Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
NCT ID: NCT05106192
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-04-01
2026-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Cutaneous T-cell lymphomas (CTCL) Participants
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.
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
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).
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.
Nitrogen Mustard
Nitrogen mustard is applied once daily as patient tolerates. It is sold in a concentration of 0.016% gel.
Cutaneous B-cell lymphomas (CBCL) Participants
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.
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
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).
Conventional syringe
A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.
Interventions
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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
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).
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.
Nitrogen Mustard
Nitrogen mustard is applied once daily as patient tolerates. It is sold in a concentration of 0.016% gel.
Conventional syringe
A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with primary cutaneous lymphoma defined by either:
* A board-certified dermatologist, OR
* Dermatology Nurse Practitioner, OR
* Skin punch biopsy
3. 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
4. Able to give informed consent under IRB approval procedures
Exclusion Criteria
2. Known allergy to topical bexarotene or topical nitrogen mustard
3. Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
4. Inability to provide informed consent
5. Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome
6. Use of topical corticosteroids to target lesions within 1 week prior to baseline visit
7. Use of radiation therapy to target lesions within 1 week prior to baseline visit
18 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kevin Cooper, MD
Role: PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center
Locations
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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE4621
Identifier Type: -
Identifier Source: org_study_id
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