UPCC 05624 A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
Brief description of study
The purpose of this trial is to evaluate the safety and efficacy of 18 weeks of HyBryte treatment in combination with visible light therapy in subjects 18 years and older with cutaneous T-cell lymphoma when compared to placebo. Procedures include vital signs, physical examination, review of medical history, blood tests, review of past and current medications, digital photography, visible light treatment (phototherapy), ECG, subject questionnaires, and skin assessments.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 99 years or below
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Gender: All
Inclusion Criteria
1. ≥18 years of age.
2. Patients must have a clinical diagnosis of CTCL (MF), Stage IA, Stage IB, or Stage IIA.
3. Patients with a minimum of three (3) evaluable, discrete lesions.
4. Patients willing to follow the clinical protocol and voluntarily give their written informed consent.
5. Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.
Exclusion Criteria
1. History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren’s syndrome, xeroderma pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling.
2. History of allergy or hypersensitivity to any of the components of HyBryte.
3. A Screening ECG with a QT interval >470 ms (corrected for heart rate using the Fridericia’s formula).
4. Pregnancy or mothers who are breast-feeding.
5. All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.
6. Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.
7. Patients 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 4 weeks of enrollment.
8. Patients who have received electron beam irradiation within 3 months of enrollment.
9. Patients with a history of significant systemic immunosuppression.
10. Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
11. Patients whose condition is spontaneously improving.
12. Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).
13. Patients with extensive skin disease (>30% BSA) who would be, in the judgement of the PI, candidates for systemic treatment.
14. Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.
15. Prior participation in the current study.
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