Official Title: “Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Pocket BR.”

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Femina (Lactic Acid) Pocket BR.

Study Type: Interventional

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

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: Lactic Acid
  • Drug: Lactic Acid (Dermacyd Femina)

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: 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
• Use of Antiinflammatory and/or immunosuppression drugs one month before the study;
• Personnel 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.

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/NCT00783640

Study ID Number: LACAC_L_04371

ClinicalTrials.gov Identifier: NCT00783640

Health Authority: Brazil: National Health Surveillance Agency