Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
NCT ID: NCT04582383
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
350 participants
INTERVENTIONAL
2022-03-30
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Spironolactone
In this arm, participants will receive spironolactone 100mg/day for the entirety of the study. To maximize the generalizability of the study, participants will be allowed to continue their current topical regimen as long as no changes were made in the 4 weeks prior to randomization. No additions to their topical regimen may be made during the study period.
Spironolactone
Dispensation of spironolactone according to the arm description.
Doxycycline hyclate
This arm is an active-comparator arm in which participants will receive doxycycline hyclate 100mg/day for the entirety of the study. To maximize the generalizability of the study, participants will be allowed to continue their current topical regimen as long as no changes were made in the 4 weeks prior to randomization. No additions to their topical regimen may be made during the study period.
Doxycycline Hyclate
Dispensation of doxycycline hyclate according to the arm description.
Interventions
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Spironolactone
Dispensation of spironolactone according to the arm description.
Doxycycline Hyclate
Dispensation of doxycycline hyclate according to the arm description.
Eligibility Criteria
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Inclusion Criteria
* Age 16-40 years old
* Acne defined as at least 10 inflammatory papules or pustules and an Investigator's Global Assessment (IGA) score of at least 2 as measured by the Comprehensive Acne Severity Scale
* Not currently pregnant or planning to become pregnant
Exclusion Criteria
* Heart disease
* Renal disease
* Liver disease
* Orthostatic hypotension
* Addison's disease
* History of hyperkalemia
* Allergy to tetracycline-class antibiotic
* Allergy to spironolactone
* Concomitant use of medications known to interact with spironolactone or doxycycline or that may increase the risk for hyperkalemia, including angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, eplerenone, nonsteroidal anti-inflammatory drugs, and digoxin.
* Treatment with spironolactone, an oral antibiotic, laser, photodynamic therapy, or chemical peel within the past 4 weeks
* Treatment with isotretinoin within the past 3 months
* Sebacia laser treatment within the past 12 months
16 Years
40 Years
FEMALE
Yes
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Locations
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Johnson Dermatology
Fort Smith, Arkansas, United States
University of California San Francisco
San Francisco, California, United States
Cura Clinical Research
Sherman Oaks, California, United States
University of Miami
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
New York University
New York, New York, United States
Northwell Health
North New Hyde Park, New York, United States
Dermatologists of Central States
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Arlington Research Center
Arlington, Texas, United States
North Texas Center for Clinical Research
Frisco, Texas, United States
CCS Texas
Houston, Texas, United States
Countries
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Other Identifiers
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