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

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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.

Conditions:

Mycosis Fungoides of Skin (Diagnosis) Cutaneous T-cell Lymphoma Non Hodgkin Lymphoma Lymphomatoid Papulosis Lymphoma, Large-Cell, Anaplastic Lymphoma, Follicular

Study Start (Actual) 2024-06-01

Primary Completion (Estimated) 2024-12-01

Study Completion (Estimated) 2025-02-01

Enrollment (Estimated) 22

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 Cleveland, Ohio, United States

Eligibility Criteria

Description

Inclusion Criteria:

1. \> 18 years of age
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:

1. Known allergy or hypersensitivity to triamcinolone acetonide
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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2021-10-12
First Submitted that Met QC Criteria2021-11-02
First Posted2021-11-03

Study Record Updates

Last Update Submitted that Met QC Criteria2023-12-18
Last Update Posted2023-12-19
Last Verified2023-12