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Hypericin

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Immunologic Factors

HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 24 (±6) hours later starting at 5 J/cm\^2. Drug application/light sessions will be done twice a week (at least 2 calendar days apart) for up to 54 weeks.

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment

After application of HyBryte (0.25% hypericin ointment), participants will be placed in a light booth containing fluorescent light bulbs to activate the HyBryte.

Visible Light

Cynthia A Clark, PhD, CRNP

Paola Santos, MD

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.

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.

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

Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

A Treatment Response is defined as a ≥50% improvement in the Composite Assessment of Index Lesion Severity (CAILS) score score at each evaluation timepoint (every 6 weeks up to 54 weeks) when compared to the CAILS score at baseline.

The CAILS score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome.

The overall CAILS score is calculated by adding the total score as described above for each of the 3-5 index lesions. A lower score means a better outcome.

A Complete Response is defined as a Modified Severity Weighted Assessment Tool (mSWAT) score of 0 for all lesions at each evaluation timepoint (every 6 weeks up to 54 weeks). The mSWAT is based on an estimate of the percent total area of skin with lesions based on the body surface area (BSA), and the types of lesions present (patch, plaque, or tumor). A lower score means a better outcome.

The Physician Global Assessment (PGA) represents the investigator's assessment of the overall extent of improvement or worsening of the patient's cutaneous disease compared with baseline at each evaluation timepoint (every 6 weeks up to 54 weeks). This assessment is designed to consider all cutaneous lesions, including both index and non-index lesions, using a scale of 0 to 6, as described below:

* 0 completely clear = No evidence of disease; 100% improvement
* 1 almost clear = Very obvious improvement (≥90% to \<100%); only traces of disease remain
* 2 marked improvement = Significant improvement (≥50 to \<90% clear); some evidence of disease remains
* 3 moderate improvement = Intermediate between marked and mild (≥25% to \<50%)
* 4 slight improvement = ≥10% to \<25%; significant evidence of disease remains
* 5 no change = Disease has not changed significantly from baseline (10 to -25%)
* 6 condition worse = Disease is worse than baseline by ≥25%

A ≥50% improvement of the Modified Severity Weighted Assessment Tool (mSWAT) score at each evaluation timepoint (every 6 weeks up to 54 weeks) when compared to the mSWAT score at baseline. The mSWAT score was previously described.

The Visual Analog Scale for itch (VASitch) is a self-evaluation of the amount of itch that the patient has experienced on a visual scale of 0 to 10. A lower score means less itch is experienced. Patients will be asked to to assess the amount of itch they had experienced in the previous 24 hours at every light treatment visit (2 visits per week up to 54 weeks)

The CAILS score was previously described.

The Skindex-29 is a self-administered survey to measure the effects of skin disease on patients' quality of life. Skindex-29 inquires about how often (Never, Rarely, Sometimes, Often, All the time) during the previous four weeks the patient experienced the effect described in each item. Seven items address the Symptoms domain, ten items the Emotional domain, and twelve items the Functioning domain. All responses are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time). Skindex scores are reported as three scale scores, corresponding to the three domains; a scale score is the average of a patient's responses to items in a given domain.

The Patient Benefit Index (PBI) is a self-administered assessment of the patient-reported benefit in the treatment of their skin disease and is calculated based on the Patient Needs Questionnaire (PNQ) at baseline and Patient Needs Questionnaire (PNQ) at treatment time point. Patients with PBI ≥ 1 are considered having at least minimum patient-relevant treatment benefit.

Spots Global Cancer Trial Database for visible light