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

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Treatments: Bexarotene; Mechlorethamine; Nitrogen Mustard Compounds; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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