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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT01292668
Eligibility Criteria:
Inclusion Criteria:
* Patients with 1-2 superficial basal cell carcinoma (sBCC), 0.5 to 2 cm in diameter
* Primary or recurrent lesions may be treated
* Diagnosis must be confirmed by biopsy, at least 2 weeks pre treatment
* Each patient with \< 8 lesions can contribute a maximum of 2 lesions per treatment session, 1 lesion per light source, which can be treated the same day as permitted by scheduling; the remaining lesions may be treated as soon as scheduling permits with non protocol Photodynamic Therapy
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Patients not meeting the above selection criteria
* Lesions which are not suitable for diagnostic measurements
* Patients with \>= 8 lesions to be treated
* Carcinomas of types known to have uncertain clinical margins (e.g. morpheaform or infiltrating), or any lesion felt to require Mohs surgery for definitive control
* Lesions over boney prominences
* Patients with porphyrias or known hypersensitivity to porphyrins
* Patients with known photosensitivity diseases
* Patients with allergies to Metvixia (MAL) cream ingredients (peanut and almond oil)
* Patients previously treated with a systemic photo sensitizer within 4 months
* Pregnant or nursing female patients
* Patients unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01292668
Study Brief:
Protocol Section:
NCT01292668