Spots Global Cancer Trial Database for Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial