drugset / Trial / NCT05478551

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

NCT05478551

Phase 2/3 Active not recruiting 12 enrolled Henry Ford Health System
RandomizedParallel-groupTriple-blindPrevention

Summary

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.

Timeline

Start
2022-06-01
Primary completion
2026-12-30
Completion
2026-12-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin Protein / enzyme biologic 30 iu Other