Non-melanomatous Skin Cancer Clinical Trial
Official title:
Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a
certain kind of light. When the drug is active, tumor cells are killed. This may be an
effective treatment against skin cancer.
PURPOSE: This phase II trial is studying the side effects of photodynamic therapy using
aminolevulinic acid and to see how well it works in treating patients with skin cancer.
OBJECTIVES:
- To determine the safety and efficacy of intralesional photodynamic therapy using
aminolevulinic acid and non-coherent blue light in patients with nodular basal cell
carcinoma.
OUTLINE: Patients undergo photodynamic therapy comprising intralesional injection of
aminolevulinic acid followed by non-coherent blue light therapy over approximately 17
minutes. Patients may undergo re-treatment with photodynamic therapy 8 weeks later.
Patients undergo photographic assessment of their skin lesions at baseline, 8 weeks, 16
weeks, and then at 1 and 2 years to evaluate healing time, clinical improvement, and side
effects.
Patients undergo biopsies of their skin lesions at 16 weeks and then at 1 and 2 years to
confirm histological clearance.
;
Masking: Open Label, Primary Purpose: Treatment
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