PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.

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

Details

• Lead Sponsor: Soligenix
• Treatments: Hypericin

Criteria

Inclusion Criteria:

• A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA

• CTCL lesions covering ≥ 10% of their body surface area

Exclusion Criteria:

• History of allergy or hypersensitivity to any of the components of HyBryte

• 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 (SLE), Sjogren's syndrome, etc.)

• Subjects whose condition is spontaneously improving

• Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index lesions for CTCL within 2 weeks of enrollment

• Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (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

• Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks