Mycosis FungoidesNCT07235813
IL-35: A Key Immunosuppressive Driver in Mycosis Fungoides Modulated by Phototherapy
A study testing Phototherapy (PUVA or NB-UVB) in people with Mycosis Fungoides, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides
- What is being tested?
- Phototherapy (PUVA or NB-UVB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with mycosis fungoides; newly diagnosed or recurrent after cessation of treatment
- Both genders
- Age group ≥ 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Serum and Tissue Level of Interleukin-35 (IL-35) in Mycosis Fungoides Before and After Treatment
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.
Read more
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.
Read the detailed description
Mycosis fungoides (MF) is the most common primary cutaneous T-cell lymphoma and is characterized by progressive immune dysregulation. Early disease often shows a T helper 1 (Th1) profile, while advanced stages shift toward an immunosuppressive T helper 2 (Th2) environment that promotes tumor persistence. Interleukin-35 (IL-35), a recently described member of the IL-12 cytokine family, has emerged as a potent immunosuppressive cytokine. It contributes to tumor growth by suppressing anti-tumor T-cell responses, expanding regulatory T cells, and fostering angiogenesis. Elevated IL-35 levels have been reported in several malignancies, including MF, but its behavior under therapeutic intervention has not been well defined.
Phototherapy, including psoralen plus ultraviolet A (PUVA) and narrowband ultraviolet B (NB-UVB), remains a cornerstone treatment for early-stage MF. Beyond its direct cytotoxic effects on malignant T cells, phototherapy exerts broad immunomodulatory actions on the cutaneous cytokine milieu. Prior studies have shown normalization of cytokines such as IL-15 following phototherapy, suggesting that its benefits extend beyond lesion clearance to restoration of immune balance.
This prospective interventional cohort study was designed to evaluate whether IL-35 levels in serum and skin tissue are altered by phototherapy in MF patients. Sixteen patients with histologically confirmed MF and sixteen matched healthy controls were enrolled. IL-35 was measured at baseline in both groups and again after phototherapy in patients. The study demonstrated that IL-35 levels were significantly elevated in MF patients compared to controls, and that both serum and tissue IL-35 declined after phototherapy, normalizing to control levels. These findings suggest that phototherapy may correct the immunosuppressive environment characteristic of MF, and that IL-35 could serve as a biomarker for disease activity and treatment response.
- Conditions
- Mycosis Fungoides
- Being tested
- Phototherapy (PUVA or NB-UVB)
- Medical subject headings
- Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy Arm (Mycosis Fungoides Patients) | Experimental | Phototherapy Arm (Mycosis Fungoides Patients) Receives: Radiation: Phototherapy (PUVA or NB-UVB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after up to 36 phototherapy sessions (approximately 3 months)
Secondary outcomes (6)
Correlation between IL-35 levels and patient age
Assessment of the relationship between IL-35 levels (serum and tissue, baseline and post-treatment) and patient age in mycosis fungoides patients using Pearson or Spearman correlation analysis.
Measured: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between IL-35 levels and disease extent
Assessment of the relationship between IL-35 levels (serum and tissue, baseline and post-treatment) and disease extent (measured by body surface area percentage) in mycosis fungoides patients using Pearson or Spearman correlation analysis.
Measured: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between serum and tissue IL-35 levels
Assessment of the relationship between serum IL-35 concentration (ng/ml) and tissue IL-35 concentration (ng/g) at baseline and following phototherapy in mycosis fungoides patients using Pearson or Spearman correlation analysis.
Measured: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between IL-35 levels and lactate dehydrogenase (LDH)
Assessment of the relationship between IL-35 levels (serum and tissue, baseline and post-treatment) and serum lactate dehydrogenase levels in mycosis fungoides patients using Pearson or Spearman correlation analysis.
Measured: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between IL-35 levels and beta-2 microglobulin
Assessment of the relationship between IL-35 levels (serum and tissue, baseline and post-treatment) and serum beta-2 microglobulin levels in mycosis fungoides patients using Pearson or Spearman correlation analysis.
Measured: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between IL-35 levels and disease duration
Assessment of the relationship between IL-35 levels (serum and tissue, baseline and post-treatment) and disease duration in mycosis fungoides patients using Pearson or Spearman correlation analysis.
Measured: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jan 2025
- Primary completion6 Jul 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ahmed abdelgayed ibrahim, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235813
- Sponsor's protocol ID
- N-384-2024
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Serum and Tissue Level of Interleukin-35 (IL-35) in Mycosis Fungoides Before and After Treatment
- ClinicalTrials.gov ID
- NCT07235813
- Acronym / sponsor ID
- N-384-2024
- Conditions
- Mycosis Fungoides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 6 Jul 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mycosis fungoides (MF) is the most common primary cutaneous T-cell lymphoma and is characterized by progressive immune dysregulation. Early disease often shows a T helper 1 (Th1) profile, while advanced stages shift toward an immunosuppressive T helper 2 (Th2) environment that promotes tumor persistence. Interleukin-35 (IL-35), a recently described member of the IL-12 cytokine family, has emerged as a potent immunosuppressive cytokine. It contributes to tumor growth by suppressing anti-tumor T-cell responses, expanding regulatory T cells, and fostering angiogenesis. Elevated IL-35 levels have been reported in several malignancies, including MF, but its behavior under therapeutic intervention has not been well defined.
Phototherapy, including psoralen plus ultraviolet A (PUVA) and narrowband ultraviolet B (NB-UVB), remains a cornerstone treatment for early-stage MF. Beyond its direct cytotoxic effects on malignant T cells, phototherapy exerts broad immunomodulatory actions on the cutaneous cytokine milieu. Prior studies have shown normalization of cytokines such as IL-15 following phototherapy, suggesting that its benefits extend beyond lesion clearance to restoration of immune balance.
This prospective interventional cohort study was designed to evaluate whether IL-35 levels in serum and skin tissue are altered by phototherapy in MF patients. Sixteen patients with histologically confirmed MF and sixteen matched healthy controls were enrolled. IL-35 was measured at baseline in both groups and again after phototherapy in patients. The study demonstrated that IL-35 levels were significantly elevated in MF patients compared to controls, and that both serum and tissue IL-35 declined after phototherapy, normalizing to control levels. These findings suggest that phototherapy may correct the immunosuppressive environment characteristic of MF, and that IL-35 could serve as a biomarker for disease activity and treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phototherapy Arm (Mycosis Fungoides Patients) | Experimental | Radiation: Phototherapy (PUVA or NB-UVB)Phototherapy Arm (Mycosis Fungoides Patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with mycosis fungoides; newly diagnosed or recurrent after cessation of treatment
- Both genders
- Age group ≥ 18 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Phototherapy Arm (Mycosis Fungoides Patients) |
Primary outcome
Change in serum and tissue interleukin-35 (IL-35) levels in mycosis fungoides patients before and after phototherapy
Time frame: Baseline and after up to 36 phototherapy sessions (approximately 3 months)
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.
6 secondary outcomes
Correlation between IL-35 levels and patient age
Time frame: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between IL-35 levels and disease extent
Time frame: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between serum and tissue IL-35 levels
Time frame: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between IL-35 levels and lactate dehydrogenase (LDH)
Time frame: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between IL-35 levels and beta-2 microglobulin
Time frame: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Correlation between IL-35 levels and disease duration
Time frame: Baseline and after completion of phototherapy (up to 36 sessions, approximately 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy (PUVA or NB-UVB) in people with Mycosis Fungoides, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum and tissue interleukin-35 (IL-35) levels in mycosis fungoides patients before and after phototherapy (time frame: Baseline and after up to 36 phototherapy sessions (approximately 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.