Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: July 6, 2007
Last updated: May 19, 2008
Last verified: May 2008

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.

Condition Intervention Phase
Drug: Lactoserum
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety Dermatological Evaluation of the Acceptability With Gynecological Follow up for Dermacyd Femina Delicata

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Clinical and local tolerability [ Time Frame: 21 days ]
  • Adverse events and their association with the treatment. [ Time Frame: 21 days ]

Estimated Enrollment: 30
Study Start Date: May 2007

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 Anti-inflammatory or immune-suppression drugs
  • Topical medication use at the tested region
  • Active cutaneous gynaecological disease which may interfere in study results
  • Personal history of allergic disease at the area to be treated
  • Allergic or atopic history

The above information is not intended to contain considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its identifier: NCT00497783

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

No publications provided Identifier: NCT00497783     History of Changes
Other Study ID Numbers: LACTO_L_02949
Study First Received: July 6, 2007
Last Updated: May 19, 2008
Health Authority: Brazil: National Health Surveillance Agency processed this record on April 17, 2014