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

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Brief Title

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

Official Title

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

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).
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

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


Condition

Female Androgenetic Alopecia

Intervention

5% Minoxidil

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

August 2016

Completion Date

August 2018

Primary Completion Date

August 2018

Eligibility 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.
      

Gender

Female

Ages

60 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Christina L. Mitchell, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02483195

Organization ID

IRB201500433


Responsible Party

Sponsor

Study Sponsor

University of Florida


Study Sponsor

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


Verification Date

August 2016