A Phase 2 Study of the Effect of Microneedle Lesion Preparation, Incubation Time and Light Power Density on Photodynamic Therapy With Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% + Blue Light for the Field Treatment of Actinic Keratoses on the Face
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 8
- 主要终点
- Complete Clearance Rate
研究概览
简要总结
The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.
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 eight AKs on the face
排除标准
- •Pregnancy
- •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
- •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 an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
- •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
- •Curettage or Cryotherapy within 2 weeks of initiation of treatment
- •Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
- •Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5 fluorouracil, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
- •use of systemic retinoid therapy within 6 months
研究组 & 干预措施
ALA 25 min 10 Milliwatts (mW)
ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: ALA (Drug)
ALA 25 min 10 Milliwatts (mW)
ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: IBL 10 mW (Device)
MN + ALA 25 min 20 mW
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: Microneedle lesion preparation (Procedure)
MN + ALA 25 min 10 mW
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: ALA (Drug)
MN + ALA 25 min 10 mW
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: IBL 10 mW (Device)
MN + ALA 25 min 10 mW
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: Microneedle lesion preparation (Procedure)
ALA 25 min 20 mW
ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: ALA (Drug)
ALA 25 min 20 mW
ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: IBL 20 mW (Device)
MN + ALA 25 min 20 mW
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: ALA (Drug)
MN + ALA 25 min 20 mW
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: IBL 20 mW (Device)
ALA 60 min 10 mW
ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: ALA (Drug)
ALA 60 min 10 mW
ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: IBL 10 mW (Device)
MN + ALA 60 min 10 mW
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: ALA (Drug)
MN + ALA 60 min 10 mW
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: IBL 10 mW (Device)
MN + ALA 60 min 10 mW
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: Microneedle lesion preparation (Procedure)
ALA 60 min 20 mW
ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: ALA (Drug)
ALA 60 min 20 mW
ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: IBL 20 mW (Device)
MN + ALA 60 min 20 mW
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: ALA (Drug)
MN + ALA 60 min 20 mW
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: Microneedle lesion preparation (Procedure)
MN + ALA 60 min 20 mW
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
干预措施: IBL 20 mW (Device)
VEH
Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: Topical Solution Vehicle (Drug)
VEH
Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: IBL 10 mW (Device)
MN + VEH
Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: Topical Solution Vehicle (Drug)
MN + VEH
Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: IBL 10 mW (Device)
MN + VEH
Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
干预措施: Microneedle lesion preparation (Procedure)
结局指标
主要结局
Complete Clearance Rate
时间窗: Week 12
Number of AK Fields with 0 lesions
次要结局
- Complete Clearance Rate(Week 8)
- Percent Change(Baseline and Week 12)
- Subject Satisfaction Score(Week 12)
- Baseline AKCR(Baseline and Week 12)