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NCT06470451 · ClinicalTrials.gov registry record · Phase 3
Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
A Phase 3 study of Cutaneous T Cell Lymphoma and Mycosis Fungoides, sponsored by Soligenix.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
- 17
- Study locations
NCT06470451: Recruiting Phase 3 study of Cutaneous T Cell Lymphoma and Mycosis Fungoides, sponsored by Soligenix.
NCT06470451 is a Phase 3 study of Cutaneous T Cell Lymphoma and Mycosis Fungoides that is actively recruiting participants, run by Soligenix. The registered enrollment target is 80 participants, above the 64-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (25% higher). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06470451, a Phase 3 study of Cutaneous T Cell Lymphoma and Mycosis Fungoides, is actively recruiting participants, sponsored by Soligenix.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
- 17
- Study locations
Study Summary
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Primary Outcome
A treatment response is defined as a ≥50% improvement in the cumulative mCAILS score of the index lesions at Week 18 when compared to the mCAILS score at baseline. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin lev
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hypericin
Study Locations (17)
Pennsylvania
- Penn State Health Hershey Medical Center - Hershey
- Hospital of the University of Pennsylvania - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Arizona
- Medical Dermatology Specialists - Phoenix
- Mayo Clinic - Scottsdale
New York
- Rochester Skin Lymphoma Medical Group - Fairport
- Columbia University Medical Center - New York
Texas
- MD Anderson - Houston
- Austin Institute for Clinical Research - Pflugerville
California
- Therapeutics Clinical Research - San Diego
Florida
- University of South Florida - Tampa
Illinois
- Northwestern University - Chicago
Indiana
- Dawes Fretzin Dermatology Group - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-01-07 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
What NCT06470451 shows while recruiting
NCT06470451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 64-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (25% higher).
The record links to 4 conditions, with Cutaneous T Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06470451 lists 17 locations in 12 states (Pennsylvania, Arizona, New York).
Frequently Asked Questions
What is clinical trial NCT06470451 about?
NCT06470451 is a clinical study titled "Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL". To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
What is the current status of trial NCT06470451?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2025-01-07. Estimated completion is 2026-10.
What conditions does trial NCT06470451 study?
This clinical trial studies the following conditions: Cutaneous T Cell Lymphoma, Mycosis Fungoides, CTCL, CTCL/ Mycosis Fungoides.
What interventions are being tested in trial NCT06470451?
The interventions under investigation include: Placebo (DRUG), Hypericin (DRUG).
Who is sponsoring clinical trial NCT06470451?
This trial is sponsored by Soligenix, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06470451 being conducted?
This trial has 17 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cutaneous T Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06470451's enrollment target sits among peer trials
80 6th of 23 higher than 18 of 23 other Cutaneous T Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cutaneous T Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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