Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
SD-ACNE
A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women
1 other identifier
interventional
350
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2022
Longer than P75 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedStudy Start
First participant enrolled
March 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedMarch 6, 2026
March 1, 2026
3.9 years
September 30, 2020
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change in inflammatory lesion count
Difference in change in inflammatory lesion count between those randomized to spironolactone versus doxycycline hyclate
Baseline to Week 16
Secondary Outcomes (6)
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
Change in comedonal lesions
Baseline to Week 8, and Week 16
Change in Acne-QoL, an acne-specific quality of life measure
Baseline to Week4, Week 8, Week 12, and Week 16
Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure
Baseline to Week4, Week 8, Week 12, and Week 16
Patient global assessment
Baseline to Week4, Week 8, Week 12, and Week 16
- +1 more secondary outcomes
Study Arms (2)
Spironolactone
EXPERIMENTALIn 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.
Doxycycline hyclate
ACTIVE COMPARATORThis 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.
Interventions
Dispensation of doxycycline hyclate according to the arm description.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Johnson Dermatology
Fort Smith, Arkansas, 72916, United States
University of California San Francisco
San Francisco, California, 94115, United States
Cura Clinical Research
Sherman Oaks, California, 92866, 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
New York University
New York, New York, 10016, United States
Northwell Health
North New Hyde Park, New York, 11042, United States
Dermatologists of Central States
Cincinnati, Ohio, 45242, United States
Ohio State University Medical Center
Columbus, Ohio, 43215, United States
Cyn3rgy Research
Gresham, Oregon, 97030, 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
Arlington Research Center
Arlington, Texas, 76011, United States
North Texas Center for Clinical Research
Frisco, Texas, 75034, United States
CCS Texas
Houston, Texas, 77004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 9, 2020
Study Start
March 30, 2022
Primary Completion
February 13, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 1 year following study completion
IPD will be available to research teams within 1 year following study completion.