Status:
COMPLETED
PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma
Lead Sponsor:
Soligenix
Conditions:
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.
Eligibility Criteria
Inclusion
- A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA
- CTCL lesions covering ≥ 10% of their body surface area
Exclusion
- History of allergy or hypersensitivity to any of the components of HyBryte
- 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 (SLE), Sjogren's syndrome, etc.)
- Subjects whose condition is spontaneously improving
- Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index lesions for CTCL within 2 weeks of enrollment
- Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (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
- Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05380635
Start Date
May 9 2022
End Date
August 16 2022
Last Update
June 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rochester Skin Lymphoma Medical Group
Fairport, New York, United States, 14450