Botulinum Toxin for Scarring

Phase 2 & 3

Waitlist Available

Led By David Ozog, MD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial will test whether a new medication can reduce scarring compared to using no medication. The study will use two biopsy sites on each person, so that each person serves as their own control. The study hypothesis is that the new medication will lead to less scarring.

Who is the study for?

This trial is for healthy adults over 18 who can understand and consent to the study. It's not for those with a history of severe scarring, recent botulinum toxin injections in the treatment area, allergies to botulinum toxin, pregnant or breastfeeding individuals, or those with certain neuromuscular diseases.

What is being tested?

The study tests if Botulinum Toxin (BTA) reduces scars better than saline after biopsy wounds. Participants will have two biopsy sites; one treated with BTA and the other with saline, serving as their own control in this double-blinded study.

What are the potential side effects?

While previous studies show that BTA is generally safe and well-tolerated, potential side effects may include localized pain, swelling at injection sites, muscle weakness near treated areas or flu-like symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Botulinum toxinExperimental Treatment1 Intervention

Biopsy site receiving botulinum toxin Following the biopsy closures, one of two biopsy sites (left or right) will be selected to receive 30u (0.3cc) of botulinum toxin injected into the suture line at a depth of PPD bleb. The treatment for each wound site will be randomized (left versus right) and blinded but consistent throughout dosing.

Group II: PlaceboPlacebo Group1 Intervention

Placebo Comparator: Biopsy site receiving placebo Following the biopsy closures, the other biopsy site will receive 30u (0.3cc) of bacteriostatic normal saline injected into the suture line at a depth of PPD bleb.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Botulinum Toxin

2014

Completed Phase 4

~150

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