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)
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.
• Patients with a minimum of three (3) evaluable, discrete lesions.
• Patients willing to follow the clinical protocol and voluntarily give their written informed consent.
• Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.
Locations
United States
Arizona
Medical Dermatology Specialists
RECRUITING
Phoenix
Mayo Clinic
RECRUITING
Scottsdale
California
Therapeutics Clinical Research
RECRUITING
San Diego
Florida
University of South Florida
RECRUITING
Tampa
Illinois
Northwestern University
RECRUITING
Chicago
Indiana
Dawes Fretzin Dermatology Group
RECRUITING
Indianapolis
Missouri
Washington University
RECRUITING
St Louis
North Carolina
Accellacare (PMG)
RECRUITING
Wilmington
New York
Rochester Skin Lymphoma Medical Group
RECRUITING
Fairport
Columbia University Medical Center
RECRUITING
New York
Pennsylvania
Penn State Health Hershey Medical Center
RECRUITING
Hershey
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Tennessee
Vanderbilt University
RECRUITING
Nashville
Texas
MD Anderson
RECRUITING
Houston
Austin Institute for Clinical Research
RECRUITING
Pflugerville
Virginia
Inova Schar Cancer Institute
RECRUITING
Fairfax
Contact Information
Primary
Jennifer Bonfrisco
jbonfrisco@soligenix.com
609-538-8200
Time Frame
Start Date: 2025-01-07
Estimated Completion Date: 2026-10
Participants
Target number of participants: 80
Treatments
Experimental: HyBryte (0.25% Hypericin)
HyBryte gel is applied twice weekly for 18 weeks.
Placebo_comparator: Placebo
Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks.
Related Therapeutic Areas
Sponsors
Leads: Soligenix