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), StageIA, 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 writteninformed consent.

• Female patients not pregnant or nursing and willing to undergo a pregnancy testwithin 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 theFridericia's formula).

• All women of childbearing potential (WOCBP) and males with female partners who areWOCBP not willing to use effective contraception.

• Patients receiving topical steroids or other topical treatments (eg, nitrogenmustard) on treated lesions for CTCL within 2 weeks of enrollment.

• Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrowband UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies forCTCL 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 ofentry 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 thejudgement of the Principal Investigator, candidates for systemic treatment.

• Patient has any condition that, in the judgment of the PI, is likely to interferewith participation in the study.

• Prior participation in the current study.