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

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ClinicalTrials.gov Identifier: NCT02483195
Recruitment Status : Withdrawn (PI indicating she was withdrawing her study submission due to lack of funding as of 6/20/2016)
First Posted : June 26, 2015
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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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
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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

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483195


Locations
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United States, Florida
UF Health
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Christina L. Mitchell, M.D. University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02483195    
Other Study ID Numbers: IRB201500433
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Keywords provided by University of Florida:
Hair loss
Post Menopausal
Additional relevant MeSH terms:
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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