NCT06524323

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 1:1 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.

Conditions

• Nodular Prurigo

Interventions

Type	Name	Description
DRUG	5-fluorouracil Injection	The mixture contains 2mL of triamcinolone acetonide injection and 4mL of 5-fluorouracil injection, which is diluted with saline to 10mL.
DRUG	Triamcinolone Acetonide	The mixture contains 2mL of triamcinolone acetonide injection which is diluted with saline to 10mL.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2024-07-29
• Last updated: 2024-07-29

Locations

1 site across 1 country: China