Confirmatory Study of Topical HyBryte™

Brief Summary

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

For participation and/or eligibility criteria, visit Clinicaltrials.gov website provided below.


Website: https://clinicaltrials.gov/study/NCT06470451


Sponsor: Soligenix


Detailed Description

The primary objective of this Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patch/plaque phase CTCL compared to patients receiving placebo and visible light.The study will evaluate the efficacy and safety of HyBryte (0.25% hypericin) gel or placebo gel applied twice weekly for 18 weeks. Treated lesions will be covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. All of the participant's lesions that are readily available for exposure to the visible light source will be treated and 3 to 5 index lesions in each patient will be prospectively identified and documented for modified Composite Assessment of Index Lesion Severity (mCAILS) evaluation. Participants will be followed every 4 weeks for a total of 12 weeks following their last light session.


Contacts and Locations

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.


Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06470451

Recruiting

Participating Locations:

Mayo Clinic
Scottsdale, AZ, United States
Principal Investigator
Aaron Mangold, MD
855-776-0015
Recruiting
Washington University School of Medicine
St. Louis, MO, United States
Principal Investigator
Amy Musiek, MD
Contact
Jian Yang
yang983@wustl.edu
314-273-3737
Recruiting
Inova Schar Cancer Institute
Fairfax, VA, United States
Principal Investigator
Jennifer DeSimone, MD
Contact
Kelly Jeffords
kelly.jeffords@inova.org
703-970-6548
Recruiting
Penn State Hershey Dermatology
Hershey, PA, United States
Principal Investigator
Christopher Bazewicz, MD
Contact
Derm Clinical Trials Office
dermatologyclinicaltrials@pennstatehealth.psu.edu
717-531-5136
Recruiting
University of Pennsylvania
Philadelphia, PA, United States
Principal Investigator
Ellen Kim, MD
Contact
Laura Cesar
laura.cesar@pennmedicine.upenn.edu
445-800-6538
Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, IN, United States
Principal Investigator
Kenneth Dawes, MD
Contact
Lana Johnson
ljohnson2e902@ecommunity.co
317-516-5030 Ext. 109
Recruiting
Therapeutics Clinical Research
San Diego, CA, United States
Principal Investigator
Neal Bhatia, MD
Contact
Hector Bailon
hbailon@therapeuticsresearch.com
858-571-6800 Ext. 141
Recruiting
Austin Institute for Clinical Research
Pflugerville, TX, United States
Principal Investigator
Edward Lain, MD
Contact
Tommy Ha
tha@atxresearch.com
512-279-2545
Recruiting
Rochester Skin Lymphoma Medical Group, PLLC
Fairport, NY, United States
Principal Investigator
Brian Poligone, MD
Contact
Lily Hauschildt
hauschildt@roclymphoma.com
585-364-1188
Recruiting
Medical Dermatology Specialists
Phoenix, AZ, United States
Principal Investigator
Nathalie Zeitouni, MD
Contact
Kayla Heraty
kheraty@usdermpartners.com
602-354-5770 Ext. 4276
Recruiting
UT MD Anderson Cancer Center
Houston, TX, United States
Principal Investigator
Auris Huen, MD
Contact
Alda Ashu
abmiraso@mdanderson.org
713-792-1280
Recruiting
Accellacare
Wilmington, NC, United States
Principal Investigator
James Appel, MD
Contact
Allison Migliarese
allison.migliarese@accellacare.com
910-799-5500
Recruiting