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Topical JAK-Inhibition of Early-Stage CTCL
Sponsor: Aarhus University Hospital
Summary
This study tests whether a cream named delgocitinib (Anzupgo), applied twice daily to the skin, is safe and well tolerated in people with early-stage cutaneous T-cell lymphoma (a rare type of skin cancer called mycosis fungoides). The cream works by blocking proteins called JAK enzymes, which are involved in inflammation and cancer cell growth in the skin. Delgocitinib cream is already approved for treating chronic hand eczema, but it has not yet been studied in people with cutaneous T-cell lymphoma. In this study, up to 15 participants with stable, early-stage disease will apply the cream to their affected skin for 16 weeks. Researchers will closely monitor for side effects and also look at whether the cream improves skin symptoms, such as itching and the appearance of the skin. Participants will be followed for 4 additional weeks after treatment ends. This is an early, exploratory study (a "proof-of-concept" trial) designed mainly to check safety, not to prove that the treatment works. The findings will help researchers decide whether to test this cream in larger studies in the future.
Official title: An Investigator-Initiated, Descriptive, Proof-of-Concept, Open-Label Pilot Study Focusing on Topical JAK Inhibition as a Novel Treatment of Cutaneous T-Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-09
Completion Date
2030-06
Last Updated
2026-08-26
Healthy Volunteers
No
Interventions
delgocitinib
Delgocitinib is a pan-Janus kinase (JAK1, JAK2, JAK3, TYK2) inhibitor formulated as a 20 mg/g topical cream, marketed as Anzupgo and approved by the European Medicines Agency for chronic hand eczema. In this study, delgocitinib cream is applied topically to affected skin areas twice daily for 16 weeks, off-label, for the treatment of early-stage cutaneous T-cell lymphoma.