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A Randomized, Double-blinded, Self-controlled Clinical Study of Intralesional Injection of 5-fluorouracil Plus Triamcinolone for the Treatment of Refractory Nodular Prurigo

NCT06524323 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-29

No results posted yet for this study

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.

Conditions

  • Nodular Prurigo

Interventions

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524323 on ClinicalTrials.gov