in the tested region

Exclusion Criteria:

Pregnancy or breastfeeding women
Use of Anti-inflammatory or immune-suppression drugs
Topical medication use at the tested region
Active cutaneous gynaecological 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 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: NCT00497783

Locations

Brazil
Sanofi-aventis
São Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	LACTO_L_02949
Study First Received:	July 6, 2007
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00497783 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 07, 2009