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Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: July 6, 2007
Last updated: May 19, 2008
Last verified: May 2008

July 6, 2007
May 19, 2008
May 2007
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  • Clinical and local tolerability [ Time Frame: 21 days ]
  • Adverse events and their association with the treatment. [ Time Frame: 21 days ]
Same as current
Complete list of historical versions of study NCT00497783 on Archive Site
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Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)
Safety Dermatological Evaluation of the Acceptability With Gynecological Follow up for Dermacyd Femina Delicata
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.
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Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Drug: Lactoserum
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.

18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Jaderson Lima Sanofi
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP