Summary

Eligibility
for people ages 18-80 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Arisa Ortiz (ucsd)
Headshot of Arisa Ortiz
Arisa Ortiz

Description

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.

Keywords

Keloid, Botulinum Toxins, Type A Botulinum Toxins, abobotulinumtoxinA, Botulinum toxin type A, Vehicle

Eligibility

Location

  • University of California San Diego
    San Diego California 92122 United States

Lead Scientist at University of California Health

  • Arisa Ortiz (ucsd)
    Clinical Professor, Dermatology, Vc-health Sciences-schools. Authored (or co-authored) 41 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05330078
Phase
Phase 1 Keloid Research Study
Study Type
Interventional
Participants
About 10 people participating
Last Updated