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PI indicating she was withdrawing her study submission due to lack of funding as of 6/20/2016
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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).
Participants diagnosed with AGA will be randomized into one of the two treatment arms outlined below, and will take the assigned treatment for a total duration of 12 months. Medications will be dispensed by a nurse who is blinded to the participants within each treatment group. Global photograph assessment and participant questionnaires at 0, 4, 8 and 12 months will be the primary means to determine improvement in hair loss.
Compare the following interventions in treating postmenopausal female AGA:
A) Combination 5% Minoxidil and 200mg Spironolactone (Combination Group) B) 5mg Finasteride with placebo topical preparation (Single Group)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Group | Active Comparator | This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily. |
|
| Single Group | Active Comparator | This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% Minoxidil | Drug | This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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:
| Change at 0, 4, 8, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina L. Mitchell, M.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health | Gainesville | Florida | 32610 | United States |
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| 200mg Spironolactone | Drug | This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily. |
|
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| 5mg Finasteride | Drug | This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily. |
|
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| Placebo | Other | This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily. |
|
|
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D013148 | Spironolactone |
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
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