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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

RW-HPN-MF-01 Trial 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.Check my eligibility

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.See study design

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.

RW-HPN-MF-01 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Treatment Responses of Index Lesions

Secondary outcome measures

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

RW-HPN-MF-01 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

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Office of Orphan Products DevelopmentUNKNOWN

Ellen Kim, MDLead Sponsor

SoligenixIndustry Sponsor

10 Previous Clinical Trials

790 Total Patients Enrolled

3 Trials studying Mycosis Fungoides

188 Patients Enrolled for Mycosis Fungoides

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this investigation still accessible to individuals?

"According to the information accessible on clinicaltrials.gov, this trial is actively recruiting participants. The entry for the study was created on August 21st 2023 and it has since been modified as recently as October 27th 2023."

Answered by AI

What is the current total of participants in this clinical research?

"Affirmative. According to information on clinicaltrials.gov, this healthcare trial is actively recruiting at present. It was initially posted on August 21st 2023 and last updated October 27th of the same year. The goal is to recruit 50 subjects from one medical centre."

Answered by AI

Has the FDA sanctioned HyBryte (0.25 % Hypericin) with Visible Light?

"With 0.25% Hypericin and exposure to visible light, the safety of HyBryte received a score of 2 given that it has only been tested in Phase 2 trials where efficacy is yet unproven but some data exists validating its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

Ellen Kim, MD 2023. "Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05872854.

All > Mycosis Fungoides