Hygiene Clinical Trial
Official title:
Safety Dermatological Evaluation of the Acceptability With Gynecological Follow up for Dermacyd Femina Delicata
NCT number | NCT00497783 |
Other study ID # | LACTO_L_02949 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | July 6, 2007 |
Last updated | May 19, 2008 |
Start date | May 2007 |
Verified date | May 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 demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.
Status | Completed |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Integral skin in the tested region Exclusion Criteria: - Pregnancy or breastfeeding women - Use of Anti-inflammatory or immune-suppression drugs - Topical medication use at the tested region - Active cutaneous gynaecological disease which may interfere in study results - Personal history of allergic disease at the area to be treated - Allergic or atopic history The above information is not intended to contain considerations relevant to a patient's potential participation in a clinical trial. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Brazil | Sanofi-aventis | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical and local tolerability | 21 days | ||
Primary | Adverse events and their association with the treatment. | 21 days |
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