Actively Recruiting
A Confirmatory Phase 3 Randomized, Double-Blind Study of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for Cutaneous T-Cell Lymphoma
Led by Soligenix · Updated on 2026-04-03
80
Participants Needed
17
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of HyBryte, a topical photosensitizing gel containing 0.25% hypericin, for treating patients with patch or plaque phase cutaneous T-cell lymphoma (CTCL), including mycosis fungoides. The study is a Phase 3, randomized, double-blind, placebo-controlled trial designed to compare the treatment response of HyBryte plus visible light to placebo plus visible light over an 18-week period. Participants will apply either HyBryte gel or placebo gel twice weekly for 18 weeks to all readily available skin lesions. Treated areas are covered with opaque material before receiving visible light exposure about 21 hours later. The study includes the identification and documentation of 3 to 5 index lesions for detailed assessment. After treatment, participants will be followed every 4 weeks for 12 weeks to monitor outcomes. During the trial, researchers will evaluate lesion severity using the modified Composite Assessment of Index Lesion Severity (mCAILS) score, tracking treatment response at 18 weeks. Safety and efficacy will be assessed alongside secondary measures such as patch and plaque lesion response rates. Participants will undergo regular assessments throughout treatment and follow-up, with close monitoring for any adverse effects or changes in disease status.
CONDITIONS
Brief Title
Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- History of sun hypersensitivity or photosensitive skin disorders such as porphyria, lupus, Sj�f6gren's syndrome, xeroderma pigmentosum, or polymorphous light eruptions.
- Radiation therapy within 30 days prior to enrollment.
- Allergy or hypersensitivity to any components of HyBryte.
- Screening ECG showing QT interval greater than 470 ms.
- Women of childbearing potential and males with partners of childbearing potential not willing to use effective contraception.
- Use of topical steroids or other topical treatments on treated lesions within 2 weeks of enrollment.
- Use of systemic steroids, psoralen UVA, narrow band UVB, carmustine, or other systemic CTCL therapies within 4 weeks of enrollment.
- Electron beam irradiation within 3 months prior to enrollment.
- History of significant systemic immunosuppression.
- Use of investigational drugs or drugs of abuse within 30 days prior to the study.
- Patients whose condition is spontaneously improving.
- Tumor stage or erythrodermic CTCL (stages IIB-IV).
- Extensive skin disease covering more than 30% body surface area if systemic treatment is indicated.
- Any condition that may interfere with study participation as judged by the Principal Investigator.
- Prior participation in this study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 weeks
Participants apply HyBryte gel or placebo gel twice weekly for 18 weeks. Treated lesions are covered with opaque material, followed about 21 hours later by visible light exposure.
Twice weekly visits for gel application and light exposure
Duration - 12 weeks
Participants are followed every 4 weeks for 12 weeks after their last light session to monitor treatment response and safety.
Visits every 4 weeks for up to 3 visits
Trial Site Locations
Total: 17 locations
1
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
Completed
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
Therapeutics Clinical Research
San Diego, California, United States, 92123
Completed
4
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
5
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, United States, 46256
Actively Recruiting
7
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Rochester Skin Lymphoma Medical Group
Fairport, New York, United States, 14450
Actively Recruiting
9
Columbia University Medical Center
New York, New York, United States, 10032
Completed
10
Accellacare (PMG)
Wilmington, North Carolina, United States, 28411
Completed
11
Penn State Health Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
12
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
14
Vanderbilt University
Nashville, Tennessee, United States, 37212
Completed
15
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
16
Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660
Actively Recruiting
17
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
J
Jennifer Bonfrisco
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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