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Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)

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ClinicalTrials.gov Identifier: NCT00497692
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : May 20, 2008
Sponsor:
Information provided by:
Sanofi

Brief Summary:
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina Delicata.

Condition or disease Intervention/treatment Phase
Hygiene Drug: Lactoserum Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) for Dermacyd Femina Delicata
Study Start Date : May 2007



Primary Outcome Measures :
  1. Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG) [ Time Frame: six weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Phototypes: I, II, III and IV
  • Integral skin test in the region

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Use of antinflammatory or immune-suppression drugs
  • Personal history of atopy
  • History of sensibilization or irritation for topic products
  • Active cutaneous disease
  • Use of new drugs and/or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT00497692


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

ClinicalTrials.gov Identifier: NCT00497692     History of Changes
Other Study ID Numbers: LACTO_L_02948
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008