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Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497783
First Posted: July 9, 2007
Last Update Posted: May 20, 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 gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.

Condition Intervention Phase
Hygiene Drug: Lactoserum Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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
  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 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
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): NCT00497783


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

ClinicalTrials.gov Identifier: NCT00497783     History of Changes
Other Study ID Numbers: LACTO_L_02949
First Submitted: July 6, 2007
First Posted: July 9, 2007
Last Update Posted: May 20, 2008
Last Verified: May 2008