๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-24

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne (NCT04582383)

A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women

๐Ÿ”ต Active, Not Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: University of Pennsylvania

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Johnson Dermatology โ€” Fort Smith, Arkansas

Age range: 16 Years to 40 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (18 Sites)

  • Johnson Dermatology โ€” Fort Smith, Arkansas
  • University of California San Francisco โ€” San Francisco, California
  • Cura Clinical Research โ€” Sherman Oaks, California
  • University of Miami โ€” Miami, Florida
  • New Horizon Research Center โ€” Miami, Florida
  • Dawes Fretzin Clinical Research Group โ€” Indianapolis, Indiana
  • Brigham and Women's Hospital โ€” Boston, Massachusetts
  • New York University โ€” New York, New York
  • Northwell Health โ€” North New Hyde Park, New York
  • Dermatologists of Central States โ€” Cincinnati, Ohio
  • Ohio State University Medical Center โ€” Columbus, Ohio
  • Cyn3rgy Research โ€” Gresham, Oregon
  • Oregon Health and Science University โ€” Portland, Oregon
  • Children's Hospital of Philadelphia โ€” Philadelphia, Pennsylvania
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • Arlington Research Center โ€” Arlington, Texas
  • North Texas Center for Clinical Research โ€” Frisco, Texas
  • CCS Texas โ€” Houston, Texas

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Acne clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—