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Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00497783
First received: July 6, 2007
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  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: 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
  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 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 ClinicalTrials.gov identifier: NCT00497783

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: 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

ClinicalTrials.gov processed this record on May 21, 2013