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

PHASE3RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 7, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

October 31, 2026

Conditions
CTCL/ Mycosis FungoidesCTCLMycosis FungoidesCutaneous T Cell Lymphoma
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.

Trial Locations (17)

10032

RECRUITING

Columbia University Medical Center, New York

14450

RECRUITING

Rochester Skin Lymphoma Medical Group, Fairport

15213

RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

17033

RECRUITING

Penn State Health Hershey Medical Center, Hershey

19104

RECRUITING

Hospital of the University of Pennsylvania, Philadelphia

22031

RECRUITING

Inova Schar Cancer Institute, Fairfax

28411

RECRUITING

Accellacare (PMG), Wilmington

33612

RECRUITING

University of South Florida, Tampa

37212

RECRUITING

Vanderbilt University, Nashville

46256

RECRUITING

Dawes Fretzin Dermatology Group, Indianapolis

60611

RECRUITING

Northwestern University, Chicago

63110

RECRUITING

Washington University, St Louis

77030

RECRUITING

MD Anderson, Houston

78660

RECRUITING

Austin Institute for Clinical Research, Pflugerville

85006

RECRUITING

Medical Dermatology Specialists, Phoenix

85259

RECRUITING

Mayo Clinic, Scottsdale

92123

RECRUITING

Therapeutics Clinical Research, San Diego

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Soligenix

INDUSTRY