Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Efficacy
Safety
次要结局
未报告次要终点