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

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2018

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

  • Drug: 5% Minoxidil
    • This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
  • Drug: 200mg Spironolactone
    • This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
  • Drug: 5mg Finasteride
    • This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
  • Other: Placebo
    • This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.

Arms, Groups and Cohorts

  • Active Comparator: Combination Group
    • This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.
  • Active Comparator: Single Group
    • This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily.

Clinical Trial Outcome Measures

Primary Measures

  • The Savin Scale will be used to determine hair growth and/or hair loss between the groups.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christina L. Mitchell, M.D., Principal Investigator, University of Florida

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