New York, New York 10016


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Biopsy-proven basal cell carcinoma on the trunk or extremities - Tumor size ≤ 2 cm in diameter PATIENT CHARACTERISTICS: - Willing and able to comply with all follow-up requirements - Mentally competent - No active, localized, or systemic infections - Not immunocompromised - No coagulation disorder - No photosensitivity or allergy to sunlight - Not pregnant or nursing - No history of keloid formation - No history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis PRIOR CONCURRENT THERAPY: - No prior gold therapy - No prior radiotherapy to the trunk and extremities - More than 24 months since prior oral retinoids (e.g., isotretinoin or acitretin) or photosensitizing drugs (e.g., Declomycin®) - More than 1 year since prior collagen or other injections, Botox® injections, chemical peels, dermabrasion, or resurfacing procedures - More than 1 month since prior topical retinoid therapy - No concurrent aspirin or antioxidants - No concurrent anticoagulation medications


NCT ID:

NCT00747903


Primary Contact:

Diana Santanello
Laser and Skin Surgery Center of New York


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States

Roy G. Geronemus, MD
Phone: 212-686-7306
Email: mail@laserskinsurgery.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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