Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of clearance of actinic keratoses
研究概览
简要总结
To provide a treatment of both actinic keratoses and photodamage within one treatment.
详细描述
To demonstrate that treatment of actinic keratoses and photodamage with a combination of Ameluz and Broad Band Light (BBL) will lead to an improvement in facial precancerous change and signs of photodamage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18yrs of age
- •Willingness to participate in all required study activities and visits
- •Willingness to sign the informed consent form
- •Visible and palpable signs of diffuse actinic damage and actinic keratoses of mild to moderate severity located on the face
- •Significant signs of photoaging, evaluated by investigator, that include any or all the following:
- •Dyspigmentation
- •Solar lentigines
- •Telangiectasias
- •Diffuse erythema
- •Roughness and other textural changes
- •Fine lines
- •Actinic bronzing
排除标准
- •Subject who is unable and unwilling to provide consent for study schedule and procedures
- •Subject who is pregnant or trying to become pregnant during the study
- •Subjects using any topical treatment on their AKs; must stop at least one month prior
- •Subjects currently undergoing cancer treatment with medical or radiation therapy
- •Subjects with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
- •Subjects with history of a photosensitivity disease, such as porphyria cutanea tarda
研究组 & 干预措施
Two PDT treatments
Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.
干预措施: Ameluz (Drug)
Two PDT treatments
Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.
干预措施: Sciton HEROic (Device)
结局指标
主要结局
Percentage of clearance of actinic keratoses
时间窗: 2 months
Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face.
Cosmetic outcomes
时间窗: 2 months
Cosmetic outcomes in photoaging of the face evaluated by Subject and Investigator Global Aesthetic Improvement Scale (GAIS) at 1 and 2 months post last PDT. Scale: Very Satisfied (better than expected), Satisfied (as expected), Unsatisfied (worse than expected)
次要结局
- Percentage of clearance of actinic keratoses(2 months)
- Cosmetic outcomes(2 months)
研究者
Sherrif Ibrahim
Principal Investigator
Rochester Dermatologic Surgery