The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia

Conditions
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Female Androgenetic Alopecia

Intervention / Treatment
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* Drug: 5% Minoxidil
* Drug: 200mg Spironolactone
* Drug: 5mg Finasteride
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combination Group<br>This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily. | Drug: 5% Minoxidil<br>* This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.<br>* Other names: Minoxidil Topical;Drug: 200mg Spironolactone<br>* This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.<br>* Other names: Aldactone®;|
| Active Comparator: Single Group<br>This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily. | Drug: 5mg Finasteride<br>* This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.<br>* Other names: Proscar®;Other: Placebo<br>* This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.<br>* Other names: placebo topical preparation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hair loss, Post Menopausal