Last updated on December 2017

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Mycosis Fungoides | Cutaneous T-Cell Lymphoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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