Treatment of Mycosis Fungoides with Hypericin Ointment and Visible Light

Last updated: January 21, 2025
Sponsor: Ellen Kim, MD
Overall Status: Active - Recruiting

Phase

2

Condition

Cutaneous T-cell Lymphoma

Lymphoproliferative Disorders

Mycosis Fungoides

Treatment

Hypericin

Visible Light

Clinical Study ID

NCT05872854
05622 (UPCC)
RW-HPN-MF-01
851617
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to assess the benefit of continuous treatment with synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks). Funding Source: FDA OOPD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosisfungoides), Stage 1A, Stage 1B, or Stage 2A.

(Stage 1 is divided into stages 1A and 1B as follows: Stage 1A: Patches, papules, and/or plaques cover less than 10% of the skin surface. Stage 1B: Patches, papules, and/or plaques cover 10% or more of the skin surface. Stage 2A: Patches, papules, and/or plaques cover any amount of skin surface. Lymph nodes are abnormal, but they are not cancerous.)

  • Subjects willing to follow the clinical protocol and voluntarily give their writteninformed consent

  • Female subjects not pregnant nor nursing and willing to undergo a pregnancy testwithin 21 days prior to treatment initiation and agree to use a medically acceptedmethod of birth control such as oral contraceptives (birth control pill), Barriermethod (condom plus spermicide or diaphragm plus spermicide) or abstaining fromintercourse while on study

Exclusion

Exclusion Criteria:

  • History of allergy or hypersensitivity to any of the components of SGX301

  • Pregnancy or mothers who are breast-feeding

  • Males and females not willing to use effective contraception

  • Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g.,porphyria, systemic lupus erythematosus, Sjogren's, etc.).

  • Subjects whose condition is spontaneously improving.

  • Subjects receiving topical steroids or other topical treatments (e.g., nitrogenmustard) on lesions for CTCL within 2 weeks of enrollment

  • Subjects receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrowband UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies forCTCL 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 ofenrollment

  • Subject with any condition that, in the judgment of the PI, is likely to interferewith participation in the study

  • Subjects receiving drugs known to cause photosensitization within 2 weeks ofstarting SGX301 therapy unless they have not had evidence of photosensitizationafter receiving a stable dose of the medication for a minimum of 4 weeks.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Hypericin
Phase: 2
Study Start date:
August 21, 2023
Estimated Completion Date:
December 01, 2026

Study Description

This is an open label trial in which patients will have their mycosis fungoides (MF) lesions treated twice a week with HyBryte ointment that is followed, 24 hours later (±6 hours), by activation of the drug with visible light treatment. Patients will treat all of their MF lesions (where accessible to light therapy), but 3 to 5 lesions will be identified and followed as "Index Lesions" that will be evaluated using the Composite Assessment of Index Lesion Severity (CAILS) score every 6 weeks for the up to 54 weeks of therapy. Patients will be treated until resolution, dropout for adverse events, or plateau of therapeutic response occurs. Changes in the skin scoring mechanisms such as the CAILs and mSWAT will be tabulated for each patient and assessed across all patients enrolled in the trial to determine the response profile of HyBryte and visible light treatment.

Connect with a study center

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania 19034
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.