Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Last updated: May 30, 2025
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

4

Condition

Rash

Scalp Disorders

Inflammatory Comedones

Treatment

Doxycycline Hyclate

Spironolactone

Clinical Study ID

NCT04582383
R34AR074733-01A1
  • Ages 16-40
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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'sGlobal Assessment (IGA) score of at least 2 as measured by the Comprehensive AcneSeverity Scale

  • Not currently pregnant or planning to become pregnant

Exclusion

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 doxycyclineor that may increase the risk for hyperkalemia, including angiotensin-convertingenzyme inhibitors, angiotensin receptor blockers, eplerenone, nonsteroidalanti-inflammatory drugs, and digoxin.

  • Treatment with spironolactone, an oral antibiotic, laser, photodynamic therapy, orchemical peel within the past 4 weeks

  • Treatment with isotretinoin within the past 3 months

  • Sebacia laser treatment within the past 12 months

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Doxycycline Hyclate
Phase: 4
Study Start date:
March 30, 2022
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94115
    United States

    Completed

  • Cura Clinical Research

    Sherman Oaks, California 92866
    United States

    Active - Recruiting

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Completed

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group

    Indianapolis, Indiana 46250
    United States

    Completed

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Northwell Health

    N. New Hyde Park, New York 11042
    United States

    Active - Recruiting

  • New York University

    New York, New York 10016
    United States

    Active - Recruiting

  • Dermatologists of Central States

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Cyn3rgy Research

    Gresham, Oregon 97030
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Penn State University (Hershey Medical Center)

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Completed

  • University of Pennsylvania

    Philadelphia, Pennsylvania 45209
    United States

    Active - Recruiting

  • Arlington Research Center

    Arlington, Texas 76011
    United States

    Active - Recruiting

  • North Texas Center for Clinical Research

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • CCS Texas

    Houston, Texas 77004
    United States

    Active - Recruiting

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