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COMPLETED Early Phase 1

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

NCT05330078 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Botulinum toxin type A
  • DRUG Vehicle

Study Locations (1)

California

  • University of California San Diego — San Diego

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2022-03-11
Est. Completion 2023-05-31
Phase Early Phase 1

Sponsor

University of California, San Diego

823 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05330078

The ClinicalTrials.gov registry entry for NCT05330078 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 823 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Keloid appearing as the primary indexed condition, and to 2 interventions — of which Botulinum toxin type A is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05330078 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05330078 about?

NCT05330078 is a clinical study titled "Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids". 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 treatme...

What is the current status of trial NCT05330078?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2022-03-11. Estimated completion is 2023-05-31.

What conditions does trial NCT05330078 study?

This clinical trial studies the following conditions: Keloid. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05330078?

The interventions under investigation include: Botulinum toxin type A (DRUG), Vehicle (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05330078?

This trial is sponsored by University of California, San Diego, which has 823 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05330078 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial