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An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS)

Study acronym: EBShield
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Sep 2026 to Jun 10, 2026v27
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 36 → 30 locations
    v26
  3. Primary completion date: Mar 2026 to Sep 2026
    • Study completion date: Jan 2027 to Mar 2027
    • Study sites revised (36)
    v25
  4. Study sites: 35 to 36v24
  5. Eligibility criteria shortened, about 21 words
    • Site details revised at 4 of 35 sites
    v23
Show 21 earlier versionsHide 21 earlier versions
  1. Primary completion date: Aug 2025 to Mar 2026
    • Study sites: 33 to 35
    • Study completion date: Mar 2026 to Jan 2027
    v22
  2. Eligibility criteria expanded, about 21 wordsv21
  3. Study sites: 31 to 33v20
  4. Study sites: 29 to 31v19
  5. Study sites: 30 to 29
    • Eligibility criteria revised
    v18
  6. Study sites: 28 to 30v17
  7. Study sites: 27 to 28v16
  8. Site details revised at 2 of 27 sitesv15
  9. Site details revised at 3 of 27 sitesv14
  10. Study sites: 23 to 27v13
  11. Eligibility criteria revised
    • Secondary endpoints revised (5)
    • Site details revised at 1 of 23 sites
    v12
  12. Site details revised at 3 of 23 sitesv11
  13. Site details revised at 1 of 23 sitesv10
  14. Site contacts updated at 1 of 23 sitesv9
  15. Study sites: 22 to 23v8
  16. Site details revised at 1 of 22 sitesv7
  17. Site details revised at 4 of 22 sitesv6
  18. Site details revised at 1 of 22 sitesv5
  19. Study sites: 12 to 22
    • Start date changed from estimate of Apr 2024 to Apr 4, 2024
    v4
  20. Start date: Feb 2024 to Apr 2024
    • Study sites: 6 to 12
    v3
  21. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2023 to Feb 2024
    • Study sites: 0 to 6
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The proposed Phase 2/3 trial with double-blind and open-label extension phases is an international, multicenter study designed to assess the efficacy and safety of diacerein 1% ointment in patients with generalized EBS.
Trial Details
NCT Number NCT06073132
Lead Sponsor TWi Biotechnology, Inc.
Conditions
(from sponsor)		 Generalized Epidermolysis Bullosa Simplex
Related terms Epidermolysis Bullosa Simplex
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov