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Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
Sponsor: University of Pennsylvania
Summary
Acne is common illness of adolescents and young adults which is associated with substantial morbidity. While topical treatments are often sufficient for mild acne, moderate to severe acne often requires treatment with systemic medications such as oral antibiotics, hormonal therapies such spironolactone, and isotretinoin. Sebum overproduction is fundamental to the pathogenesis of acne with associated disordered keratinization and subsequent microbial colonization and inflammation resulting in the clinical manifestations of acne. Given the influence of hormones on sebum production, therapies that address these underlying hormonal factors such as spironolactone and oral contraceptive pills represent an underutilized treatment option for women with acne and could help decrease the use of long-term oral antibiotics in this patient population. The purpose of this trial is to evaluate the comparative effectiveness of spironolactone versus doxycycline hyclate (tetracycline class antibiotic) for women with acne.
Official title: A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women
Key Details
Gender
FEMALE
Age Range
16 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2022-03-30
Completion Date
2026-07-31
Last Updated
2026-03-06
Healthy Volunteers
Yes
Conditions
Interventions
Spironolactone
Dispensation of spironolactone according to the arm description.
Doxycycline Hyclate
Dispensation of doxycycline hyclate according to the arm description.
Locations (18)
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