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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cutaneous T-Cell Lymphoma

In brief

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

Key facts

Study ID

NCT02448381

Run by

Soligenix

People needed

169

Starts

2015-12-01

Expected to finish

2020-11-01

Last updated by the study team

2022-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• University of Arizona — Phoenix, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• University of Arkansas — Little Rock, Arkansas, United States
• Stanford University — Palo Alto, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Olympian Clinical Research — Clearwater, Florida, United States
• Leon Medical Research — Miami, Florida, United States
• Medical Professional Clinical Research — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University — Chicago, Illinois, United States
• Dawes Fretzin Dermatology Group — Indianapolis, Indiana, United States
• Tulane University — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Rochester Skin Lymphoma Medical Group — Fairport, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Stony Brook Medicine — Stony Brook, New York, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Jefferson Dermatology — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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