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

• Status: Active, not recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soligenix
• Treatments: Hypericin

Criteria

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.