Clinical trial NCT05330078: Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
Official title: Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Keloid
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single center, randomized, single-masked, prospective experimental study. Half the keloid tissue will be treated with Botulinum toxin type A while the other half will be treated with a vehicle control (saline) of matching number of injections and volume. All treated keloids will serve as their own internal control. The treatment and control sides of the keloid will clearly be documented in the patient's chart and source documents to allow the study physician to track treatment vs vehicle control portions of the keloid.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 to 80
2. History of keloid scar for at least 12 months
3. Absence of keloid treatment for past 12 months
4. Participant must have a keloid scar of at least 4cm in length.
5. Participants who score at least 8 or higher on the Vancouver Scar Scale
6. Subjects who score 5 (neither satisfied nor dissatisfied) to 10 (maximally dissatisfied) on the patient subjective score of dissatisfaction with keloid.
7. Participants must be in stable health, as confirmed by medical history, per investigator judgment
8. Participants must be able to read, sign, and understand the informed consent
9. 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:

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

Primary outcomes:
measure: Change in Keloid volume
timeFrame: Measurements obtained at 0 and 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
References:
citation: Bi M, Sun P, Li D, Dong Z, Chen Z. 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. Med Sci Monit. 2019 Apr 22;25:2950-2958. doi: 10.12659/MSM.916305.
citation: Cocco A, Albanese A. Recent developments in clinical trials of botulinum neurotoxins. Toxicon. 2018 Jun 1;147:77-83. doi: 10.1016/j.toxicon.2017.08.014. Epub 2017 Aug 14.
citation: Shaarawy E, Hegazy RA, Abdel Hay RM. Intralesional botulinum toxin type A equally effective and better tolerated than intralesional steroid in the treatment of keloids: a randomized controlled trial. J Cosmet Dermatol. 2015 Jun;14(2):161-6. doi: 10.1111/jocd.12134. Epub 2015 Mar 24.