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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

Page last updated: August 23, 2015

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