FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Inclusion Criteria:

• Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA.
• Subjects must have a minimum of three (3) evaluable, discrete lesions.
• Subjects must be willing to refrain from sunbathing for the duration of the study.

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.
• Pregnancy or mothers who are breast feeding.
• Males and females not willing to use effective contraception.
• Unhealed sunburn.
• Subjects receiving topical steroids or other topical treatments for CTCL within 2 weeks.
• Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment.
• Subjects with significant history of systemic immunosuppression due to drugs or infection with HIV or HTLV 1.
• Subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.