Treatment for Mycosis Fungoides using Hypericin Ointment and Light
Treatment of Mycosis Fungoides with Hypericin Ointment and Visible Light
This study is testing if a new ointment combined with light therapy can help people with mycosis fungoides, a type of skin cancer, feel better by reducing their skin lesions.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05872854 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of synthetic hypericin ointment (HyBryte) combined with visible light therapy in treating patients with mycosis fungoides, a type of cutaneous T-cell lymphoma. Participants will apply the ointment twice a week, followed by light activation 24 hours later. The trial will last up to 54 weeks, during which the severity of lesions will be monitored using specific scoring systems. The study is designed to assess the therapeutic response and safety of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with stage 1A, 1B, or 2A mycosis fungoides who are willing to adhere to the treatment protocol.
Not a fit: Patients with advanced stages of cutaneous T-cell lymphoma or those with contraindications to the treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from mycosis fungoides.
How similar studies have performed: While there have been studies exploring light therapy for skin conditions, the combination of hypericin ointment and visible light is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Laura Cesar
- Email: laura.cesar@pennmedicine.upenn.edu
- Phone: 4458006538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.