Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

NCT ID: NCT05872854

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2025-12-15

Brief Summary

The goal of this clinical trial is to assess the benefit of continuous treatment with synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks). Funding Source: FDA OOPD.

Detailed Description

This is an open label trial in which patients will have their mycosis fungoides (MF) lesions treated twice a week with HyBryte ointment that is followed, 24 hours later (±6 hours), by activation of the drug with visible light treatment. Patients will treat all of their MF lesions (where accessible to light therapy), but 3 to 5 lesions will be identified and followed as "Index Lesions" that will be evaluated using the Composite Assessment of Index Lesion Severity (CAILS) score every 6 weeks for the up to 54 weeks of therapy. Patients will be treated until resolution, dropout for adverse events, or plateau of therapeutic response occurs. Changes in the skin scoring mechanisms such as the CAILs and mSWAT will be tabulated for each patient and assessed across all patients enrolled in the trial to determine the response profile of HyBryte and visible light treatment.

Conditions

Cutaneous T Cell Lymphoma; Mycosis Fungoides

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HyBryte (0.25 % Hypericin) with Visible Light

HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 24 (±6) hours later starting at 5 J/cm\^2. Drug application/light sessions will be done twice a week (at least 2 calendar days apart) for up to 54 weeks.

Group Type: EXPERIMENTAL

Hypericin

Intervention Type: DRUG

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment

Visible Light

Intervention Type: OTHER

After application of HyBryte (0.25% hypericin ointment), participants will be placed in a light booth containing fluorescent light bulbs to activate the HyBryte.

Interventions

Hypericin

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment

Intervention Type: DRUG

Visible Light

After application of HyBryte (0.25% hypericin ointment), participants will be placed in a light booth containing fluorescent light bulbs to activate the HyBryte.

Intervention Type: OTHER

Other Intervention Names

HyBryte; SGX301; Fluorescent light

Eligibility Criteria

Inclusion Criteria

• Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage 1A, Stage 1B, or Stage 2A.

(Stage 1 is divided into stages 1A and 1B as follows: Stage 1A: Patches, papules, and/or plaques cover less than 10% of the skin surface. Stage 1B: Patches, papules, and/or plaques cover 10% or more of the skin surface. Stage 2A: Patches, papules, and/or plaques cover any amount of skin surface. Lymph nodes are abnormal, but they are not cancerous.)

• Subjects willing to follow the clinical protocol and voluntarily give their written informed consent
• Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 21 days prior to treatment initiation and agree to use a medically accepted method of birth control such as oral contraceptives (birth control pill), Barrier method (condom plus spermicide or diaphragm plus spermicide) or abstaining from intercourse while on study

Exclusion Criteria

• History of allergy or hypersensitivity to any of the components of SGX301
• Pregnancy or mothers who are breast-feeding
• Males and females not willing to use effective contraception
• Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus, Sjogren's, etc.).
• Subjects whose condition is spontaneously improving.
• Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on lesions for CTCL within 2 weeks of enrollment
• Subjects receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
• Subjects who have received electron beam irradiation within 3 months of enrollment
• Subjects with a history of significant systemic immunosuppression
• Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
• Subject with any condition that, in the judgment of the PI, is likely to interfere with participation in the study
• Subjects receiving drugs known to cause photosensitization within 2 weeks of starting SGX301 therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soligenix

INDUSTRY

Sponsor Role: collaborator

Ellen Kim, MD

OTHER

Sponsor Role: lead

Responsible Party

Ellen Kim, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

RW-HPN-MF-01

Identifier Type: OTHER

Identifier Source: secondary_id

851617

Identifier Type: OTHER

Identifier Source: secondary_id

05622 (UPCC)

Identifier Type: -

Identifier Source: org_study_id