search
Back to results

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

Primary Purpose

Keloid

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin type A
Vehicle
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Keloid treatment with botulinum toxin type A

Keloid treatment with vehicle control (saline)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Keloid volume
Keloid volume will be measured using the high resolution 3D imaging system (Cherry Imaging platform)

Secondary Outcome Measures

Full Information

First Posted
March 16, 2022
Last Updated
May 2, 2023
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT05330078
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
January 2032 (Anticipated)
Study Completion Date
January 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Keloid treatment will be randomized. Participants will not be informed of which side will be treated with botulinum toxin type A vs vehicle control (saline). Blinded physician evaluators will not have access to information regarding keloid treatment.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Keloid treatment with botulinum toxin type A
Arm Type
Experimental
Arm Description
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.
Arm Title
Keloid treatment with vehicle control (saline)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
vehicle control (saline)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Keloid volume
Description
Keloid volume will be measured using the high resolution 3D imaging system (Cherry Imaging platform)
Time Frame
Measurements obtained at 0 and 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Publication will be submitted in a peer reviewed journal.
Citations:
PubMed Identifier
31006769
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.
Results Reference
background
PubMed Identifier
28818530
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.
Results Reference
background
PubMed Identifier
25810045
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs