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
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 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 August 01, 2014