RECRUITING

Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

Conditions

Cutaneous T Cell Lymphoma Mycosis Fungoides

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

Quick Facts

Study Start:2023-08-21

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05872854

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage 1A, Stage 1B, or Stage 2A. * 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	* 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.

Inclusion Criteria

Exclusion Criteria

* Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage 1A, Stage 1B, or Stage 2A.
* 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

* 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.

Contacts and Locations

Study Contact

Laura Cesar

CONTACT

4458006538

laura.cesar@pennmedicine.upenn.edu

Study Locations (Sites)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19034

United States

Collaborators and Investigators

Sponsor: Ellen Kim, MD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-21

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2023-08-21

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

Cutaneous T Cell Lymphoma
Mycosis Fungoides

Additional Relevant MeSH Terms

Cutaneous T Cell Lymphoma
Mycosis Fungoides