Soligenix
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
The primary objective of this Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patch/plaque phase CTCL compared to patients receiving placebo and visible light.The study will evaluate the efficacy and safety of HyBryte (0.25% hypericin) gel or placebo gel applied twice weekly for 18 weeks. Treated lesions will be covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. All of the participant's lesions that are readily available for exposu…
Inclusion Criteria: * 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. * Patients willing to follow the clinical protocol and voluntarily give their written informed consent. * Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation. Exclusion Criteria: * History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma…
HyBryte gel (0.25% hypericin) is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.
Placebo gel is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.