Non Hodgkin Lymphoma Clinical Trial
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
> 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
Exclusion Criteria:
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
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There is 1 Location for this study
Cleveland Ohio, 44106, United States
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