Female Androgenetic Alopecia
Conditions
Keywords
Hair loss, Post Menopausal
Brief summary
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
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)
Interventions
DRUG5% Minoxidil
This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
DRUG200mg Spironolactone
This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
DRUG5mg Finasteride
This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
OTHERPlacebo
This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Savin Scale will be used to determine hair growth and/or hair loss between the groups. | Change at 0, 4, 8, and 12 months | This will be based on a photographic scale from D1 to D8. With D1 being minimal disease and D8 being severe alopecia. |
| The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups. | Change at 0, 4, 8, and 12 months | This scale is based on the hair loss pattern. Ludwig Scale: Left = pattern 1, middle = pattern 2, right = pattern 3 |
| Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups. | Change at 0, 4, 8, and 12 months | 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 |
Countries
United States
Outcome results
None listed