Official Title: “Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid).”

To prove the safety of the gynaecological formulation in normal conditions of use.

Study Type: Interventional

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

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)

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 treatment start to the end of study
    Safety Issue?: No

Inclusion Criteria:

• Integral skin test in the region,
• Use of cosmetic product of the same category

Exclusion Criteria:

• Lactation or gestational risk or gestation
• Use of Anti-inflammatory, immunosuppression or anti-histaminic 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 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/NCT00785148

Study ID Number: LACAC_L_04298

ClinicalTrials.gov Identifier: NCT00785148

Health Authority: Brazil: National Health Surveillance Agency

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