Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

Description

To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Conditions

CTCL/ Mycosis Fungoides, CTCL, Mycosis Fungoides, Cutaneous T Cell Lymphoma

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Study Overview

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Study Details

Study overview

To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

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)

Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

Condition
CTCL/ Mycosis Fungoides
Intervention / Treatment

-

Contacts and Locations

Phoenix

Medical Dermatology Specialists, Phoenix, Arizona, United States, 85006

Scottsdale

Mayo Clinic, Scottsdale, Arizona, United States, 85259

San Diego

Therapeutics Clinical Research, San Diego, California, United States, 92123

Indianapolis

Dawes Fretzin Dermatology Group, Indianapolis, Indiana, United States, 46256

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Fairport

Rochester Skin Lymphoma Medical Group, Fairport, New York, United States, 14450

New York

Columbia University Medical Center, New York, New York, United States, 10032

Wilmington

Accellacare (PMG), Wilmington, North Carolina, United States, 28411

Philadelphia

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Houston

MD Anderson, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Soligenix,

Study Record Dates

2026-10