A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT OF ACTINIC KERATOSES ON THE FACE OR SCALP
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 7
- 主要终点
- Complete Clearance Rate
研究概览
简要总结
The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp
排除标准
- •Pregnancy
- •grade 3 and/or atypical >1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the Treatment Area
- •history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- •lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- •skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- •Subject is immunosuppressed
- •unsuccessful outcome from previous ALA-PDT therapy
- •currently enrolled in an investigational drug or device study
- •has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
- •known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
- •has active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area
- •use of the following topical preparations on the extremity to be treated:
- •Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
- •Curettage or Cryotherapy within 2 weeks of initiation of treatment
- •Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
- •Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
- •use of systemic retinoid therapy within 6 months of initiation of treatment.
研究组 & 干预措施
ALA 20 mW
ALA + IBL 10J at 20 mW (8min 20 sec)
干预措施: ALA (Drug)
ALA 20 mW
ALA + IBL 10J at 20 mW (8min 20 sec)
干预措施: IBL 20 mW (Device)
ALA 10 mW
ALA + IBL 10J at 10 mW (16 min 40 sec)
干预措施: ALA (Drug)
ALA 10 mW
ALA + IBL 10J at 10 mW (16 min 40 sec)
干预措施: IBL 10 mW (Device)
Vehicle
Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group
干预措施: Vehicle (Drug)
Vehicle
Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group
干预措施: IBL 20 mW (Device)
Vehicle
Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group
干预措施: IBL 10 mW (Device)
结局指标
主要结局
Complete Clearance Rate
时间窗: Week 12
proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
次要结局
- Baseline AK Clearance Rate(Baseline and Week 4)
- Complete Clearance Rate(Week 4)