confirmatory study of topical hybryte™ vs. placebo for the treatment of ctcl

Conditions: CTCL/ Mycosis Fungoides; CTCL; Mycosis Fungoides; Cutaneous T Cell Lymphoma

Summary: 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 exposure to the visible light source will be treated and 3 to 5 index lesions in each patient will be prospectively identified and documented for modified composite assessment of index lesion severity (mcails) evaluation. participants will be followed every 4 weeks for a total of 12 weeks following their last light session.

Eligibility criteria:
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 pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling. * history of allergy or hypersensitivity to any of the components of hybryte. * a screening ecg with a qt interval \>470 ms (corrected for heart rate using the fridericia's formula). * all women of childbearing potential (wocbp) and males with female partners who are wocbp not willing to use effective contraception. * 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 taking other investigational drugs or drugs of abuse within 30 days of entry into this study. * patients whose condition is spontaneously improving. * 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. * patient has any condition that, in the judgment of the pi, is likely to interfere with participation in the study. * prior participation in the current study.