Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230146
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-12-22
Brief Title:
Efficacy and Safety of Fractional CO2 Laser Combined With Intralesional Insulin Botulinum Toxin or Triamcinolone Acetonide in the Treatment of Keloid A Clinical Dermoscopic and Immunohistochemical Study
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Efficacy and Safety of Fractional CO2 Laser Combined With Intralesional Insulin Botulinum Toxin or Triamcinolone Acetonide in the Treatment of Keloid A Clinical Dermoscopic and Immunohistochemical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 macroscopic cutaneous scarring that result from disturbance of wound healing that occurs on predisposed individuals
Keloid shows a kind of over-healing producing over abundant wound matrix responsible for raised inflexible red scar tissue that causes pain and itching
Keloid shows a kind of over-healing producing over abundant wound matrix responsible for raised inflexible red scar tissue that causes pain and itching
Detailed Description:
Multiple hypotheses have been proposed for keloid formation Though the pathogenesis of keloids is not fully understood it involves the dysregulation of complex inflammatory pathways
Several studies reported that IGF-IR was overexpressed in keloid fibroblasts Current treatment options include intralesional and topical therapies surgical interventions radiation and laser-based therapies
Intralesional corticosteroid is the most commonly used nonsurgical treatment for keloids Fractional laser combined triamcinolone acetonide with may minimize collagen production by decreasing fibroblast activity with a low recurrence rate of 154 which is superior to each modality
In recent years physicians were using botulinum toxin A BTX-A as a modality for prevention and treatment of keloids Botulinum toxin type A isolated from Clostridium botulinum is a potent neurotoxin that blocks neuromuscular transmission It has been shown to improve scar cosmesis by decreasing tension on healing wound edges
The role of topical insulin in wound healing has been under search in literature since 1970s
Zhang et al explored the effect of local insulin injection on systemic blood glucose level and wound healing in patients with diabetic foot ulcer
As far as the investigatorrs are aware this is the first study to assess the effectiveness and safety of intralesional insulin for the treatment of keloid
Several studies reported that IGF-IR was overexpressed in keloid fibroblasts Current treatment options include intralesional and topical therapies surgical interventions radiation and laser-based therapies
Intralesional corticosteroid is the most commonly used nonsurgical treatment for keloids Fractional laser combined triamcinolone acetonide with may minimize collagen production by decreasing fibroblast activity with a low recurrence rate of 154 which is superior to each modality
In recent years physicians were using botulinum toxin A BTX-A as a modality for prevention and treatment of keloids Botulinum toxin type A isolated from Clostridium botulinum is a potent neurotoxin that blocks neuromuscular transmission It has been shown to improve scar cosmesis by decreasing tension on healing wound edges
The role of topical insulin in wound healing has been under search in literature since 1970s
Zhang et al explored the effect of local insulin injection on systemic blood glucose level and wound healing in patients with diabetic foot ulcer
As far as the investigatorrs are aware this is the first study to assess the effectiveness and safety of intralesional insulin for the treatment of keloid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None