Needle-free Triamcinolone Acetonide Injection for Cutaneous Lymphoma

Overseen By Amy Johnson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Case Comprehensive Cancer Center

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kevin Cooper, MD

Principal Investigator

Case Comprehensive Cancer Center

Eligibility Criteria

Adults diagnosed with primary cutaneous lymphoma by a dermatologist, nurse practitioner, or biopsy can join. They must have similar-sized skin plaques suitable for treatment and be able to consent. Excluded are those allergic to trial drugs, pregnant or breastfeeding women, patients with certain severe lymphomas, or recent users of corticosteroids/radiation on lesions.

Inclusion Criteria

I have skin lymphoma with two large, similar-sized patches on my body.

I am older than 18 years.

Able to give informed consent under IRB approval procedures

Exclusion Criteria

I have been diagnosed with erythrodermic mycosis fungoides or Sezary syndrome.

Known allergy to topical bexarotene or topical nitrogen mustard

Inability to provide informed consent

Treatment Details

Interventions

• Med-Jet Injector (Procedure)
• Triamcinolone Acetonide (Corticosteroid)

Trial Overview The study is testing the pain levels when using MedJet needle-free system versus conventional syringes for delivering Triamcinolone Acetonide into skin lymphoma plaques. It also looks at how well these methods work compared to standard treatments like Bexarotene gel and Nitrogen Mustard.

Participant Groups

Group I: Cutaneous T-cell lymphomas (CTCL) Participants Experimental Treatment 4 Interventions

The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-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.

Group II: Cutaneous B-cell lymphomas (CBCL) Participants Experimental Treatment 3 Interventions

The first plaque will be treated using standard of care 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.

Triamcinolone Acetonide is already approved in Canada, Japan for the following indications:

Approved in Canada as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in Japan as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+