Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Running, not enrolling · Phase 4

Conditions studied: Acne

In brief

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.

Key facts

Study ID

NCT04582383

Run by

University of Pennsylvania

People needed

350

Starts

2022-03-30

Expected to finish

2027-07-31

Last updated by the study team

2026-06-05

Who can join

Age: 16 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female sex assigned at birth
• 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

You may not qualify if…

• Pregnancy
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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