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RECRUITING
NCT06470451
PHASE3

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

Sponsor: Soligenix

View on ClinicalTrials.gov

Summary

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

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-01-07

Completion Date

2026-10

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

Hypericin

HyBryte gel (0.25% hypericin) is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.

DRUG

Placebo

Placebo gel is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.

Locations (17)

Medical Dermatology Specialists

Phoenix, Arizona, United States

Mayo Clinic

Scottsdale, Arizona, United States

Therapeutics Clinical Research

San Diego, California, United States

University of South Florida

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, United States

Washington University

St Louis, Missouri, United States

Rochester Skin Lymphoma Medical Group

Fairport, New York, United States

Columbia University Medical Center

New York, New York, United States

Accellacare (PMG)

Wilmington, North Carolina, United States

Penn State Health Hershey Medical Center

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

MD Anderson

Houston, Texas, United States

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States