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

  • End date
    Jan 2, 2032
  • participants needed
  • sponsor
    University of California, San Diego
Updated on 2 May 2022
botulinum toxin
laser therapy
drug test
botulinum toxin type a
Accepts healthy volunteers


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.

Condition Keloid
Treatment Botulinum Toxin Type A, Vehicle
Clinical Study IdentifierNCT05330078
SponsorUniversity of California, San Diego
Last Modified on2 May 2022


Yes No Not Sure

Inclusion Criteria

Adults aged 18 to 80
History of keloid scar for at least 12 months
Absence of keloid treatment for past 12 months
Participant must have a keloid scar of at least 4cm in length
Participants who score at least 8 or higher on the Vancouver Scar Scale
Subjects who score 5 (neither satisfied nor dissatisfied) to 10 (maximally dissatisfied) on the patient subjective score of dissatisfaction with keloid
Participants must be in stable health, as confirmed by medical history, per investigator judgment
Participants must be able to read, sign, and understand the informed consent
Participants must be willing to avoid any other treatments to the keloid that will be treated including corticosteroid injections, surgical excision, chemotherapeutic injection, lasers, light-based therapy, radiation therapy, cryotherapy, or pressure therapy, during the study period

Exclusion Criteria

Pregnant women
Keloids on face, neck or scalp
History of hypersensitivity to botulinum toxin
Ongoing or planned treatment with chemotherapy, radiation, isotretinoin, cytokine-based immunotherapies
Any planned surgery during study period
Known diagnosis of insulin dependent diabetes mellitus
Patients being treating with dupilumab for any indication
Patients taking aminoglycoside antibiotics
Patients with pre-existing neuromuscular disorders
Patients with infection around potential injection sites
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