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ACTIVE NOT RECRUITING Phase 4

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

NCT04582383 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 350 participants
Start Date 2022-03-30
Est. Completion 2026-07-31
Phase Phase 4

Sponsor

University of Pennsylvania

1,457 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04582383

The ClinicalTrials.gov registry entry for NCT04582383 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04582383 reports 18 study locations spanning 10 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04582383?

The interventions under investigation include: Spironolactone (DRUG), Doxycycline Hyclate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04582383?

This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial