The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Female Androgenetic Alopecia
Intervention: 5% Minoxidil (Drug); 200mg Spironolactone (Drug); 5mg Finasteride (Drug); Placebo (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Florida Official(s) and/or principal investigator(s): Christina L. Mitchell, M.D., Principal Investigator, Affiliation: University of Florida
Overall contact: Andrea L Taylor, MD, Phone: 9417357565, Email: andrea.taylor@medicine.ufl.edu
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).
Clinical Details
Official title: The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The Savin Scale will be used to determine hair growth and/or hair loss between the groups.The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups. Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups.
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)
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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 and Contacts
Andrea L Taylor, MD, Phone: 9417357565, Email: andrea.taylor@medicine.ufl.edu
UF Health, Gainesville, Florida 32610, United States; Not yet recruiting Christina L. Mitchell, MD, Principal Investigator
Additional Information
Starting date: August 2015
Last updated: June 24, 2015
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