Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: November 17, 2008
Last updated: December 18, 2008
Last verified: December 2008

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

Condition Intervention Phase
Drug: Dermacyd Breeze Pocket BR (Lactic Acid)
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absence of irritation [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Good acceptability [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dermacyd Breeze Pocket BR (Lactic Acid)
Drug: Dermacyd Breeze Pocket BR (Lactic Acid)
Dermacyd Breeze Pocket BR (Lactic Acid) during 21 consecutive 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;
  • 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.

  Contacts and Locations
Please refer to this study by its identifier: NCT00793026

Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Study Director: Jaderson Lima Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00793026     History of Changes
Other Study ID Numbers: LACAC_L_04365
Study First Received: November 17, 2008
Last Updated: December 18, 2008
Health Authority: Brazil: National Health Surveillance Agency processed this record on April 16, 2014