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

• ClinicalTrials.gov Identifier: NCT02483195
• Recruitment Status: Withdrawn
• First Posted: June 26, 2015
• Last Update Posted: September 2, 2016
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Female Androgenetic Alopecia	Drug: 5% Minoxidil; Drug: 200mg Spironolactone; Drug: 5mg Finasteride; Other: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
• Study Start Date: August 2016
• Estimated Primary Completion Date: August 2018
• Estimated Study Completion Date: August 2018

Arms and Interventions

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 Name: 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: Propecia®; Proscar®; Other: Placebo; This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.; Other Name: placebo topical preparation

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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
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

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

UF Health

Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Investigators

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

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02483195 History of Changes
• Other Study ID Numbers: IRB201500433
• First Posted: June 26, 2015
• Last Update Posted: September 2, 2016
• Last Verified: August 2016

Keywords provided by University of Florida:

Hair loss; Post Menopausal

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Minoxidil; Spironolactone; Finasteride; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents; 5-alpha Reductase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Urological Agents; Antihypertensive Agents; Vasodilator Agents