Official Title: “Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)”

The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINLYN 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_DETINLYN Tangerine Mix)
  • Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)

Primary Measures

• The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.
  • Time Frame: Throughout the study
    Safety Issue?: No
• The sensibility will be evaluated according to the skin type.
  • Time Frame: Throughout the study
    Safety Issue?: No

Inclusion criteria:

• Age between 18 and 60 years old;
• Phototype Skin II and III;
• 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 Antiinflammatory and/or immunossupression drugs 15 days before the selection;
• Diseases which can cause immunity decrease, such as HIV, diabetes;
• Use of drug photosensitizer;
• History of sensitivity or irritation for topic products;
• Active cutaneous disease which can change the study results;
• History of photodermatosis active;
• Family or personal antecedent of cutaneous photo induced neoplasias;
• Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
• Intense solar exposure in the study area;
• 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/NCT00784056

Study ID Number: LACAC_L_04306

ClinicalTrials.gov Identifier: NCT00784056

Health Authority: Brazil: National Health Surveillance Agency