Study Stopped
Study closed prior to enrollment of first participant
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedJune 12, 2025
June 1, 2025
3.2 years
October 12, 2021
June 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pain measurement between the Med-Jet and standard of care treatment.
The pain of injections with Medjet vs conventional topical therapies of bexarotene or nitrogen mustard will be measured using a visual standard analog pain scale 0 (no distress) to 10 (unbearable distress) immediately after each injection.
1.5 Hour after the treatment
Secondary Outcomes (4)
Participants Preference
3 Months
Tolerability of Pruritus
At Baseline, 1 month, 2 months, and 3 months
Quality of life due to skin conditions
3 Months
CAILS assessment of clinical efficacy
At Baseline, 1 month, 2 months, and 3 months
Study Arms (2)
Cutaneous T-cell lymphomas (CTCL) Participants
EXPERIMENTALThe 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.
Cutaneous B-cell lymphomas (CBCL) Participants
EXPERIMENTALThe 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.
Interventions
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
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).
Bexarotene can be applied up to four times daily according to patient tolerance directly to lesions. The gel is 1% bexarotene concentration.
Nitrogen mustard is applied once daily as patient tolerates. It is sold in a concentration of 0.016% gel.
A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.
Eligibility Criteria
You may qualify if:
- \> 18 years of age
- Diagnosed with primary cutaneous lymphoma defined by either:
- A board-certified dermatologist, OR
- Dermatology Nurse Practitioner, OR
- Skin punch biopsy
- 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
- Able to give informed consent under IRB approval procedures
You may not qualify if:
- Known allergy or hypersensitivity to triamcinolone acetonide
- Known allergy to topical bexarotene or topical nitrogen mustard
- Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
- Inability to provide informed consent
- Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome
- Use of topical corticosteroids to target lesions within 1 week prior to baseline visit
- Use of radiation therapy to target lesions within 1 week prior to baseline visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Cooper, MD
Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2021
First Posted
November 3, 2021
Study Start
April 1, 2022
Primary Completion
June 1, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- It will be immediately available upon request at completion of study.