Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06470451
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06470451
Study Brief:
Protocol Section:
NCT06470451