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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/8/2018
Start Date:December 2015
Contact:Christopher Pullion, DO
Email:cpullion@soligenix.com
Phone:609-538-8200

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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

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


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.
We found this trial at
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Little Rock, Arkansas 72202
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Annandale, Virginia 22003
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Baltimore, Maryland 20742
(301) 405-1000
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, Illinois 60612
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Clearwater, Florida 33757
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Duarte, California 91010
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Fairport, New York 14450
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Greenville, South Carolina 29605
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Houston, Texas 77030
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Indianapolis, Indiana 46256
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Lafayette, Louisiana 70508
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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2020 West 64th Street
Miami, Florida 33015
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3400 Southwest 107th Avenue
Miami, Florida 33165
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
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New Orleans, Louisiana 70112
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630 W 168th St
New York, New York
212-305-2862
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Norfolk, Virginia 23507
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Palo Alto, California 94304
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833 Chestnut Street
Philadelphia, Pennsylvania 19107
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550 East Van Buren Street
Phoenix, Arizona 85004
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Saint Louis, Missouri 63110
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San Diego, California 92123
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Seattle, Washington 98109
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Stony Brook, New York 11794
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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