NCT05106192

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will undergo treatments on two morphologically and anatomically matched target lesions, preferably on opposing sides of the body. The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) or intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas). The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded. In order to account for 20% dropout, 11 patients per group (a needle free and a traditional treatment group in CBCL patients and the same two groups in CTCL patients) will be recruited.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2021-11-03
• Last updated: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study