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NCT05106192 | NOT YET RECRUITING | Mycosis Fungoides of Skin (Diagnosis)

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

Case Comprehensive Cancer Center

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.

Condition or disease

Mycosis Fungoides of Skin (Diagnosis)

Cutaneous T-cell Lymphoma

Non Hodgkin Lymphoma

Lymphomatoid Papulosis

Lymphoma, Large-Cell, Anaplastic

Lymphoma, Follicular

Intervention/treatment

Med-Jet Injector

Triamcinolone Acetonide

Bexarotene 1% Top Gel

Nitrogen Mustard

Conventional syringe

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 22 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2025-12-01
Estimated Study Completion Date : 2026-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.

Location Details

NCT05106192

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How to Participate

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Locations

Not yet recruiting

United States, Ohio

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44106