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Corticosteroid

Needle-free Triamcinolone Acetonide Injection for Cutaneous Lymphoma

N/A

Waitlist Available

Led By Kevin Cooper, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The presence of plaque-type primary cutaneous lymphoma lesions with at least two plaques that are at least two cm² in areas of the trunk, buttocks, or extremities that are either symmetrically located on contralateral body site or within the same body site but separated by ≥ 1 cm. Both plaques must be similar in size as much as possible

> 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 1 month, 2 months, and 3 months

Awards & highlights

Study Summary

This trial will compare the MedJet needle-free drug-delivery system to standard care for treating skin lymphomas.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Triamcinolone may cause skin irritation, increased infection risk at injection sites, changes in skin color or texture. Bexarotene could lead to itching or redness where applied. Nitrogen Mustard might result in local blistering and long-term skin discoloration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 1 month, 2 months, and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 1 month, 2 months, and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 1 month, 2 months, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain measurement between the Med-Jet and standard of care treatment.

Secondary outcome measures

CAILS assessment of clinical efficacy

Participants Preference

Quality of life due to skin conditions

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cutaneous T-cell lymphomas (CTCL) ParticipantsExperimental Treatment4 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) ParticipantsExperimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Triamcinolone Acetonide

2018

Completed Phase 4

~3730

Nitrogen Mustard

2006

Completed Phase 2

~90

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,888 Total Patients Enrolled

Kevin Cooper, MDPrincipal InvestigatorCase Comprehensive Cancer Center

5 Previous Clinical Trials

186 Total Patients Enrolled

Media Library

Triamcinolone Acetonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05106192 — N/A

Cutaneous T-Cell Lymphoma Research Study Groups: Cutaneous B-cell lymphomas (CBCL) Participants, Cutaneous T-cell lymphomas (CTCL) Participants

Cutaneous T-Cell Lymphoma Clinical Trial 2023: Triamcinolone Acetonide Highlights & Side Effects. Trial Name: NCT05106192 — N/A

Triamcinolone Acetonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05106192 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this research project?

"Unfortunately, the recruitment phase for this clinical trial is currently closed. It was initially posted on December 1st 2022 and most recently updated August 15th 2022. If you are looking to join a different medical study, there are 1800 studies actively seeking participants with lymphoma and 73 trials in need of Triamcinolone Acetonide enrollees."

Answered by AI

Are there any openings for new participants in this experiment?

"The recruitment phase for this trial has ended. Initially posted on December 1st 2022, it was most recently updated on August 15th 2022. Should you wish to pursue other options, there are 1800 clinical trials actively recruiting patients with lymphoma and a further 73 trials actively seeking individuals to test Triamcinolone Acetonide."

Answered by AI

To what extent can Triamcinolone Acetonide be employed to improve medical conditions?

"Triamcinolone Acetonide is the accepted method of treatment for ulcerative colitis, and it also has been used to manage a variety hand, brain, or dermatologic pathologies."

Answered by AI

Has there been further research into the efficacy of Triamcinolone Acetonide?

"Currently, there are 73 different studies exploring the efficacy of Triamcinolone Acetonide. While most of these trials originate from Dallas, Texas, there are 961 clinical sites involved in this research endeavour. Of those investigations 11 have graduated to Phase 3 status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05106192.

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