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

NCT05478551 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

  • Scar
  • Hypertrophic Scar

Interventions

DRUG

Botulinum Toxin

We will be comparing botulinum toxin following the biopsies to placebo injection. We will then compare photos of each biopsy site at set intervals following the procedure.

DRUG

Normal saline

Normal saline will serve as the placebo control on the contralateral side of the back.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • David Ozog, MD · Henry Ford Health Systems

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05478551 on ClinicalTrials.gov