Hygiene Clinical Trial
Official title:
Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Breeze Pocket BR (Lactic Acid).
Verified date | December 2008 |
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 of the gynaecological formulation in normal conditions of use.
Status | Completed |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion criteria: - Integral skin test in the region; - To use products of the same category; Exclusion criteria: - Lactation or gestation; - Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs; - Cutaneous disease (local or spread) in the evaluation area; - Pathology which may cause immunity depression, such as HIV, diabetes; - Endocrine pathology - Solar exposure 15 days before evaluation; - Treatment until four months before the selection. - Allergic or atopic history to cosmetics products 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 | Absence of irritation | Throughout the study | No | |
Primary | Good acceptability | Throughout the study | No |
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