Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524323
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
A Randomized Double-blinded Self-controlled Clinical Study of Intralesional Injection of 5-fluorouracil Plus Triamcinolone for the Treatment of Refractory Nodular Prurigo
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blinded Self-controlled Clinical Study of Intralesional Injection of 5-fluorouracil Plus Triamcinolone for the Treatment of Refractory Nodular Prurigo
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nodular pruritus is a chronic inflammatory skin disease manifested as individual or multiple highly keratotic nodules with severe itching The goal of this clinical trial is to compare the efficacy and safety of treating refractory nodular pruritus with intralesional injections of 5-fluorouracil alone or 5-fluorouracil plus triamcinolone acetonide
Detailed Description:
The study is a single-center randomized double-blinded self-controlled clinical trial and is expected to enroll 60 patients The trial is set up with a self-control design comparing the two treated sides on the arms or legs with 11 interindividual randomization right side triamcinolone acetonide-alone left side 5-fluorouracil plus triamcinolone acetonide or the other way round Patients who meet all the inclusion criteria and do not meet any of the exclusion criteria are randomly enrolled and receive trial medication treatment All enrolled patients with receive intralesional injections of the trial medication once every 4 weeks for a total of 12 weeks For the first 4 weeks after the initial dose follow-up visits are scheduled every 2 weeks from weeks 5 to 12 follow-up visits are scheduled every 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None