Hygiene Clinical Trial
Official title:
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up - Dermacyd PH_DESILSTY_FL (Lactic Acid).
Verified date | September 2010 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Interventional |
Primary Objective:
To prove the safety of the gynaecological formulation in normal conditions of use.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion criteria: - Integral vaginal mucosa in the product analysis region - Use the same category cosmetics products - Willingness in following the study procedures and to be present in the clinic at the days and scheduled time; Exclusion criteria: - Use of Anti-inflammatory, immunossupression or antihistaminics drugs - Allergic or atopic history to cosmetics products - Cutaneous active disease (local and/or general) in the evaluated area - Disease which can cause immunosuppresion, such as diabetes, HIV - Endocrinology pathology such as thyroid gland, ovary and adrenal gland - Intensive solar exposure until 15 days before evaluation - Gynecological treatment until four weeks before the study - Other reason considered by the investigator as a reason for not being included. 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 Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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 (treatment period 21 days) | No |
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