Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
- Registration Number
- NCT04582383
- Lead Sponsor
- University of Pennsylvania
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 350
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Doxycycline hyclate Doxycycline Hyclate This arm is an active-comparator arm in which participants will receive doxycycline hyclate 100mg/day for the entirety of the study. To maximize the generalizability of the study, participants will be allowed to continue their current topical regimen as long as no changes were made in the 4 weeks prior to randomization. No additions to their topical regimen may be made during the study period. Spironolactone Spironolactone In this arm, participants will receive spironolactone 100mg/day for the entirety of the study. To maximize the generalizability of the study, participants will be allowed to continue their current topical regimen as long as no changes were made in the 4 weeks prior to randomization. No additions to their topical regimen may be made during the study period.
- Primary Outcome Measures
Name Time Method Absolute change in inflammatory papules and pustules Baseline to Week 16 Difference in change in inflammatory papules and pustules between those randomized to spironolactone versus doxycycline hyclate
- Secondary Outcome Measures
Name Time Method Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure Baseline to Week4, Week 8, Week 12, and Week 16 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.
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) Baseline to Week 16 Difference between those randomized to spironolactone versus doxycycline hyclate
Percentage achieving Investigator Global Assessment (IGA) Success (IGA grade of clear or almost clear; grade 0 or 1) Baseline to Week 8, and Week 16 Difference in percentage achieving IGA success between those randomized to spironolactone versus doxycycline hyclate
Change in Acne-QoL, an acne-specific quality of life measure Baseline to Week4, Week 8, Week 12, and Week 16 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.
Patient global assessment Baseline to Week4, Week 8, Week 12, and Week 16 Difference in change in patient global assessment scores between those randomized to spironolactone versus doxycycline hyclate.
Change in comedonal lesions Baseline to Week 8, and Week 16 Difference in change in comedonal lesions between those randomized to spironolactone versus doxycycline hyclate
Trial Locations
- Locations (12)
Johnson Dermatology
🇺🇸Fort Smith, Arkansas, United States
North Texas Center for Clinical Research
🇺🇸Frisco, Texas, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Miami
🇺🇸Miami, Florida, United States
Dawes Fretzin Clinical Research Group
🇺🇸Indianapolis, Indiana, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Dermatologists of Central States
🇺🇸Cincinnati, Ohio, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States