Status:

COMPLETED

Dermacyd Infantile (Lactic Acid) - Photo Evaluation.

Lead Sponsor:

Sanofi

Conditions:

Hygiene

Eligibility:

All Genders

18-60 years

Phase:

PHASE4

Brief Summary

Primary Objective: To demonstrate the absence of photo irritation and photosensitization potential of the product Dermacyd Infantile (Lactic Acid).

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Phototype Skin I, II, III and IV
  • Integral skin test in the region
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.
  • Exclusion criteria:
  • Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs
  • Lactation or gestation
  • Use of Anti-inflammatory drugs 30 days and/or immunosuppressant drugs during 3 months before the selection
  • Diseases which can cause immunity decrease, such as HIV, diabetes
  • Previous atopy
  • History of sensitivity or irritation for topic products
  • Active cutaneous diseases which can interfere in the study results
  • Use of new drugs and/ or cosmetics during the study
  • Cutaneous reactivity
  • Previous participation in studies, which had used the product
  • Volunteers who have immunodeficiency congenital or acquired.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    February 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2009

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT00881348

    Start Date

    February 1 2009

    End Date

    March 1 2009

    Last Update

    April 15 2009

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Sanofi-Aventis Administrative Office

    São Paulo, Brazil