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Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility

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ClinicalTrials.gov Identifier: NCT00784160
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : August 25, 2009
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 PHDETINBACK Tangerine Mix (Lactic Acid).

Condition or disease Intervention/treatment Phase
Hygiene Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 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 Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK Tangerine Mix.
Study Start Date : July 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Lactic Acid
Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Lactic Acid



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


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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:

  • Age between 18 and 60 years old;
  • Phototype 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;
  • Personnel history of atopy;
  • History of sensitivity or irritation for topic products;
  • Active cutaneous disease;
  • Use of new drugs or cosmetics during the study;

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): NCT00784160


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00784160     History of Changes
Other Study ID Numbers: LACAC_L_04308
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009