Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

Launched by SOLIGENIX · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called HyBryte, which is a special cream used to help patients with a type of skin cancer known as cutaneous T-cell lymphoma (CTCL), specifically during the patch or plaque phase. The goal is to see how effective HyBryte is compared to a placebo (a treatment that doesn’t contain active medicine) in reducing skin lesions caused by this condition. The trial is currently looking for participants aged between 65 and 74, regardless of gender, who have a confirmed diagnosis of early-stage CTCL and at least three visible skin lesions.

To be eligible, participants must agree to follow the study guidelines and provide written consent. Women who can become pregnant must be tested to ensure they are not pregnant and agree to use contraception during the study. However, certain individuals, such as those with a history of severe skin sensitivity to sunlight, recent radiation treatment, or other specific health conditions, cannot participate. If you decide to join the trial, you can expect regular visits to the clinic for treatment and monitoring, and you'll be helping researchers learn more about this potential new therapy for CTCL.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.
• • Patients with a minimum of three (3) evaluable, discrete lesions.
• • Patients willing to follow the clinical protocol and voluntarily give their written informed consent.
• • Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.
• Exclusion Criteria:
• • 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.
• • History of allergy or hypersensitivity to any of the components of HyBryte.
• • A Screening ECG with a QT interval \>470 ms (corrected for heart rate using the Fridericia's formula).
• • All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.
• • Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.
• • 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.
• • Patients who have received electron beam irradiation within 3 months of enrollment.
• • Patients with a history of significant systemic immunosuppression.
• • Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
• • Patients whose condition is spontaneously improving.
• • Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).
• • Patients with extensive skin disease (\>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.
• • Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.
• • Prior participation in the current study.