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Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.

NCT05106192 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-12

No results posted yet for this study

Summary

A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell lymphomas and cutaneous B-cell lymphomas in participants.

Conditions

  • Mycosis Fungoides of Skin (Diagnosis)
  • Cutaneous T-cell Lymphoma
  • Non Hodgkin Lymphoma
  • Lymphomatoid Papulosis
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Follicular

Interventions

DEVICE

Med-Jet Injector

The Med-Jet injector is a needle-free injection system that consists of a hand-held firing body/trigger, sterilized barrel, disposable luer lock syringe, disposable nozzle cap, and disposable splash guard. The Med-Jet injector is designed to deliver drugs or biologics into the intradermal, subcutaneous, or intramuscular tissues, by means of a narrow, high-velocity jet of fluid, which penetrates the surface of the skin and delivers the fluid to the target tissue

DRUG

Triamcinolone Acetonide

The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.20 ml of injected fluid).

DRUG

Bexarotene 1% Top Gel

Bexarotene can be applied up to four times daily according to patient tolerance directly to lesions. The gel is 1% bexarotene concentration.

DRUG

Nitrogen Mustard

Nitrogen mustard is applied once daily as patient tolerates. It is sold in a concentration of 0.016% gel.

DEVICE

Conventional syringe

A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Kevin Cooper, MD · Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2025-06-01
Completion
2026-06-01
FDA Device
Yes

Countries

  • United States

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 NCT05106192 on ClinicalTrials.gov