Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: August 29, 2006
Last updated: May 15, 2008
Last verified: May 2008

The purpose of this study is to demonstrate the safety of the gynaecological formulation in normal and usual usage condition.

Condition Intervention Phase
Drug: lactoserum
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata New Fragrance

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Adverse Events and its association with the drug in study

Estimated Enrollment: 30
Study Start Date: June 2006

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

Inclusion Criteria:

  • Integral skin in the tested region

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Use of antiinflammatory or immunosuppression drugs
  • Topical medication use at the tested region
  • Active cutaneous gynaecological disease
  • Personal history of allergic disease at the area to be treated
  • Allergic or atopic history
  Contacts and Locations
Please refer to this study by its identifier: NCT00370162

São Paulo, Brazil
Sponsors and Collaborators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided Identifier: NCT00370162     History of Changes
Other Study ID Numbers: LACTO_L_01839
Study First Received: August 29, 2006
Last Updated: May 15, 2008
Health Authority: Brazil: National Health Surveillance Agency processed this record on April 17, 2014