Study on Treating Mycosis Fungoides with Hypericin Ointment and Light Therapy

Sponsor: Ellen Kim, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05872854

Provider View

This clinical trial is testing a new treatment using a special ointment called HyBryte and visible light to help manage mycosis fungoides, a type of skin lymphoma, over a period of up to 12 months.

Patient Parameters

Program Overview

The aim of this study is to see if using HyBryte ointment along with visible light can help treat mycosis fungoides, a type of skin cancer. Participants will apply the ointment to their skin twice a week, and 24 hours later, the treated areas will be exposed to visible light. The study will last up to 54 weeks, and researchers will monitor specific skin areas to see how well the treatment works. The study is funded by the FDA's Office of Orphan Products Development (OOPD).

Description

In this open-label study, patients with mycosis fungoides will apply HyBryte ointment to their skin lesions twice a week. After 24 hours, these areas will be exposed to visible light to activate the treatment. The study will track 3 to 5 specific lesions, called 'Index Lesions,' to evaluate the treatment's effectiveness using a scoring system every 6 weeks. The treatment will continue until the lesions improve, the patient experiences side effects, or the treatment stops working. Researchers will analyze changes in skin scores to understand how well the treatment works across all participants.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of mycosis fungoides, a type of skin lymphoma, at Stage 1A, 1B, or 2A.
    • Stage 1A: Less than 10% of the skin is affected.
    • Stage 1B: 10% or more of the skin is affected.
    • Stage 2A: Any amount of skin is affected, and lymph nodes are abnormal but not cancerous.
  • Must be willing to follow the study protocol and provide written consent.
  • Female participants must not be pregnant or nursing, must agree to a pregnancy test before starting treatment, and must use effective birth control methods during the study.

Exclusion Criteria

  • Allergy or sensitivity to any components of the treatment.
  • Pregnant or breastfeeding women.
  • Participants not willing to use effective birth control.
  • History of sensitivity to sunlight or certain skin conditions like lupus.
  • Condition is naturally improving without treatment.
  • Use of topical treatments for mycosis fungoides within 2 weeks before joining the study.
  • Use of certain systemic treatments or therapies within 3 weeks before joining the study.
  • Received electron beam radiation within 3 months before joining the study.
  • History of significant immune system suppression.
  • Use of other experimental drugs or substances within 30 days before joining the study.
  • Any condition that might interfere with participation, as judged by the study doctor.
  • Use of drugs that cause sensitivity to light within 2 weeks before starting the treatment, unless no sensitivity was observed after 4 weeks on a stable dose.

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