Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

Description

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.

Conditions

Cutaneous T Cell Lymphoma, Mycosis Fungoides

Study Overview

Study Details

Study overview

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.

Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

Condition
Cutaneous T Cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States, 19034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage 1A, Stage 1B, or Stage 2A.
  • * 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 21 days prior to treatment initiation and agree to use a medically accepted method of birth control such as oral contraceptives (birth control pill), Barrier method (condom plus spermicide or diaphragm plus spermicide) or abstaining from intercourse while on study
  • * 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., nitrogen mustard) on lesions for CTCL within 2 weeks of enrollment
  • * Subjects receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band 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 with any condition that, in the judgment of the PI, is likely to interfere with participation in the study
  • * Subjects receiving drugs known to cause photosensitization within 2 weeks of starting SGX301 therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ellen Kim, MD,

Study Record Dates

2025-05-31