2026-526649-85-00招募中4 期
Evaluation of the efficacy and safety of photodynamic therapy with BF-200 ALA (Ameluz®) in immunosuppressed patients with actinic keratoses and superficial basal cell carcinoma at any location.
Dra. Elena González Guerra3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- The complete clearance rate of lesions at 3 months, defined as the complete clinical disappearance of the treated lesion.
研究概览
简要总结
Evaluate the efficacy and safety of photodynamic therapy (PDT) with BF-200 ALA in immunosuppressed patients compared to non-immunosuppressed patients with grade I–II actinic keratosis and superficial basal cell carcinoma.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Immunosuppressed patients (transplant recipients and those with hematological diseases, specifically chronic lymphocytic leukemia and multiple myeloma)
- •Clinical and histological diagnosis of grade I/II actinic keratoses (3 to 9 AKs) and/or basal cell carcinomas (1 to 3 BCCs, 0.5 to 2 cm in diameter, located on the face/scalp, neck, trunk, or extremities)
- •Ability to provide informed consent
- •Availability for follow-up at 3, 6, and 12 months
排除标准
- •Known allergy to 5-ALA, peanuts, soy, or any component of BF-200 ALA
- •Porphyria or other photosensitive disorders
- •Pregnancy or breastfeeding
- •Use of topical treatments in the treatment area within the previous 12 weeks or during the study
- •Prior treatment in the target area with more than 5 therapies before the study, to avoid treatment-resistant actinic keratoses
- •Participation in a clinical trial within the last 30 days
- •Treatment with substances with phototoxic or photoallergic potential within the previous 8 weeks
结局指标
主要结局
The complete clearance rate of lesions at 3 months, defined as the complete clinical disappearance of the treated lesion.
The complete clearance rate of lesions at 3 months, defined as the complete clinical disappearance of the treated lesion.
次要结局
- Reduction in the AKASI index: analyzed using an independent samples Student’s t-test or the Mann–Whitney U test depending on distribution.
- Recurrence or persistence at 6–12 months: analyzed using χ²/Fisher’s exact test.
- ncidence of new actinic keratoses (AK) or non-melanoma skin cancer (NMSC): comparison of proportions between groups.
研究者
Dra. Elena González Guerra
Scientific
Dra. Elena González Guerra
研究点 (3)
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