NCT01475955已完成2 期
A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 13
- 主要终点
- Complete Clearance Rate
研究概览
简要总结
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.
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
- •6-20 Grade 1/2 AKs on the face or scalp
- •a history of AK therapy within the treatment area at least twice in the two years prior to study entry
排除标准
- •Pregnancy
- •Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area
- •lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- •plans to be exposed to artificial tanning devices or excessive sunlight during the trial
- •Subject is immunosuppressed
- •unsuccessful outcome from previous ALA-PDT therapy
- •history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- •skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- •skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- •any condition which would make it unsafe for the subject to participate in this research study
- •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)
- •Subject has;
- •an active herpes simplex infection OR
- •a history of 2 or more outbreaks within the past 12 months, in the Treatment Area
- •use of the following topical preparations on the extremities 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.
- •Cryotherapy within 2 weeks of initiation of treatment
- •Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment.
- •Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
- •Two or more ALA PDT treatments in the past 6 months
- •use of systemic retinoid therapy within 6 months of initiation of treatment.
研究组 & 干预措施
Broad Area ALA 1-hour incubation
Experimental
Broad Area ALA 1-hour incubation
干预措施: Broad Area ALA 1-hour incubation (Drug)
Broad Area ALA 1-hour incubation
Experimental
Broad Area ALA 1-hour incubation
干预措施: Blue Light Treatment (Device)
Broad Area ALA 2-hour incubation
Experimental
Broad Area ALA 2-hour incubation
干预措施: Broad Area ALA 2 hour incubation (Drug)
Broad Area ALA 2-hour incubation
Experimental
Broad Area ALA 2-hour incubation
干预措施: Blue Light Treatment (Device)
Broad Area ALA 3-hour incubation
Experimental
Broad Area ALA 3-hour incubation
干预措施: broad area ALA 3-hour incubation (Drug)
Broad Area ALA 3-hour incubation
Experimental
Broad Area ALA 3-hour incubation
干预措施: Blue Light Treatment (Device)
Spot ALA 2-hour incubation
Experimental
Spot ALA 2-hour incubation
干预措施: Spot ALA 2 hour incubation (Drug)
Spot ALA 2-hour incubation
Experimental
Spot ALA 2-hour incubation
干预措施: Blue Light Treatment (Device)
Vehicle PDT
Placebo Comparator
VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
干预措施: Vehicle PDT (Drug)
Vehicle PDT
Placebo Comparator
VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
干预措施: Blue Light Treatment (Device)
结局指标
主要结局
Complete Clearance Rate
时间窗: Week 12
The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
次要结局
- Hyperpigmentation at Visit 7(Week 24)
- Hypopigmentation at Baseline(Baseline)
- Hypopigmentation at Visit 2(24-48 Hours after PDT #1)
- Hypopigmentation at Visit 3(Week 2)
- Hypopigmentation at Visit 5(Week 8)
- Hypopigmentation at Visit 6(Week 12)
- Erythema at Visit 3(Week 2)
- Erythema at Visit 4(Week 4)
- Erythema at Visit 5 (Pre-drug)(Week 8 pre-drug)
- Erythema at Visit 5 (Post-light)(Week 8 5 minutes post light treatment)
- Complete Clearance Rate(Week 24)
- Partial Clearance Rate(Baseline Week 24)
- AK Clearance Rate(Baseline, Week 24)
- Subject Satisfaction Score(Week 24)
- Hyperpigmentation at Baseline(Baseline)
- Hyperpigmentation at Visit 2(24-48 Hours after PDT #1)
- Hyperpigmentation at Visit 3(Week 2)
- Hyperpigmentation at Visit 4(Week 4)
- Hyperpigmentation at Visit 5(Week 8)
- Hyperpigmentation at Visit 6(Week 12)
- Hypopigmentation at Visit 7(Week 24)
- Erythema at Baseline(Baseline)
- Hypopigmentation at Visit 4(Week 4)
- Erythema at Visit 6(Week 12)
- Erythema at Visit 7(Week 24)
- Edema Post PDT #2(5 minutes post PDT #2)
- Erythema Post-Light Treatment(5 minutes after PDT #1)
- Edema at Week 12(Week 12)
- Edema at Week 24(Week 24)
- Stinging/Burning at Baseline(Baseline)
- Stinging/Burning During Light Treatment(During PDT #1 (most intense sensation))
- Stinging/Burning Post Light-Treatment(5 minutes post PDT #1)
- Stinging/Burning at Visit 2(24-48 hours post PDT #1)
- Stinging/Burning at Visit 3(Week 2)
- Stinging/Burning at Visit 4(Week 4)
- Stinging/Burning at Visit 5 (Pre-drug)(Week 8 prior to drug)
- Stinging/Burning at Visit 5 During PDT#2(during PDT #2)
- Stinging/Burning at Visit 5 Post PDT#2(5 minutes post PDT #2)
- Erythema at Visit 2(24-48 hours after PDT #1)
- Stinging/Burning at Visit 6(Week 12)
- Stinging/Burning at Visit 7(Week 24)
- Scaling and Dryness at Baseline(Baseline)
- Scaling and Dryness at Visit 2(24-48 hours after PDT #1)
- Scaling and Dryness at Visit 3(Week 2)
- Scaling and Dryness at Visit 4(Week 4)
- Scaling and Dryness at Visit 5(Week 8)
- Edema at Baseline(Baseline)
- Edema Post-Light Treatment(5 minutes after PDT #1)
- Edema at Visit 2(24-48 hours post PDT#1)
- Edema at Visit 3(Week 2)
- Edema at Visit 4(Week 4)
- Edema at Visit 5 (Pre-drug)(Week 8 pre-drug)
- Scaling and Dryness at Visit 6(Week 12)
- Scaling and Dryness at Visit 7(Week 24)
- Oozing/Vesiculation/Crusting at Baseline(Baseline)
- Oozing/Vesiculation/Crusting at Visit 2(24-48 hours after PDT #1)
- Oozing/Vesiculation/Crusting at Visit 3(Week 2)
- Oozing/Vesiculation/Crusting at Visit 4(Week 4)
- Oozing/Vesiculation/Crusting at Visit 5(Week 8)
- Oozing/Vesiculation/Crusting at Visit 6(Week 12)
- Oozing/Vesiculation/Crusting at Visit 7(Week 24)
研究者
研究点 (13)
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