Official Title: “Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK Tangerine Mix.”

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).

Study Type: Interventional

Study Design: Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
  • Lactic Acid

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Lactic Acid

Primary Measures

• 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
    Safety Issue?: No

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;

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Jaderson Lima Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00784160

Study ID Number: LACAC_L_04308

ClinicalTrials.gov Identifier: NCT00784160

Health Authority: Brazil: National Health Surveillance Agency