Study Comparing HyBryte™ Gel and Placebo for Treating Skin Lymphoma

Sponsor: Soligenix

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06470451

Provider View

This clinical trial is testing a topical gel called HyBryte™ to see if it can help treat a type of skin lymphoma known as cutaneous T-cell lymphoma (CTCL) in its early stages. The study will compare the effects of HyBryte™ with a placebo gel.

Patient Parameters

Program Overview

The study aims to find out if an 18-week treatment using HyBryte™ gel, combined with visible light, can improve skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL). Participants will apply either HyBryte™ gel or a placebo gel twice a week. After applying the gel, the treated areas will be covered and then exposed to visible light about 21 hours later. The study will track the changes in specific skin lesions over time to assess the treatment's effectiveness and safety. Participants will have follow-up visits every four weeks for 12 weeks after their last light treatment.

Description

This Phase 3 study is designed to evaluate the effectiveness and safety of HyBryte™ gel, which contains 0.25% hypericin, in treating early-stage cutaneous T-cell lymphoma (CTCL). Participants will apply the gel to their skin lesions twice a week for 18 weeks. After applying the gel, the lesions will be covered with opaque material and exposed to visible light approximately 21 hours later. The study will focus on specific lesions identified at the start for detailed assessment. Participants will be monitored every four weeks for 12 weeks after completing the light treatments to evaluate the treatment's impact and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with early-stage cutaneous T-cell lymphoma (CTCL), specifically Stage IA, IB, or IIA.
  • Have at least three separate skin lesions that can be evaluated.
  • Willing to follow the study procedures and provide written consent.
  • Female participants must not be pregnant or nursing and must agree to a pregnancy test before starting treatment.

Exclusion Criteria

  • History of sensitivity to sunlight or certain skin conditions like lupus or porphyria.
  • Allergic to any ingredients in HyBryte™.
  • Abnormal heart rhythm as shown by an ECG test.
  • Not willing to use effective birth control if of childbearing potential.
  • Using other topical treatments for CTCL within two weeks before the study.
  • Using systemic treatments like certain light therapies or medications for CTCL within four weeks before the study.
  • Received electron beam radiation within three months before the study.
  • History of significant immune system suppression.
  • Taking other experimental drugs or substances within 30 days before the study.
  • Condition is naturally improving without treatment.
  • Have more advanced stages of CTCL or extensive skin disease covering more than 30% of the body.
  • Any condition that might interfere with participating in the study.
  • Previously participated in this study.

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