- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05330078
Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
May 2, 2023 updated by: Arisa Ortiz, University of California, San Diego
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92122
- University of California San Diego
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Keloid treatment with botulinum toxin type A
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 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.
|
Placebo Comparator: Keloid treatment with vehicle control (saline)
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Keloid volume
Time Frame: Measurements obtained at 0 and 24 weeks.
|
Keloid volume will be measured using the high resolution 3D imaging system (Cherry Imaging platform)
|
Measurements obtained at 0 and 24 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2022
Primary Completion (Anticipated)
January 1, 2032
Study Completion (Anticipated)
January 1, 2032
Study Registration Dates
First Submitted
March 16, 2022
First Submitted That Met QC Criteria
April 8, 2022
First Posted (Actual)
April 15, 2022
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 2, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Connective Tissue Diseases
- Fibrosis
- Cicatrix
- Collagen Diseases
- Keloid
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- 201088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Publication will be submitted in a peer reviewed journal.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keloid
-
CHA UniversityCompletedHypertrophic or Keloid ScarsKorea, Republic of
-
Queen Mary University of LondonWithdrawn
-
SolitonEmergent Clinical Consulting, LLCCompleted
-
Sensus HealthcareUnknownKeloid ScarUnited States
-
Sensus HealthcareUnknown
-
University of UlmCompleted
-
NYU Langone HealthCompleted
-
Northwestern UniversityCompleted
-
Our Lady of the Lake HospitalLouisiana State University Health Sciences Center in New OrleansCompletedPost-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of KeloidsKeloid | Keloid Scar Following SurgeryUnited States
-
Next Science TMJacksonville Center For Clinical ResearchWithdrawnKeloid Scar Following SurgeryUnited States
Clinical Trials on Botulinum toxin type A
-
AllerganTerminatedOveractive BladderSerbia, Turkey, Greece, Egypt, Lebanon, India
-
Daewoong Pharmaceutical Co. LTD.Completed
-
AllerganCompletedOveractive BladderPortugal, South Africa, Netherlands, Canada, Singapore, Brazil, United States, Taiwan, Italy, United Kingdom, France, Spain
-
AllerganCompletedOveractive BladderUnited Kingdom, Belgium, New Zealand, France, Russian Federation, Czech Republic, United States, Germany, Austria, Poland, Slovakia, Ukraine, Canada, Australia
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar RhytidesUnited States
-
HugelCompletedBenign Masseteric HypertrophyKorea, Republic of
-
Brazilan Center for Studies in DermatologyCompletedWrinkles in Frontal AreaBrazil
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar Rhytides | Frown Lines Between the EyebrowsUnited States
-
Medy-ToxCompletedCervical Dystonia
-
Seton Healthcare FamilyCompleted