Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation

Official Title: “Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINBACK Tangerine Mix”

The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).

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 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: Throghout 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 photoinduced 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 Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Jaderson Lima Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00783666

Study ID Number: LACAC_L_04309

ClinicalTrials.gov Identifier: NCT00783666

Health Authority: Brazil: National Health Surveillance Agency