Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

• Status: Not yet recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ellen Kim, MD
• Collaborators: Office of Orphan Products Development; Soligenix
• Treatments: Hypericin

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.