Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00370162
First received: August 29, 2006
Last updated: May 15, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention Phase
Hygiene
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
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00370162

Locations
Brazil
Sanofi-Aventis
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided

ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on April 17, 2014