Dermacyd Breeze (Lactic Acid) Pocket BR - Compatibility

Official Title: “Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Breeze Pocket BR.”

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Breeze (Lactic Acid) Pocket BR.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Lactic Acid (Dermacyd Breeze)

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
• Use of Antiinflammatory and/or immunosuppression drugs one month before the study;
• Personal 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 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/NCT00784121

Study ID Number: LACAC_L_04366

ClinicalTrials.gov Identifier: NCT00784121

Health Authority: Brazil: National Health Surveillance Agency