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Hypericin vs Mechlorethamine for Cutaneous T-Cell Lymphoma

Phase 2

Recruiting

Research Sponsored by Soligenix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum of 3 active treatment-accessible CTCL lesions

Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IA, IB, or Stage IIA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial compares two medications to see which is safer and more effective after 12 weeks of treatment.

Who is the study for?

This trial is for individuals with a specific skin cancer called CTCL, stages IA to IIA. Participants must have at least 3 treatable lesions and not be pregnant or nursing. They should agree to use contraception and not have allergies to the study drugs, photosensitivity disorders, or recent treatments with similar medications.Check my eligibility

What is being tested?

The trial compares two topical gels: HyBryte (Synthetic Hypericin) and Valchlor (Mechlorethamine), over a period of 12 weeks. The goal is to determine which one is safer and more effective in treating CTCL.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to ingredients in either gel, skin irritation at the application site, increased sensitivity to sunlight due to Hypericin, and other local or systemic reactions as per individual tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have at least 3 treatable skin cancer lesions.

Select...

I have been diagnosed with early-stage cutaneous T-cell lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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 Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) 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%

Study treatment Arm

HyBryte (0.25 % Hypericin)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

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 6 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 12 weeks.

Group II: Valchlor (mechlorethamine)Active Control1 Intervention

Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypericin

2022

Completed Phase 2

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SoligenixLead Sponsor

9 Previous Clinical Trials

805 Total Patients Enrolled

Frequently Asked Questions

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

Is there still capacity for individuals to enroll in this trial?

"As stated on clinicaltrials.gov, this medical trial is not presently enrolling any participants; however, the initial listing was posted in November 1st 2023 and recently updated on 11/20/2023. Despite its current hiatus, 87 other studies are actively sourcing patients right now."

Answered by AI

Has the FDA sanctioned HyBryte (0.25 % hypericin) for medical use?

"The safety of HyBryte (0.25 % hypericin) was assessed as a 2, since it is only in its second testing phase and there has been no evidence yet supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

2023. "HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06149247.

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