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

NCT07235813 | Completed

• 1 other identifier: N-384-2024
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in serum and tissue interleukin-35 (IL-35) levels in mycosis fungoides patients before and after phototherapy

  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.

  Baseline and after up to 36 phototherapy sessions (approximately 3 months)

Secondary Outcomes (6)

• Correlation between IL-35 levels and patient age

  Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)

• Correlation between IL-35 levels and disease extent

  Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)

• Correlation between serum and tissue IL-35 levels

  Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)

• Correlation between IL-35 levels and lactate dehydrogenase (LDH)

  Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)

• Correlation between IL-35 levels and beta-2 microglobulin

  Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)

Study Arms (1)

Phototherapy Arm (Mycosis Fungoides Patients)

EXPERIMENTAL

Phototherapy Arm (Mycosis Fungoides Patients)

Radiation: Phototherapy (PUVA or NB-UVB)

Interventions

Phototherapy (PUVA or NB-UVB) RADIATION

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.

Phototherapy Arm (Mycosis Fungoides Patients)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with mycosis fungoides; newly diagnosed or recurrent after cessation of treatment
• Both genders
• Age group ≥ 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Aini Hospital

Cairo, English (English), 11511, Egypt

Location

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology, Cairo University

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 1, 2025
• Primary Completion: July 6, 2025
• Study Completion: October 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)