Clinical trial · Interventional
IL-35: A Key Immunosuppressive Driver in Mycosis Fungoides Modulated by Phototherapy
Estimation of Serum and Tissue Level of Interleukin-35 (IL-35) in Mycosis Fungoides Before and After Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Mycosis fungoides is the most common type of skin lymphoma. It develops when certain white blood cells (T cells) grow abnormally in the skin, causing red, scaly, or itchy patches. The disease is often treated with phototherapy, a light-based treatment that can control symptoms in early stages. This study looked at a protein called interleukin-35 (IL-35), which normally helps regulate the immune system but can also suppress the body's ability to fight cancer. The investigators aimed to determine if IL-35 levels are higher in patients with mycosis fungoides and whether phototherapy can change those levels. The study enrolled 16 patients with mycosis fungoides and compared them to 16 healthy people. Blood samples and small skin biopsies were taken before and after phototherapy. The study found that IL-35 levels were significantly higher in patients than in healthy people. After phototherapy, IL-35 levels dropped back to normal. These results suggest that phototherapy not only treats skin lesions directly but also helps restore immune balance by lowering IL-35. IL-35 may become a useful marker to monitor disease activity and treatment response in patients with mycosis fungoides.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phototherapy (PUVA or NB-UVB) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phototherapy Arm (Mycosis Fungoides Patients)
- description
- Phototherapy Arm (Mycosis Fungoides Patients)
- interventionNames
- Radiation: Phototherapy (PUVA or NB-UVB)
Primary outcomes (1)
- measure
- Change in serum and tissue interleukin-35 (IL-35) levels in mycosis fungoides patients before and after phototherapy
- timeFrame
- Baseline and after up to 36 phototherapy sessions (approximately 3 months)
- description
- Serum IL-35 concentration (ng/ml) measured by ELISA and tissue IL-35 concentration (ng/g) measured from skin biopsy homogenates. Samples collected at baseline and after completion of phototherapy (PUVA or NB-UVB). The primary endpoint is the difference in IL-35 levels pre- and post-treatment.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with mycosis fungoides; newly diagnosed or recurrent after cessation of treatment * Both genders * Age group ≥ 18 years old Exclusion Criteria: * Patients with any contraindication to phototherapy (e.g., any other skin cancers or photosensitivity); or to psoralen (e.g., liver disease). * Subjects with history of solid or hematological malignancy as leukemia. * Patients with autoimmune disease as SLE. * Patients who received treatment for the past one month. * Pregnant and lactating females
References
Publications (0)
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