NCT04582383

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 16 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Spironolactone	Dispensation of spironolactone according to the arm description.
DRUG	Doxycycline Hyclate	Dispensation of doxycycline hyclate according to the arm description.

Timeline

• Start date: 2022-03-30
• Primary completion: 2026-02-13
• Completion: 2026-07-31
• First posted: 2020-10-09
• Last updated: 2026-03-06

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study