Botulinum Toxin for Scarring
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether botulinum toxin (also known as Botox or OnabotulinumtoxinA) can reduce scarring after skin biopsies. Participants will receive botulinum toxin treatment on one biopsy site and a placebo (saline solution) on another, enabling researchers to compare scar formation. The trial is designed for healthy individuals who can commit to follow-up visits and do not have a history of severe scarring or certain medical conditions like myasthenia gravis. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that botulinum toxin is safe for treating scars. Studies have found it well-tolerated and effective in reducing scar size and visibility. One study found that botulinum toxin improved scar appearance more than saline or no treatment. Another review confirmed its safety and effectiveness in scar management. For those considering a clinical trial for botulinum toxin in scar treatment, previous research indicates promising safety data.12345
Why do researchers think this study treatment might be promising for scarring?
Researchers are excited about using botulinum toxin for scarring because it offers a completely different approach compared to standard treatments like silicone sheets or corticosteroid injections. Botulinum toxin works by temporarily paralyzing muscles, which can reduce tension on the wound and potentially lead to less noticeable scars. This approach targets the underlying muscle activity that can worsen scarring, rather than just treating the skin's surface. Additionally, the toxin is administered directly into the suture line, allowing precise application to the area most at risk for scarring.
What evidence suggests that Botulinum Toxin might be an effective treatment for scarring?
Research shows that botulinum toxin type A (BTA) can help reduce scar formation. Studies have found that BTA improves the appearance of scars and prevents them from widening, making them less noticeable. In this trial, one biopsy site will receive BTA injections, while the other will receive a placebo. A meta-analysis, which examined results from several studies, found that BTA injections were more effective than a placebo in improving scars. BTA has also successfully prevented severe scars after surgery. This evidence suggests that BTA could be a promising treatment for scars from wounds like biopsies.46789
Who Is on the Research Team?
David Ozog, MD
Principal Investigator
Henry Ford Health Systems
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either botulinum toxin or placebo injections into biopsy sites
Follow-up
Participants are monitored for scar formation and healing using the Modified Patient and Observer Scar Assessment Scale
What Are the Treatments Tested in This Trial?
Interventions
- Botulinum Toxin
- Normal saline
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Botulinum Toxin is already approved in United States, European Union, Canada for the following indications:
- Facial wrinkles
- Blepharospasm
- Strabismus
- Axillary hyperhidrosis
- Migraine prophylaxis
- Overactive bladder
- Neurogenic detrusor overactivity
- Facial wrinkles
- Blepharospasm
- Strabismus
- Axillary hyperhidrosis
- Migraine prophylaxis
- Overactive bladder
- Neurogenic detrusor overactivity
- Spasticity
- Facial wrinkles
- Blepharospasm
- Strabismus
- Axillary hyperhidrosis
- Migraine prophylaxis
- Overactive bladder
- Neurogenic detrusor overactivity
- Spasticity
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor
Citations
Effects of botulinum toxin type A in the prevention and ...
In summary, BTX‐A demonstrates effective prevention and treatment of facial hypertrophic scars, alleviating scar pain and hindering scar widening. However, ...
The effect of botulinum toxin injection dose on ...
In the present study, the results show that the high dose of BTxA was more effective than the low dose in the management of scar hypertrophy.
Efficacy of Botulinum Toxin Type A in Improving Scar Quality ...
This meta-analysis of RCTs provides reliable evidence that BTA injection is superior to placebo or blank control group in improving scar quality and wound ...
The Efficacy of Botulinum Toxin Type A (BTA) in ...
Botulinum toxin type A (BTA) has shown promising outcomes in reducing scar formation. Research suggested its effectiveness in managing ...
Efficacy of Botulinum Toxin Type A for Prevention of Post- ...
BoNT-A has demonstrated effectiveness in scar prevention by reducing the severity of postoperative scar formation and improving overall scar appearance.
Botulinum Toxin Type A for Preventing Facial Trauma and ...
The results indicate that injecting botulinum toxin A around the wound can reduce the width of facial and neck scars, as shown in Figure 7.
7.
journals.lww.com
journals.lww.com/plasreconsurg/abstract/9900/efficacy_of_botulinum_toxin_type_a_in_the.2917.aspxEfficacy Of Botulinum Toxin Type A In The Prevention Of...
BoNT-A showed significant improvements in several outcomes. For the VSS, the MD was -1.07 (95% CI: -1.59 to -0.56; p < 0.0001), whereas for the ...
A Meta‐Analysis of the Efficacy and Safety of Botulinum ...
Botulinum toxin is effective and safe in postoperative scar management. The results of the meta-analysis showed that botulinum toxin could ...
The safety and efficacy of botulinum toxin for management ...
Our results indicate that injection of botulinum toxin is safe and effective, and benefits scars more than placebo (saline) or no treatment. VSS scores more ...
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