RECRUITING

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-30
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04582383

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.

Ages Eligible for Study:16 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female sex assigned at birth
  2. * Age 16-40 years old
  3. * 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
  4. * Not currently pregnant or planning to become pregnant
  1. * Pregnancy
  2. * Heart disease
  3. * Renal disease
  4. * Liver disease
  5. * Orthostatic hypotension
  6. * Addison's disease
  7. * History of hyperkalemia
  8. * Allergy to tetracycline-class antibiotic
  9. * Allergy to spironolactone
  10. * 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.
  11. * Treatment with spironolactone, an oral antibiotic, laser, photodynamic therapy, or chemical peel within the past 4 weeks
  12. * Treatment with isotretinoin within the past 3 months
  13. * Sebacia laser treatment within the past 12 months

Contacts and Locations

Study Contact

David J Margolis, MD, PhD
CONTACT
215-662-2590
margo@pennmedicine.upenn.edu
John S Barbieri, MD, MBA
CONTACT
6172645932
jbarbieri@bwh.harvard.edu

Study Locations (Sites)

Johnson Dermatology
Fort Smith, Arkansas, 72916
United States
University of California San Francisco
San Francisco, California, 94115
United States
University of Miami
Miami, Florida, 33136
United States
New Horizon Research Center
Miami, Florida, 33165
United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46250
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dermatologists of Central States
Cincinnati, Ohio, 45242
United States
Ohio State University Medical Center
Columbus, Ohio, 43215
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 45209
United States
North Texas Center for Clinical Research
Frisco, Texas, 75034
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-30
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2022-03-30
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • spironolactone
  • doxycycline

Additional Relevant MeSH Terms

  • Acne