A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Global photodamage improvement
研究概览
简要总结
Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale)
- •Patients willing to participate
- •Signed informed consent
排除标准
- •Pregnant or nursing females
- •Subjects with any photosensitizing disorder
- •Any active infectious skin disorder
- •History of herpes simplex in the face
- •Subjects with less than 6 months of any previous rejuvenation interfering treatments
- •History of systemic isotretinoin in the last year
- •Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments
- •History of hypersensitivity reactions
- •Activities with high sun exposure during 48 hours after treatment
- •Clinical suspicion of any systemic or local malignancy
研究组 & 干预措施
Methyl Aminolevulinate (MAL)
1 gram of Topical Methyl Aminolevulinate (MAL) applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)
干预措施: Methyl Aminolevulinate (MAL) (Drug)
Placebo
1 gram of placebo cream applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)
干预措施: Placebo (Drug)
结局指标
主要结局
Global photodamage improvement
时间窗: 1 month after third session
The primary outcome is global photodamage improvement 1 month after the third daylight PDT session, according to Dover´s photodamage scale.
次要结局
- Therapy tolerance(1 week after sessions 1,2 and 3)
- Pain measurement(After 2 hours of sun exposure in each session)
- Sun irradiance and illuminance quantification(During the 2 hours of each session)
- Specific Photodamage score(1 month after the third session)
- Adverse events(From recruitment until 1 month after the third session)
- Quality of life assessment (Skindex-29 Instrument)(Basal and 1 month after the third session)