NCT05330078

Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Keloids are a common form of hypertrophic scars that by definition last beyond 6 months and grow beyond the site of initial injury. Keloids are a common complaint from patients in dermatology and cause significant functional impairment due to cosmetic disfigurement, itching and pain. Current treatment modalities include intralesional corticosteroids, chemotherapeutic agents and laser therapy. 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 symptoms while having fewer side effects when compared to intralesional corticosteroid injection, which can cause unnatural blood vessel growth or skin thinning. To date, no study has carefully examined the efficacy of Botulinum toxin type A in treating keloids or its mechanistic effects on keloid biology. Our aim in this study is to pursue a rigorous, randomized control trial to assess the potential use Botulinum toxin type A to treat keloids. Efficacy will be objectively be mentioned by change in keloid size after treatment, along with subjective measures of patient satisfaction and symptoms, and finally physician rated scores. Also, samples from three patients will be analyzed in the laboratory setting to determine the underlying molecular mechanism behind the effects of Botulinum toxin type A on keloid biology.

Conditions

• Keloid

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A	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.
DRUG	Vehicle	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.

Timeline

• Start date: 2022-03-11
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2022-04-15
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study