Official Title: “Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Breeze Pocket BR (Lactic Acid).”

The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.

Study Type: Interventional

Study Design: Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: Dermacyd Breeze Pocket BR (Lactic Acid)
  • Dermacyd Breeze Pocket BR (Lactic Acid) during 21 consecutive days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Dermacyd Breeze Pocket BR (Lactic Acid)

Primary Measures

• Absence of irritation
  • Time Frame: Throughout the study
    Safety Issue?: No
• Good acceptability
  • Time Frame: Throughout the study
    Safety Issue?: No

Inclusion criteria:

• Integral skin test in the region;
• To use products of the same category;

Exclusion criteria:

• Lactation or gestation;
• Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;
• Cutaneous disease (local or spread) in the evaluation area;
• Pathology which may cause immunity depression, such as HIV, diabetes;
• Endocrine pathology
• Solar exposure 15 days before evaluation;
• Treatment until four months before the selection.
• Allergic or atopic history to cosmetics products
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Jaderson Lima Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00793026

Study ID Number: LACAC_L_04365

ClinicalTrials.gov Identifier: NCT00793026

Health Authority: Brazil: National Health Surveillance Agency