Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
Keloid
About this trial
This is an interventional treatment trial for Keloid
Eligibility Criteria
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
Sites / Locations
- University of California San Diego
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Keloid treatment with botulinum toxin type A
Keloid treatment with vehicle control (saline)
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.
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.