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Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370162
First Posted: August 30, 2006
Last Update Posted: May 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370162


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

ClinicalTrials.gov Identifier: NCT00370162     History of Changes
Other Study ID Numbers: LACTO_L_01839
First Submitted: August 29, 2006
First Posted: August 30, 2006
Last Update Posted: May 16, 2008
Last Verified: May 2008