Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: April 18, 2008
Last updated: January 28, 2009
Last verified: January 2009

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

Condition Intervention Phase
Drug: Lactic acid (Dermacid)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR

Resource links provided by NLM:

Further study details as provided by Sanofi:

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
Experimental: I 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.


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

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 identifier: NCT00663390

São Paulo, Brazil
Sponsors and Collaborators
Study Director: Jaderson Lima Sanofi-aventis administrative office Brazil
  More Information

No publications provided

Responsible Party: GMA-CO/Medical Director, sanofi-aventis administrative office France Identifier: NCT00663390     History of Changes
Other Study ID Numbers: LACAC_L_03743
Study First Received: April 18, 2008
Last Updated: January 28, 2009
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014