Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Description

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.

Conditions

Acne

Study Overview

Study Details

Study overview

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.

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

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Condition
Acne
Intervention / Treatment

-

Contacts and Locations

Fort Smith

Johnson Dermatology, Fort Smith, Arkansas, United States, 72916

San Francisco

University of California San Francisco, San Francisco, California, United States, 94115

Miami

University of Miami, Miami, Florida, United States, 33136

Miami

New Horizon Research Center, Miami, Florida, United States, 33165

Indianapolis

Dawes Fretzin Clinical Research Group, Indianapolis, Indiana, United States, 46250

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Cincinnati

Dermatologists of Central States, Cincinnati, Ohio, United States, 45242

Columbus

Ohio State University Medical Center, Columbus, Ohio, United States, 43215

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

16 Years to 40 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Pennsylvania,

Study Record Dates

2026-07-31