Actively Recruiting
Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
Led by Soligenix · Updated on 2026-04-03
80
Participants Needed
17
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
CONDITIONS
Official 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 and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sj�f6gren's syndrome, xeroderma pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling.
- History of allergy or hypersensitivity to any of the components of HyBryte.
- A Screening ECG with a QT interval >470 ms (corrected for heart rate using the Fridericia's formula).
- All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.
- Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.
- Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment.
- Patients who have received electron beam irradiation within 3 months of enrollment.
- Patients with a history of significant systemic immunosuppression.
- Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
- Patients whose condition is spontaneously improving.
- Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).
- Patients with extensive skin disease (>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.
- Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.
- Prior participation in the current study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here