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

NCT05330078 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 201088
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid

Outcome Measures

Primary Outcomes (1)

• Change in Keloid volume

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

  Measurements obtained at 0 and 24 weeks.

Study Arms (2)

Keloid treatment with botulinum toxin type A

EXPERIMENTAL

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.

Drug: Botulinum toxin type A

Keloid treatment with vehicle control (saline)

PLACEBO COMPARATOR

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.

Drug: Vehicle

Interventions

Botulinum toxin type A DRUG

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.

Keloid treatment with botulinum toxin type A

Vehicle DRUG

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.

Also known as: vehicle control (saline)

Keloid treatment with vehicle control (saline)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92122, United States

Location

Related Publications (3)

• 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.

  PMID: 31006769 BACKGROUND

• 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.

  PMID: 28818530 BACKGROUND

• 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.

  PMID: 25810045 BACKGROUND

MeSH Terms

Conditions

Keloid

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 15, 2022
• Study Start: March 11, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)