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Dermacyd Teen Care Tangerina Mix - 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: NCT00761800
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : May 29, 2009
Information provided by:

Brief Summary:
The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Teen Care Tangerina Mix.

Condition or disease Intervention/treatment Phase
Hygiene Drug: Lactic acid Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 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 Dermal Irritability, Dermal Sensitivity) of Dermacyd Teen Care Tangerina Mix .
Study Start Date : May 2008
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The absence of primary and accumulated dermal irritability will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: Throughout the study ]

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:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Phototype Skin I,II, III e IV
  • Integral skin test in the region

Exclusion Criteria:

  • Lactation or gestation
  • Use of Anti-inflammatory and/or immuno-Supression drugs 1 month before the study
  • Personal history of atopy
  • History of sensitivity or irritation for topic products
  • Active cutaneous disease
  • Use of new drugs 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 identifier (NCT number): NCT00761800

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

Responsible Party: Medical Affairs Study director, Sanofi-aventis Identifier: NCT00761800     History of Changes
Other Study ID Numbers: LACAC_L_04087
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: May 29, 2009
Last Verified: May 2009