Comparing spironolactone and doxycycline for treating acne
A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women
This study tests whether spironolactone works better than doxycycline for treating moderate to severe acne in women aged 16 to 40.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 18 sites (Fort Smith, Arkansas and 17 other locations) |
| Trial ID | NCT04582383 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of spironolactone compared to doxycycline in treating moderate to severe acne in women aged 16-40. Acne is a common condition that can significantly impact quality of life, and this study aims to explore hormonal therapies as an alternative to long-term antibiotic use. Participants will be assessed based on their acne severity and response to treatment over the course of the trial. The goal is to determine which medication provides better outcomes for patients suffering from acne.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 16-40 with moderate to severe acne characterized by at least 10 inflammatory lesions.
Not a fit: Patients who are pregnant, have certain medical conditions, or have recently undergone specific acne treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women with moderate to severe acne, potentially reducing reliance on long-term antibiotics.
How similar studies have performed: Other studies have explored hormonal treatments for acne, but this specific comparison of spironolactone and doxycycline is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Fort Smith, Arkansas and 17 other locations
- Johnson Dermatology — Fort Smith, Arkansas, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Completed)
- Cura Clinical Research — Sherman Oaks, California, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- New Horizon Research Center — Miami, Florida, United States (Completed)
- Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States (Completed)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Northwell Health — N. New Hyde Park, New York, United States (Recruiting)
- New York University — New York, New York, United States (Recruiting)
- Dermatologists of Central States — Cincinnati, Ohio, United States (Recruiting)
- Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)
- Cyn3rgy Research — Gresham, Oregon, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Completed)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Arlington Research Center — Arlington, Texas, United States (Recruiting)
- North Texas Center for Clinical Research — Frisco, Texas, United States (Recruiting)
- CCS Texas — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: David J Margolis, MD, PhD
- Email: margo@pennmedicine.upenn.edu
- Phone: 215-662-2590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.