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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05330078
• Other study ID #: 201088
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: March 11, 2022
• Est. completion date: January 2032

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: January 2032
• Est. primary completion date: January 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.