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

NCT ID: NCT05330078

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Keloid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type 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 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.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Vehicle

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

Other Intervention Names

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vehicle control (saline)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Arisa Ortiz

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California San Diego

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31006769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28818530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25810045 (View on PubMed)

Other Identifiers

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201088

Identifier Type: -

Identifier Source: org_study_id