Botulinum Toxin for Keloids

Overseen By Reid Oldenburg, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, San Diego

Must not be taking: Aminoglycosides, Dupilumab, Chemotherapy, others

Disqualifiers: Pregnancy, Facial keloids, Diabetes, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 18 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing Botox to see if it can help people with keloid scars. Keloids are tough scars that don't respond well to usual treatments and can cause discomfort. Botox might help by relaxing the tissue and reducing the scar's size and symptoms.

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.

What data supports the effectiveness of the drug Botulinum Toxin Type A for treating keloids?

Research shows that Botulinum Toxin Type A can significantly improve keloid and hypertrophic scars by reducing their appearance and improving skin quality. Studies found significant improvements in scar assessments and skin tissue quality after treatment, suggesting it can be an effective option for managing these types of scars. ^{1 2 3 4 5}

Is Botulinum Toxin Type A safe for humans?

Botulinum Toxin Type A is generally considered safe for humans, but some adverse reactions have been reported, such as headaches, drooping eyelids, and skin reactions like rash and swelling. Serious side effects, although rare, can include difficulty swallowing and breathing problems, so it's important to monitor for any unusual symptoms after treatment. ^{3 6 7 8 9}

How does the drug Botulinum Toxin Type A differ from other treatments for keloids?

Botulinum Toxin Type A is unique because it can reduce pain and itching associated with keloids by affecting nerve activity, and it may also help improve the appearance of scars by reducing muscle tension around them. Unlike traditional treatments like steroids, it has shown promising results in reducing keloid recurrence and improving scar quality without the side effects associated with steroids. ^{1 3 10 11 12}

Eligibility Criteria

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

History of keloid scar for at least 12 months

Participants who score at least 8 or higher on the Vancouver Scar Scale

I have a keloid scar that is at least 4cm long.

Exclusion Criteria

History of hypersensitivity to botulinum toxin

I am currently taking aminoglycoside antibiotics.

Patients with pre-existing neuromuscular disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Botulinum toxin type A or saline injections for keloid treatment, with 3 treatments spaced 6 weeks apart

18 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in keloid volume and symptoms after treatment

6 weeks

1 visit (in-person)

Treatment Details

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.

Participant Groups

Group I: Keloid treatment with botulinum toxin type A Experimental Treatment 1 Intervention

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.

Group II: Keloid treatment with vehicle control (saline) Placebo Group 1 Intervention

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:

Approved in United States as Botox for:

• 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

Approved in European Union as Botox for:

• 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

Approved in Canada as Botox for:

• 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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

Two cases of clinical botulism occurred in female patients after receiving botulinum toxin type A injections for cosmetic purposes, highlighting potential serious adverse reactions from these treatments.

Both patients showed clinical improvement after receiving botulinum antitoxin 7 and 9 days post-symptom onset, suggesting that antitoxin treatment may still be effective even when administered late.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed Antitoxin Treatment of Two Adult Patients with Botulism after Cosmetic Injection of Botulinum Type A Toxin. Fan, KL., Wang, YL., Chu, G., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of intralesional injection of botulinum toxin type A in hypertrophic scars and keloids: Clinical and pathological study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Botulinum Toxin on Improving Facial Surgical Scars: A Prospective, Split-Scar, Double-Blind, Randomized Controlled Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The use of botulinum toxin in keloid scar management: a literature review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Intralesional Injection of Botulinum Toxin Type A Compared with Intralesional Injection of Corticosteroid for the Treatment of Hypertrophic Scar and Keloid: A Systematic Review and Meta-Analysis. [2020]

5. India pubmed.ncbi.nlm.nih.gov

The Role of Chemoimmobilization in Improving the Outcome of Scar Revision Surgery. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Delayed Antitoxin Treatment of Two Adult Patients with Botulism after Cosmetic Injection of Botulinum Type A Toxin. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Current Research of Botulinum Toxin Type A in Prevention and Treatment on Pathological Scars. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Skin Toxicities Associated with Botulin Toxin Injection for Aesthetic Procedures: Data from the European Spontaneous Reporting System. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Botulinum Toxin Type A Injections in Improving Facial Scars: A Systematic Review and Meta-Analysis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Treatment of a painful keloid with botulinum toxin type A. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Treatment of Keloid Scars with Botulinum Toxin Type A versus Triamcinolone in an Athymic Nude Mouse Model. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Microneedle delivery of botulinum toxin type A combined with hyaluronic acid for the synergetic management of multiple sternal keloids with oily skin: A retrospective clinical investigation. [2023]