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

NCT ID: NCT06149247

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2024-06-27

Brief Summary

The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.

Detailed Description

Participants will be randomized to receive HyBryte or Valchlor in a 1:1 randomization. Participants will be treated for 12 weeks and follow-up visits will be conducted 1, 2, and 4 weeks after completion of the treatment phase of the trial.

Prior to randomization, each participant will have at least 3 and up to 5 lesions identified (index lesions) that will be evaluated during the treatment phase and during the follow-up visits.

Conditions

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HyBryte (0.25 % hypericin)

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 Type: EXPERIMENTAL

Hypericin

Intervention Type: DRUG

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.

Valchlor (mechlorethamine)

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

Group Type: ACTIVE_COMPARATOR

Mechlorethamine Topical Gel

Intervention Type: DRUG

Valchlor is an FDA-approved drug for the treatment of CTCL.

Interventions

Hypericin

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.

Intervention Type: DRUG

Mechlorethamine Topical Gel

Valchlor is an FDA-approved drug for the treatment of CTCL.

Intervention Type: DRUG

Other Intervention Names

HyBryte; SGX301; Valchlor

Eligibility Criteria

Inclusion Criteria

• 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
• Subjects willing to follow the clinical protocol and voluntarily give their written informed consent
• Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation

Exclusion Criteria

• History of severe allergic reaction to any of the components of HyBryte or mechlorethamine (Valchlor)
• Pregnancy or mothers who are breast-feeding
• All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception
• Subjects with history of sun hypersensitivity or photosensitive dermatoses (eg, porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
• Subjects whose condition is spontaneously improving
• Subjects receiving Valchlor (or any topical compound containing Mechlorethamine) in the preceding 2 months
• Subjects receiving topical steroids or other topical treatments (eg, targretin gel) on treatment accessible lesions for CTCL within 2 weeks of enrollment
• Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
• Subjects who have received electron beam irradiation within 3 months of enrollment
• Subjects with a history of significant systemic immunosuppression
• Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
• Subject has any condition that, in the judgment of the Investigator, is likely to interfere with participation in the study
• Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soligenix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rochester Skin Lymphoma Medical Group

Fairport, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HPN-CTCL-04

Identifier Type: -

Identifier Source: org_study_id