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ACTIVE NOT RECRUITING
NCT04582383
PHASE4

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

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

DRUG

Spironolactone

Dispensation of spironolactone according to the arm description.

DRUG

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