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

NCT02483195 | Withdrawn Phase 4

• 1 other identifier: IRB201500433
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Female Androgenetic Alopecia

Keywords

Hair loss; Post Menopausal

Outcome Measures

Primary Outcomes (3)

• 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 alopecia * 1: slightly improved alopecia * 2: moderately improved alopecia * 3: markedly improved alopecia

  Change at 0, 4, 8, and 12 months

Study Arms (2)

Combination Group

ACTIVE COMPARATOR

This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.

Drug: 5% Minoxidil; Drug: 200mg Spironolactone

Single Group

ACTIVE COMPARATOR

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; Other: Placebo

Interventions

5% Minoxidil DRUG

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

Also known as: Rogaine®, Theroxidil®, Minoxidil Topical

Combination Group

200mg Spironolactone DRUG

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

Also known as: Aldactone®

Combination Group

5mg Finasteride DRUG

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

Also known as: Propecia®, Proscar®

Single Group

Placebo OTHER

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

Also known as: placebo topical preparation

Single Group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• postmenopausal (\>60 years old or with total hysterectomy)
• diagnosed with androgenetic alopecia
• no chemical processing or changes in hair products throughout the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Spironolactone; Finasteride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstenes; Androstanes; Azasteroids; Steroids, Heterocyclic

Study Officials

• Christina L. Mitchell, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 2, 2016

Record last verified: 2016-08

Locations

US (1)