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

University of Florida

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Female Androgenetic Alopecia

Interventions

5% MinoxidilDRUG

This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.

200mg SpironolactoneDRUG

This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.

5mg FinasterideDRUG

This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.

Eligibility

Sex: FEMALEMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UF Health

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: Change at 0, 4, 8, and 12 months

Data from ClinicalTrials.gov

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