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NCT05330078 · ClinicalTrials.gov registry record · Early Phase 1
Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
A Early Phase 1 study of Keloid, sponsored by University of California, San Diego.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05330078 is a Early Phase 1 study of Keloid that has completed, run by University of California, San Diego. The registered enrollment target is 10 participants, below the 2,143-participant average among 8 other Keloid trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05330078, a Early Phase 1 study of Keloid, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2023-05-31 |
| Phase | Early Phase 1 |
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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, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,143-participant average among 8 other Keloid trials with a reported enrollment target (100% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
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.
NCT05330078 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
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.
What interventions are being tested in trial NCT05330078?
The interventions under investigation include: Botulinum toxin type A (DRUG), Vehicle (DRUG).
Who is sponsoring clinical trial NCT05330078?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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