NCT05330078

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

Completed EARLY_PHASE1 Last updated 6 November 2025

What this trial tests

EARLY_PHASE1 trial testing Botulinum toxin type A in Keloid in 10 participants. Completed in 31 May 2023.

Timeline

11 March 2022

Primary endpoint
31 May 2023

31 May 2023

Quick facts

Lead sponsor	University of California, San Diego
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	10
Start date	11 March 2022
Primary completion	31 May 2023
Estimated completion	31 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Botulinum toxin type A (BOTULINUM TOXIN TYPE A) — full drug profile →
• Vehicle

Conditions studied

• Keloid — all drugs for Keloid →

Sponsor

University of California, San Diego

Who can join

Adults 18 to 80, any sex, with Keloid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Current State of Clinical Trials for Keloid Management: An Analysis of Trials Registered on ClinicalTrials.gov.
   Park S, Li D, Guo L, Xu X. · · 2026 · PMID 42077711 · DOI 10.7759/cureus.106243