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

Trial ID or NCT#

NCT02448381

Status

not recruiting iconNOT RECRUITING

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 Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Contact us to find out if this trial is right for you.

Contact

Sophia Fong
650-498-8604

View on ClinicalTrials.gov