Hypericin Ointment + Visible Light for Mycosis Fungoides (RW-HPN-MF-01 Trial)

Phase 2

Recruiting

Research Sponsored by Ellen Kim, MD

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 baseline up to 54 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a synthetic ointment and light can help treat mycosis fungoides for up to a year. Funded by FDA OOPD.

Who is the study for?

This trial is for individuals with a specific skin cancer called mycosis fungoides, stages 1A to 2A. Participants must be willing to follow the study rules and not be pregnant or breastfeeding. They should use birth control and cannot have allergies to the treatment components or conditions that worsen with light exposure.

What is being tested?

The trial tests synthetic hypericin ointment (HyBryte) combined with visible light on patients over a period of up to 12 months. The aim is to see if this continuous treatment benefits those suffering from mycosis fungoides.

What are the potential side effects?

Potential side effects may include reactions at the application site, sensitivity to light, and possible allergic responses. Since it involves visible light therapy, there might also be risks related to prolonged light exposure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 54 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 54 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 54 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Treatment Responses of Index Lesions

Secondary study objectives

Change in Patient Benefit Index score at Week 12, Week 24, Week 36 and Week 54

Change in Skindex-29 score at Week 12, Week 24, Week 36 and Week 54

The change in CAILS score for each Index Lesion from baseline to end of treatment.

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HyBryte (0.25 % Hypericin) with Visible LightExperimental Treatment2 Interventions

HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 24 (±6) hours later starting at 5 J/cm\^2. Drug application/light sessions will be done twice a week (at least 2 calendar days apart) for up to 54 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypericin

2022

Completed Phase 2

~20

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