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

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