A Confirmatory Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

The purpose of this study is to evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

For more information, visit: https://clinicaltrials.gov/study/NCT06470451

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031

• Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.
• Patients with a minimum of three (3) evaluable, discrete lesions.

• History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling.
• History of allergy or hypersensitivity to any of the components of HyBryte.
• Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.
• Patients 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 4 weeks of enrollment.
• Patients who have received electron beam irradiation within 3 months of enrollment.
• Patients with a history of significant systemic immunosuppression.
• Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).
• Patients with extensive skin disease (>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.