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Photosensitizer

HyBryte (0.25 % Hypericin) for Cutaneous T-Cell Lymphoma

Phase 2
Waitlist Available
Research Sponsored by Soligenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.

Eligible Conditions
  • Cutaneous T-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Electrocardiograms (ECG)
Systemic Blood Levels
Secondary outcome measures
Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.
Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.

Side effects data

From 2022 Phase 2 trial • 9 Patients • NCT05380635
11%
Chills
11%
Pruritis
11%
Urticaria
11%
Photosensitivity reaction
11%
Coronavirus infection
11%
Skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
HyBryte (0.25 % Hypericin)

Trial Design

1Treatment groups
Experimental Treatment
Group I: HyBryte (0.25 % Hypericin)Experimental Treatment1 Intervention
HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypericin
2022
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

SoligenixLead Sponsor
9 Previous Clinical Trials
806 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma
2022. "PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05380635.
~3 spots leftby Apr 2025
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