A prospective clinical, uncontrolled, open-label, explorative phase 2a trial on patients with histologically-confirmed superficial and nodular basal cell carcinoma (BCC). The study assesses tolerability and tumor clearance after laser-assisted topical delivery of topical ingenol mebutate.
Patients will receive ablative fractional laser (AFXl)-assisted ingenol mebutate (IM) as a treatment for their cutaneous basal cell carcinoma (BCC). Treatment areas consisting of tumors and a 5 mm margin will undergo AFXl exposure (CO2 laser) followed by IM 0.015% or 0.05% under occlusion for 2-3 days. . local skin reactions are monitored at baseline (day1), day 3/4, day 8, day 15, day 29, day 90, and tumor response monitored at baseline, day 29, and day 90. An additional repeat AFXl-IM treatment on day 29 will be offered if tumors persist, based on clinical evaluation and imaging on day 30. Primary outcome: 1. severity and duration of clinical local skin reactions including erythema, scaling, edema, blistering, erosion/ulceration and crusting using a 0-4-point scale at all visits from baseline to day 90. 2. To monitor BCC tumor response on clinical assessments supported by non-invasive imaging techniques including optical coherence tomography (OCT) and reflectance confocal microscopy (RCM) at baseline, day 29 and day 90.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will receive ablative fractional laser (AFXl)-assisted ingenol mebutate (IM) as a treatment for their cutaneous basal cell carcinoma (BCC). Treatment areas consisting of tumors and a 5 mm margin will undergo AFXl exposure (CO2 laser) followed by IM 0.015% or 0.05% under occlusion for 2-3 days. . local skin reactions are monitored at baseline (day1), day 3/4, day 8, day 15, day 29, day 90, and tumor response monitored at baseline, day 29, and day 90. An additional repeat AFXl-IM treatment on day 29 will be offered if tumors persist, based on clinical evaluation and imaging on day 30.
Department of Dermtology, Bispebjerg University Hospital, Copenhagen, Denmark
Copenhagen, Denmark
Change in occurrence of local skin reactions
Non-blinded, clinical evaluation of local erythema, edema, flaking, crusting/scabbing, pustulation, scarring, hypo(hyperpigmentation, infection in treated areas will be performed by physician using an FDA-approved 0-4 point lsr scale at day 1, 3/4, 8, 15, 29 and 90 after AFXl exposure. Standardized, clinical photographs are taken to document skin reactions at each visit
Time frame: 0-90 days
Tumor response clinically
Tumor clearance (yes or no) will be evaluated clinically at baseline, at day 29 and day 90. If residual tumor is identified at day 90 patients will receive conventional treatment according to national guidelines.
Time frame: baseline, day 29, day 90
Tumor response by imaging techniques
Clearance (yes or no) will be evaluated using non-invasive reflectance confocal microscopy and optical coherence tomography at baseline, day 30 and day 90.f residual tumor is identified at day 90 patients will receive conventional treatment according to national guidelines.
Time frame: baseline, day 29, day 90
Tumor response - histology
HIstological verification of tumor clearance will be performed at day 90 after first treatment using tissue sections from a punch biopsy (up to 4 mm). If residual tumor is identified at day 90 patients will receive conventional treatment according to national guidelines.
Time frame: At day 90
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