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

• Status: Active, not recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: abobotulinumtoxinA; Botulinum Toxins

Criteria

Inclusion Criteria:

Healthy Individuals age 18 and older Able to understand the requirements of the study and its associated risks Able to complete and sign a consent form

Exclusion Criteria:

Allergy to botulinum toxin Currently pregnant or breastfeeding Myasthenia gravis Previous injection of botulinum toxin in the specified treatment areas within 6 months prior to enrollment Unable to follow up 6 months after biopsy procedure Refusal to participate in the trial History of keloid or hypertrophic scars Eaton-Lambert Syndrome Amyopathic Lateral Sclerosis