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NCT04582383 · ClinicalTrials.gov registry record · Phase 4
Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
A Phase 4 study of Acne, sponsored by University of Pennsylvania.
- Active
- Registry status
- Phase 4
- Development phase
- 350
- Enrollment target
- 18
- Study locations
NCT04582383: Active Phase 4 study of Acne, sponsored by University of Pennsylvania.
NCT04582383 is a Phase 4 study of Acne that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 350 participants, above the 129-participant average among 26 other Acne trials with a reported enrollment target (171% higher). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04582383, a Phase 4 study of Acne, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 350 participants
- Enrollment target
- 18
- Study locations
Study 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.
Primary Outcome
Difference in change in inflammatory lesion count between those randomized to spironolactone versus doxycycline hyclate
Conditions Studied
Interventions
- DRUG Spironolactone
- DRUG Doxycycline Hyclate
Study Locations (18)
Texas
- Arlington Research Center - Arlington
- North Texas Center for Clinical Research - Frisco
- CCS Texas - Houston
California
- University of California San Francisco - San Francisco
- Cura Clinical Research - Sherman Oaks
Florida
- University of Miami - Miami
- New Horizon Research Center - Miami
New York
- New York University - New York
- Northwell Health - North New Hyde Park
Ohio
- Dermatologists of Central States - Cincinnati
- Ohio State University Medical Center - Columbus
Oregon
- Cyn3rgy Research - Gresham
- Oregon Health and Science University - Portland
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- University of Pennsylvania - Philadelphia
Arkansas
- Johnson Dermatology - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 4 |
What the registry record for NCT04582383 still lists
NCT04582383 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 129-participant average among 26 other Acne trials with a reported enrollment target (171% higher).
The record links to 1 condition, with Acne appearing as the primary indexed condition, and to 2 interventions - of which Spironolactone is the first listed.
NCT04582383 lists 18 locations in 10 states (Texas, California, Florida).
Frequently Asked Questions
What is clinical trial NCT04582383 about?
NCT04582383 is a clinical study titled "Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne". 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 spironolact...
What is the current status of trial NCT04582383?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 350 participants. The study started on 2022-03-30. Estimated completion is 2026-07-31.
What conditions does trial NCT04582383 study?
This clinical trial studies the following conditions: Acne.
What interventions are being tested in trial NCT04582383?
The interventions under investigation include: Spironolactone (DRUG), Doxycycline Hyclate (DRUG).
Who is sponsoring clinical trial NCT04582383?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04582383 being conducted?
This trial has 18 study locations across Arkansas, California, Florida, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04582383's enrollment target sits among peer trials
350 3rd of 26 higher than 24 of 26 other Acne trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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