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

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 Overview

• Status: Withdrawn
• Conditions: Female Androgenetic Alopecia
• Intervention / Treatment: Drug: 5% Minoxidil; Drug: 200mg Spironolactone; Drug: 5mg Finasteride; Other: Placebo

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)

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 5% Minoxidil; This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.; Other Names: Rogaine®; Theroxidil®; Minoxidil Topical; Drug: 200mg Spironolactone; This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.; Other Names: Aldactone®
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.	Drug: 5mg Finasteride; This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.; Other Names: Proscar®; Propecia®; Other: Placebo; This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.; Other Names: placebo topical preparation

What is the study measuring?

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 alopecia1: slightly improved alopecia2: moderately improved alopecia3: markedly improved alopecia	Change at 0, 4, 8, and 12 months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Christina L. Mitchell, M.D., University of Florida

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 26, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Hair loss; Post Menopausal
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Steroid Synthesis Inhibitors; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; 5-alpha Reductase Inhibitors; Spironolactone; Finasteride; Minoxidil
• Other Study ID Numbers: IRB201500433