Hirsutism Clinical Trial
Official title:
A 24 Week Randomised Double Blind Placebo Controlled Study to Evaluate the Atrophogenic Potential of Eflornithine in the Treatment of Women With Excessive Facial Hair
Verified date | October 2019 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate whether regular use of eflornithine 11.5% cream in treating women with facial hair will induce skin damage (atrophy) on the face and/or forearms
Status | Completed |
Enrollment | 78 |
Est. completion date | October 31, 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Female subjects with clinical diagnosis of facial hirsutism/excessive facial hair - Women of childbearing potential must agree to use an effective form of birth control for the duration of the study - Skin type I-IV - Customary frequency of removal of facial hair two or more times per week Exclusion Criteria: - Pregnant or lactating women - Severe inflammatory acne or presence of significant scarring on the face - History of skin malignancy - Connective tissue disorders |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in facial skin thickness measured by ultrasound at 24 weeks | |||
Secondary | Skin biopsies | |||
Secondary | Histology and histochemistry in the dermis | |||
Secondary | Physician Global Assessment | |||
Secondary | Subject Self-Assessment Questionnaire |
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