Female Androgenetic Alopecia Clinical Trial
Official title:
The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
| Verified date | August 2016 |
| Source | University of Florida |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The investigators propose to conduct a head-to-head, randomized clinical trial to compare the effectiveness of Minoxidil with Spironolactone and Finasteride in treating postmenopausal females with Androgenetic Alopecia (AGA).
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 2018 |
| Est. primary completion date | August 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - female - postmenopausal (>60 years old or with total hysterectomy) - diagnosed with androgenetic alopecia - no chemical processing or changes in hair products throughout the study Exclusion Criteria: - men - premenopausal women (<60 or without hysterectomy) - participants allergic to any of the study medications (minoxidil, finasteride, spironolactone) - participants with other co-existing forms of alopecia (traction, alopecia areata, or scarring alopecias) - participants with obstructive uropathy or advanced liver disease - prior hair loss treatment within the last 6 months - hair loss from the chemotherapy or other medication-induced alopecia - Hair loss for greater than 5 years, as medical therapy is unlikely to have much effect at restoring hair follicles inactive for that long of a period. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | UF Health | Gainesville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florida |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Savin Scale will be used to determine hair growth and/or hair loss between the groups. | This will be based on a photographic scale from D1 to D8. With D1 being minimal disease and D8 being severe alopecia. | Change at 0, 4, 8, and 12 months | No |
| Primary | The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups. | This scale is based on the hair loss pattern. Ludwig Scale: Left = pattern 1, middle = pattern 2, right = pattern 3 | Change at 0, 4, 8, and 12 months | No |
| Primary | Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups. | The value will be one of 7 numbers, ranging from -3 to +3. The values will stand for the following: 3: markedly worsened alopecia 2: moderately worsened alopecia 1: slightly worsened alopecia 0: no change in alopecia 1: slightly improved alopecia 2: moderately improved alopecia 3: markedly improved alopecia |
Change at 0, 4, 8, and 12 months | No |