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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 March 26, 2015