FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of 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.