Dermacyd Infantile (Lactic Acid) - Photo Evaluation.

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. Identifier: NCT00881348
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : April 15, 2009
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Brief Summary:

Primary Objective:

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

Condition or disease Intervention/treatment Phase
Hygiene Drug: LACTIC ACID(ND) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Infantile (Lactic Acid).
Study Start Date : February 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Arm Intervention/treatment
Experimental: Dermacyd infantile (Lactic Acid)
5 weeks treatment
Dermacyd infantile (Lactic Acid)

Primary Outcome Measures :
  1. The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type. [ Time Frame: During 5 weeks (i.e. treatment period) ]

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

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.

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 identifier (NCT number): NCT00881348

Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Study Director: Jaderson Lima Sanofi

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00881348     History of Changes
Other Study ID Numbers: LACAC_L_04680
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: April 2009