Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04582383
• Other study ID #: R34AR074733-01A1
• Status: Recruiting
• Phase: Phase 4
• Start date: March 30, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: November 2023
• Source: University of Pennsylvania
• Contact: David J Margolis, MD, PhD
• Phone: 215-662-2590
• Email: margo[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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'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

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 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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• Spironolactone
Dispensation of spironolactone according to the arm description.
• Doxycycline Hyclate
Dispensation of doxycycline hyclate according to the arm description.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dermatologists of Central States	Cincinnati	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	North Texas Center for Clinical Research	Frisco	Texas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	New Horizon Research Center	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in inflammatory papules and pustules	Difference in change in inflammatory papules and pustules between those randomized to spironolactone versus doxycycline hyclate	Baseline to Week 16
Secondary	Percentage achieving Investigator Global Assessment (IGA) Success (IGA grade of clear or almost clear; grade 0 or 1)	Difference in percentage achieving IGA success between those randomized to spironolactone versus doxycycline hyclate	Baseline to Week 8, and Week 16
Secondary	Change in comedonal lesions	Difference in change in comedonal lesions between those randomized to spironolactone versus doxycycline hyclate	Baseline to Week 8, and Week 16
Secondary	Change in Acne-QoL, an acne-specific quality of life measure	Difference in change in Acne-QoL score between those randomized to spironolactone versus doxycycline hyclate. There are 4 subscales: self perception, scored 0-30; role social, scored 0-24; role-emotional, scored 0-30; and acne symptoms, scored 0-30. Higher scores indicate better quality of life.	Baseline to Week4, Week 8, Week 12, and Week 16
Secondary	Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure	Difference in change in DLQI score between those randomized to spironolactone versus doxycycline hyclate. Scores range from 0-30, with lower scores indicated better quality of life.	Baseline to Week4, Week 8, Week 12, and Week 16
Secondary	Patient global assessment	Difference in change in patient global assessment scores between those randomized to spironolactone versus doxycycline hyclate.	Baseline to Week4, Week 8, Week 12, and Week 16
Secondary	Percentage on any topical medication at baseline who discontinued at least one of these topical medications (i.e. topical retinoid, benzoyl peroxide, and topical antibiotic)	Difference between those randomized to spironolactone versus doxycycline hyclate	Baseline to Week 16