Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability.

Verified by: Sanofi-Aventis, December 2008
First Received: November 17, 2008 | Last Updated: December 18, 2008 | Phase: Phase 3 | Start Date: November 2008
Overall Status: Completed | Estimated Enrollment: 30
  • …
  • Tell a FriendPrint

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

Brief Summary

Official Title: “Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Femina 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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
  • Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Absence of irritation
    • Time Frame: From the start to the end of the study
      Safety Issue?: No
  • Good acceptability
    • Time Frame: From the start to the end of the study
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Jaderson Lima Study Director Sanofi-Aventis  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00794612

Study ID Number: LACAC_L_04369

ClinicalTrials.gov Identifier: NCT00794612

Health Authority: Brazil: National Health Surveillance Agency

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00794612