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IL-35: A Key Immunosuppressive Driver in Mycosis Fungoides Modulated by Phototherapy

NCT07235813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-11-19

No results posted yet for this study

Summary

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

  • Mycosis Fungoides

Interventions

RADIATION

Phototherapy (PUVA or NB-UVB)

Patients with mycosis fungoides will receive phototherapy three times per week. Most will undergo psoralen plus UVA (PUVA) with dose escalation based on skin phototype and tolerance. A minority may receive narrowband UVB (NB-UVB) following standard protocols. Treatment continues until lesion resolution or a maximum of 36 sessions. Blood and skin samples are collected before and after treatment to measure IL-35 levels.

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-07-06
Completion
2025-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07235813 on ClinicalTrials.gov