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Spots Global Cancer Trial Database for Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.

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Trial Identification

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

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

Study ID: NCT05106192

Study Description

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.

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Contact Details

Name: Kevin Cooper, MD

Affiliation: Case Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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