TrialCompass TCL
Find TrialsAI AssistantLetter GeneratorAbout
Back to results
Phase 3RecruitingPriority 1 · Highest priorityNCT06470451

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

ClinicalTrials.gov

Plain-language summary

This Phase 3 trial is studying Hypericin and Placebo for people with cutaneous T-cell lymphoma (skin lymphoma). Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 17 US locations across multiple states.

Who can join (key eligibility)

  • Age 18 Years or older
  • See full trial listing for complete eligibility

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Hypericin (DRUG): 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. | Placebo (DRUG): 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.

Drugs / treatments
Hypericin, Placebo
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 3
Status
Recruiting
Design
Randomized, quadruple blind
Enrollment target
80 patients
Primary endpoint
Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score
Ages
18 Years to —
Start date
2025-01-07
Est. completion
2026-10

Locations

17 US sites · 17 total

ArizonaCaliforniaFloridaIllinoisIndianaMissouriNew YorkNorth CarolinaPennsylvaniaTennesseeTexasVirginia

Contact

Sponsor
Soligenix (INDUSTRY)
Contact
Jennifer Bonfrisco | jbonfrisco@soligenix.com | 609-538-8200

Tags

CTCLany
TrialCompass — Clinical Trial Summary

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

NCT06470451

Phase: Phase 3 | Status: Recruiting | Priority: Highest

Plain-language summary

This Phase 3 trial is studying Hypericin and Placebo for people with cutaneous T-cell lymphoma (skin lymphoma). Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 17 US locations across multiple states.

Who can join

  • Age 18 Years or older
  • See full trial listing for complete eligibility

What's being tested

Hypericin (DRUG): 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. | Placebo (DRUG): 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.

Drugs / treatments: Hypericin, Placebo

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Randomized, quadruple blind

Enrollment target: 80 patients

Primary endpoint: Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score

Ages: 18 Years to —

Start date: 2025-01-07 | Est. completion: 2026-10

Locations

17 US sites · 17 total

Arizona, California, Florida, Illinois, Indiana, Missouri, New York, North Carolina, Pennsylvania, Tennessee, Texas, Virginia

Contact

Jennifer Bonfrisco | jbonfrisco@soligenix.com | 609-538-8200

Sponsor: Soligenix (INDUSTRY)

Tags

CTCL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06470451

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
TrialCompass

A free tool to help patients, caregivers, and clinicians find and understand clinical trials for T-cell lymphoma.

Explore

  • Find Trials
  • AI Assistant
  • Letter Generator
  • About
  • Share Your Feedback
  • Terms of Use
  • Privacy Policy

Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

Edit with