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Neurotoxin

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
Healthy Individuals age 18 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years or older and in good health.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
299 Previous Clinical Trials
2,098,735 Total Patients Enrolled
2 Trials studying Scarring
43 Patients Enrolled for Scarring
David Ozog, MDPrincipal InvestigatorHenry Ford Health Systems
4 Previous Clinical Trials
72 Total Patients Enrolled
3 Trials studying Scarring
52 Patients Enrolled for Scarring

Media Library

Botulinum Toxin (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05478551 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I possibly qualify to join this clinical trial?

"The study team is looking for 12 individuals, aged 18 to 70, who currently have hypertrophy to participate. Additionally, all potential patients must meet the following: Be a healthy individual age 18 or older, Understand the requirements of the study and its associated risks, Be able to complete and sign a consent form."

Answered by AI

Does this experiment only include those who are 50 and over?

"Patients that fall between 18-70 years old are eligible for this study. If a patient is too young (under 18) or too old (over 65), there are 10 and 49 other trials respectively that they may be able to enroll in."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~4 spots leftby Mar 2025