Botulinum Toxin for Keloids
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Botulinum toxin type A, an injection treatment, can effectively treat keloids—thick, raised scars that cause discomfort and itching. Researchers aim to determine if this treatment reduces keloid size and improves symptoms compared to a saline placebo. Participants will receive injections in their keloids and will be monitored for changes. Individuals with a keloid scar at least 4 cm long, who haven't received keloid treatment in the past year, and are dissatisfied with their keloid may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on certain treatments like chemotherapy, radiation, or specific medications like dupilumab and aminoglycoside antibiotics during the study.
Is there any evidence suggesting that Botulinum toxin type A is likely to be safe for humans?
Research shows that Botulinum toxin type A might be a promising treatment for keloids, which are thick scars that can itch and cause discomfort. Studies have found that it can help reduce the size of these scars and relieve symptoms like itching. This treatment tends to have fewer side effects compared to other options, such as steroid injections, which can lead to skin thinning or unusual blood vessel growth.
Botulinum toxin type A has been used for other conditions, and its side effects are usually mild. Most people handle it well. A study on its use for scars, including keloids, showed it significantly improved scar appearance without serious side effects. Another study reported good to excellent results in patients, with no treatment failures.
Although researchers are still studying this treatment specifically for keloids, current evidence suggests it is safe and well-tolerated by many people.12345Why do researchers think this study treatment might be promising?
Most treatments for keloids involve surgical removal, steroid injections, or laser therapy, which can be effective but often lead to recurrence. Botulinum toxin type A is unique because it targets the underlying muscle tension that might contribute to keloid formation, relaxing the area and potentially reducing scar tissue. Unlike the standard treatments that focus on removing the keloid, this approach aims to change how the skin heals. Researchers are excited because this could lead to a longer-lasting reduction in keloid size and recurrence, offering a novel solution for patients.
What evidence suggests that Botulinum Toxin Type A might be an effective treatment for keloids?
Research has shown that Botulinum toxin type A (BTA), which participants in this trial may receive, can help reduce scar formation. Studies have found it effectively manages keloids by reducing their size and easing symptoms like itching and pain. In one study, patients described their results from BTA treatment as "excellent" to "good." Another study found that BTA greatly improved the appearance of scars. While more research is needed, early findings suggest BTA could be a safe and effective treatment for keloids.12345
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with keloid scars at least 4cm long, lasting over a year, and scoring ≥8 on the Vancouver Scar Scale. Participants must be in stable health and not have had any keloid treatments in the past year. Pregnant individuals, those with facial/neck/scalp keloids, botulinum toxin hypersensitivity, or certain medical conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Botulinum toxin type A or saline injections for keloid treatment, with 3 treatments spaced 6 weeks apart
Follow-up
Participants are monitored for changes in keloid volume and symptoms after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Botulinum Toxin Type A
Trial Overview
The study tests Botulinum toxin type A's effectiveness against keloids compared to a placebo (vehicle). It measures changes in scar size, patient satisfaction, symptoms relief and physician assessments. The trial randomly assigns participants to receive either the treatment or placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive Botulinum toxin type A 5 units / cm3 with injections of 0.2mL spaced evenly 1cm apart within the treatment area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites, 50 unit total) of the study drug. Patients will undergo 3 treatments, 6 weeks apart.
Participants will receive saline injections of 0.2mL spaced evenly 1cm apart within the placebo area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites) of the vehicle control (saline). Patients will undergo 3 treatments, 6 weeks apart.
Botulinum Toxin Type A is already approved in United States, European Union, Canada for the following indications:
- Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Temporary improvement in the appearance of moderate to severe facial wrinkles and folds
- Axillary hyperhidrosis
- Blepharospasm
- Strabismus
- Cervical dystonia
- Chronic migraine
- Overactive bladder
- Detrusor overactivity associated with a neurologic condition
- Glabellar lines
- Facial wrinkles and folds
- Axillary hyperhidrosis
- Blepharospasm
- Strabismus
- Cervical dystonia
- Chronic migraine
- Overactive bladder
- Detrusor overactivity associated with a neurologic condition
- Spasticity of the upper limb
- Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Temporary improvement in the appearance of moderate to severe facial wrinkles and folds
- Axillary hyperhidrosis
- Blepharospasm
- Strabismus
- Cervical dystonia
- Chronic migraine
- Overactive bladder
- Detrusor overactivity associated with a neurologic condition
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Published Research Related to This Trial
Citations
The Efficacy of Botulinum Toxin Type A (BTA) in the Treatment ...
Botulinum toxin type A (BTA) has shown promising outcomes in reducing scar formation. Research suggested its effectiveness in managing ...
The use of botulinum toxin in keloid scar management
Therapeutic outcomes were recorded as excellent in three, good in five, and fair in four patients (no treatment failure). Patient satisfaction was noted as ...
Examining the Therapeutic Potential of Botulinum Toxin ...
Initial reports have demonstrated that Botulinum toxin type A may be a viable treatment option for keloids that can reduce keloid size and reduce associated ...
Evaluation of botulinum toxin type A for treating post burn ...
The aim of this study is to evaluate the efficacy and safety of botulinum toxin type A in treatment of post burn hypertrophic and keloid scars in children.
Efficacy and safety of sequential treatment with botulinum ...
Our analysis showed that the combined therapy significantly outperformed monotherapy in improving Vancouver scar scale scores (P < 0.05) and in ...
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