Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.

Official Title: “Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).”

The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
  • Time Frame: From the treatment start to the end of the study
    Safety Issue?: No

Inclusion criteria:

• Age between 10 and 20 years old;
• Integral skin test in the region;
• Use of cosmetic product of the same category;
• Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

• Lactation or gestational risk or gestation;
• Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;
• Atopic antecedent or allergic to cosmetic product;
• Active cutaneous disease in the evaluation area;
• Diseases which cause immunology decrease, such as diabetes and HIV;
• Endocrinal pathologies;
• Intense solar exposure 15 days before the evaluation;
• Treatment until four months before the selection;
• 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: 10 Years

Maximum Age for this Clinical Trial: 20 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/NCT00783939

Study ID Number: LACAC_L_04307

ClinicalTrials.gov Identifier: NCT00783939

Health Authority: Brazil: National Health Surveillance Agency