Conditions: Basal Cell Nevus Syndrome
Keywords: Basal Cell Nevus Syndrome Gorlin's Syndrome
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved method widely used currently for squamous precancers of the skin. The investigators hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study will investigate whether there are any differences in tumor clearance between the Blu-U® (blue lamp) and Aktilite™(red lamp) therapies.

Detailed description:
This is a pilot intra-patient comparative study to evaluate the ability of cyclic Photodynamic Therapy (PDT) using Red (635 nm) or Blue (400 nm) light with 5-Aminolevulinic acid, to eliminate BCC skin cancers that occur in patients with Basal Cell Nevus Syndrome (Gorlin-Goltz Syndrome).

Patients will receive 3 cycles of Red light and Blue light PDT treatments, for a total of 6 treatments, over a 4 month period. Cycles will be spaced 2 months apart. Each cycle consists of a double course of PDT treatment with treatments spaced one week apart. Every subject will be treated with two light sources, blue and red, according to randomized assignments made to left side or right side of the body. There will be a final assessment visit at month 6.

Arms:
arm 1: The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT.

Interventions: intervention 1: Levulan intervention 2: Red Light PDT intervention 3: Blue Light PDT
Intervention descriptions: intervention 1: Levulan application followed by Red or Blue light PDT intervention 2: Aktilite™ (red lamp) after Levulan application on lesions intervention 3: Blu-U® (blue lamp) after Levulan application on lesions

Protocol document: