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Hypericin

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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.

Soligenix

Ellen Kim, MD

Principal Investigator

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated.

Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment.

Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

SGX301 (synthetic hypericin)

USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Placebo

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma

The percentage of patients achieving a treatment response in each of the 2 treatment groups. A treatment response was defined as a ≥50% improvement in CAILS score at Week 8 when compared to the CAILS score at baseline.

The Composite Assessment of Index Lesion Disease Severity (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 was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.

The percentage of patients achieving a treatment response at Week 16 that received SGX301 for both Cycle 1 and 2 compared to the response rate in patients that received Placebo in Cycle 1.

The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

The percentage of patients achieving a treatment response at Week 24 compared at Week 16 in SGX301 treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline.

The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

The proportion of patch lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions.

The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

The proportion of plaque lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions.

The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

Cycle 1 - SGX301

Patients treated with Placebo in Cycle 1. Cycle 1 is the only cycle that used Placebo.

Cycle 1 - Placebo

Patients treated with SGX301 in Cycle 2. Since all patients received SGX301 in Cycle 2, this includes 45 patients that received Placebo in Cycle 1 and 110 patients that continued to receive SGX301 in Cycle 2.

Cycle 2 - SGX301

Patients treated with SGX301 in Cycle 3. Since all patients received SGX301 in Cycle 3, this includes 32 patients that received Placebo in Cycle 1 and 78 patients that continued to receive SGX301 in Cycle 3.

Cycle 3 - SGX301

Any participant that received at least one dose of SGX301 during any cycle of the trial.

Overall SGX301

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated.

Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment.

Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).

SGX301 (synthetic hypericin): 0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

SGX301

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Placebo: USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Asian

Native Hawaiian or Other Pacific Islander

American Indian or Alaska Native

Other

Unknown

Race/Ethnicity, Customized

The baseline analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo)

Richard Straube, MD/Chief Medical Officer

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Cycle 1: Patients have three (3) index lesions treated with Placebo (USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo)

Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Cycle 2: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

SGX301 (Cycle 1 & 2 = SGX301)

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Cycle 1: Patients have three (3) index lesions treated with Placebo (USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 12 J/cm\^2 fluorescent light.

Placebo (Cycle 1)

The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301) in Cycle 2

Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo)

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Cycle 2: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Cycle 3: Patients have three (3) index lesions treated with SGX301 (0.25% synthetic hypericin in USP Hydrophilic Ointment) applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

SGX301 (Cycle 1, 2 & 3 = SGX301)

Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301

Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)

The analysis population was defined as all lesions that were treated with at least one dose of treatment (SGX301) in Cycle 2

Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Placebo: USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 18-24 hours, then treated with an initial dose of 12 J/cm\^2 fluorescent light.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light	NCT05872854	Cutaneous T Cel... Mycosis Fungoid...	Hypericin Visible Light	18 Years -	Abramson Cancer Center at Penn Medicine
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)	NCT02448381	Cutaneous T-Cel...	SGX301 (synthet... Placebo	18 Years -	Soligenix
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)	NCT02448381	Cutaneous T-Cel...	SGX301 (synthet... Placebo	18 Years -	Soligenix
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)	NCT02448381	Cutaneous T-Cel...	SGX301 (synthet... Placebo	18 Years -	Soligenix
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)	NCT02448381	Cutaneous T-Cel...	SGX301 (synthet... Placebo	18 Years -	Soligenix

Spots Global Cancer Trial Database for hypericin

Every month we try and update this database with for hypericin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hypericin

Every month we try and update this database with for hypericin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hypericin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.