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FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
Not Recruiting
Trial ID: NCT02448381
Purpose
To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with
patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Official Title
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
Eligibility
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.
Intervention(s):
drug: SGX301 (synthetic hypericin)
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sophia Fong
650-498-8604