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Randomized Controlled Trial Examining the Efficacy of Botulinum Toxin in Biopsy Scar Minimization

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Oct 28, 2023 to Dec 30, 2026
    • Trial status: Completed to Active, Not Recruiting
    v7
  2. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Dec 30, 2024 to Oct 28, 2023
    v6
  3. Primary completion date: Dec 2023 to Dec 30, 2024
    • Study completion date: Jun 2024 to Dec 30, 2024
    v5
  4. Primary completion date: Jun 2023 to Dec 2023
    • Study completion date: Feb 2024 to Jun 2024
    v4
  5. Primary completion date: Feb 2023 to Jun 2023v3
  6. Study Status, Study Design, Arms and Interventions, Eligibilityv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study seeks to evaluate the scar reduction capacity of BTA on excision/biopsy wounds compared to the control (normal saline) in a double-blinded randomized control trial. It will expand upon previous studies that have already demonstrated the safety and good tolerance profile of BTA. We will be conducting a split-scar study/study involving two biopsy sites in a singular patient, allowing them to serve as their own control. In keeping with the results from previously conducted studies, we hypothesize that the wounds treated with BTA will have significantly less evidence of scar formation than those sites treated with normal saline.
Trial Details
NCT Number NCT05478551
Lead Sponsor Henry Ford Health System
Conditions
(from sponsor)		 Scar, Hypertrophic Scar
Related terms Cicatrix, Cicatrix, Hypertrophic
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov