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Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
Sponsor: Soligenix
Summary
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Official title: A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-01-07
Completion Date
2026-10
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
Hypericin
HyBryte gel (0.25% hypericin) is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.
Placebo
Placebo gel is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.
Locations (17)
Medical Dermatology Specialists
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Therapeutics Clinical Research
San Diego, California, United States
University of South Florida
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, United States
Washington University
St Louis, Missouri, United States
Rochester Skin Lymphoma Medical Group
Fairport, New York, United States
Columbia University Medical Center
New York, New York, United States
Accellacare (PMG)
Wilmington, North Carolina, United States
Penn State Health Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States