Hygiene Clinical Trial
Official title:
Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
Verified date | March 2009 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Interventional |
The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
Status | Completed |
Enrollment | 31 |
Est. completion date | |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 10 Years to 20 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Brazil | Sanofi-Aventis Administrative Office | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. | From the treatment start to the end of the study | No |
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