Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

Trial Title: Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

NCT ID: NCT05872854

Condition: Cutaneous T Cell Lymphoma
Mycosis Fungoides

Conditions: Official terms:
Mycoses
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Hypericin

Conditions: Keywords:
Cutaneous T Cell Lymphoma
Mycosis Fungoides

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: 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).

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Hypericin
Description: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment
Arm group label: HyBryte (0.25 % Hypericin) with Visible Light

Other name: HyBryte

Other name: SGX301

Intervention type: Other
Intervention name: Visible Light
Description: After application of HyBryte (0.25% hypericin ointment), participants will be placed in a light booth containing fluorescent light bulbs to activate the HyBryte.
Arm group label: HyBryte (0.25 % Hypericin) with Visible Light

Other name: Fluorescent light

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage 1A, Stage 1B, or Stage 2A. (Stage 1 is divided into stages 1A and 1B as follows: Stage 1A: Patches, papules, and/or plaques cover less than 10% of the skin surface. Stage 1B: Patches, papules, and/or plaques cover 10% or more of the skin surface. Stage 2A: Patches, papules, and/or plaques cover any amount of skin surface. Lymph nodes are abnormal, but they are not cancerous.) - Subjects willing to follow the clinical protocol and voluntarily give their written informed consent - Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 21 days prior to treatment initiation and agree to use a medically accepted method of birth control such as oral contraceptives (birth control pill), Barrier method (condom plus spermicide or diaphragm plus spermicide) or abstaining from intercourse while on study Exclusion Criteria: - History of allergy or hypersensitivity to any of the components of SGX301 - Pregnancy or mothers who are breast-feeding - Males and females not willing to use effective contraception - Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus, Sjogren's, etc.). - Subjects whose condition is spontaneously improving. - Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on lesions for CTCL within 2 weeks of enrollment - Subjects receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment - Subjects who have received electron beam irradiation within 3 months of enrollment - Subjects with a history of significant systemic immunosuppression - Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment - Subject with any condition that, in the judgment of the PI, is likely to interfere with participation in the study - Subjects receiving drugs known to cause photosensitization within 2 weeks of starting SGX301 therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Perelman Center for Advanced Medicine

Address:
City: Philadelphia
Zip: 19034
Country: United States

Status: Recruiting

Contact:
Last name: Laura Cesar

Phone: 445-800-6538
Email: laura.cesar@pennmedicine.upenn.edu

Start date: August 21, 2023

Completion date: May 31, 2025

Lead sponsor:
Agency: Ellen Kim, MD
Agency class: Other

Collaborator:
Agency: Soligenix
Agency class: Industry

Source: Abramson Cancer Center at Penn Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05872854