Status:
COMPLETED
Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
Lead Sponsor:
University of California, San Diego
Conditions:
Keloid
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
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 caus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05330078
Start Date
March 11 2022
End Date
May 31 2023
Last Update
November 6 2025
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92122