Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05330078
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-03
First Post:
2022-03-16
Brief Title:
Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None