Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

NCT05872854 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: 05622 (UPCC)RW-HPN-MF-01851617
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycosis Fungoides; Cutaneous T Cell Lymphoma

Keywords

Cutaneous T Cell Lymphoma; Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Responses of Index Lesions

  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.

  Baseline up to 54 weeks

Secondary Outcomes (13)

• The percent of patients achieving a Complete Response of All Lesions

  Baseline up to 54 weeks

• The percent of patients achieving a PGA score of 3 (moderate improvement) from baseline to end of treatment.

  Baseline up to 54 weeks

• The percent of patients achieving at least 50% change in the mSWAT (overall skin score) from baseline to end of treatment.

  Baseline up to 54 weeks

• The percent of patients achieving at least 50% change in VASitch from baseline to end of treatment.

  Baseline up to 54 weeks

• The change in CAILS score for each Index Lesion from baseline to end of treatment.

  Baseline up to 54 weeks.

Study Arms (1)

HyBryte (0.25 % Hypericin) with Visible Light

EXPERIMENTAL

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.

Drug: Hypericin; Other: Visible Light

Interventions

Hypericin DRUG

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment

Also known as: HyBryte, SGX301

HyBryte (0.25 % Hypericin) with Visible Light

Visible Light OTHER

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

Also known as: Fluorescent light

HyBryte (0.25 % Hypericin) with Visible Light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ellen Kim, MD: lead
• Soligenix: collaborator

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19034, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides

Interventions

hypericin; Light; TNTCFP protein

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 24, 2023
• Study Start: August 21, 2023
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)