Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

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.