Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSoligenix
About this trial
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- Hypericin
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
17Arizona
Medical Dermatology Specialists85006, Phoenix United States
Mayo Clinic85259, Scottsdale United States
California
Therapeutics Clinical Research92123, San Diego United States
Florida
University of South Florida33612, Tampa United States
Sponsors and collaborators
Soligenix
Lead sponsor
Source ClinicalTrials.gov