Dermacyd Infantile (Lactic Acid)- Compatibility.

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: NCT00881374
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 irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermic Irritability, Dermic Sensitivity) of 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)
six weeks treatment
Dermacyd Infantile (Lactic Acid)

Primary Outcome Measures :
  1. The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: During 6 weeks (i.e. treatment period) ]

Information from the National Library of Medicine

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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:

  • Photo type Skin I,II, III e 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:

  • Lactation or gestation
  • Use of Anti-inflammatory 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
  • Relevant clinical history or present evidence of alcohol abuse or others drugs
  • Non tolerance to some component of the study product.

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): NCT00881374

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

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00881374     History of Changes
Other Study ID Numbers: LACAC_L_04679
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: April 2009