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Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Study acronym: SD-ACNE
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv16
  2. Completion pushed from Jul 31, 2026 to Jul 31, 2027 Primary completion date: Feb 13, 2026 to Feb 14, 2026v15 Show 1 more changeShow less
    • Primary completion date: Feb 13, 2026 to Feb 14, 2026
  3. Primary completion date changed from estimate of Feb 17, 2026 to Feb 13, 2026v14
  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 18 of 18 sitesv13 Show 1 more changeShow less
    • Site details revised at 18 of 18 sites
  5. Primary endpoint revisedv12 See this version in full on ClinicalTrials.gov ↗
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Jan 20, 2026 to Feb 17, 2026v11
  2. Study sites: 12 to 18 Primary completion date: Dec 17, 2025 to Jan 20, 2026v10 Show 1 more changeShow less
    • Primary completion date: Dec 17, 2025 to Jan 20, 2026
  3. Enrollment target: 400 to 350v9
  4. Primary completion date: Jul 31, 2025 to Dec 17, 2025v8
  5. Study sites: 10 to 12 Eligibility criteria shortened, about 8 wordsv7 Show 1 more changeShow less
    • Eligibility criteria shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 5 to 10v6
  7. Primary completion date: Dec 30, 2025 to Jul 31, 2025 Completion date: Dec 30, 2026 to Jul 31, 2026 · Start date: Mar 1, 2022 to Mar 30, 2022v5 Show 2 more changesShow less
    • Completion date: Dec 30, 2026 to Jul 31, 2026
    • Start date: Mar 1, 2022 to Mar 30, 2022
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 5v4 Show 1 more changeShow less
    • Study sites: 1 to 5
  9. Start date: Dec 1, 2021 to Mar 1, 2022v3
  10. Primary completion date: Jun 30, 2025 to Dec 30, 2025 Start date: Jul 1, 2021 to Dec 1, 2021 · Completion date: Jun 30, 2026 to Dec 30, 2026 · Eligibility criteria expanded, about 3 wordsv2 Show 3 more changesShow less
    • Start date: Jul 1, 2021 to Dec 1, 2021
    • Completion date: Jun 30, 2026 to Dec 30, 2026
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04582383
Lead Sponsor University of Pennsylvania
Conditions Acne
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov