NCT01458587已完成2 期
A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
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
- 70
- 试验地点
- 3
- 主要终点
- Lesion Clearance Rate
研究概览
简要总结
The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.
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
- •At least 4 Grade 1/2 AKs on each upper extremity
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
- •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)
- •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
ALA
Experimental
干预措施: Aminolevulinic Acid PDT (ALA) (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle PDT (VEH) (Drug)
结局指标
主要结局
Lesion Clearance Rate
时间窗: Week 12
Clearance rate for all lesions
次要结局
- Lesion Clearance Rate(Week 8)
- Complete Clearance Rate(Week 12)
- Partial Clearance Rate(Baseline and Week 12)
- Subject Satisfaction Score(Week 12)
- Hyperpigmentation at Baseline(Baseline)
- Hyperpigmentation at Visit 3(2 weeks after PDT #1)
- Hyperpigmentation at Visit 4(8 weeks after PDT #1)
- Hyperpigmentation at Visit 5(12 weeks after PDT #1)
- Hypopigmentation at Baseline(Baseline)
- Hypopigmentation at Visit 3(2 Weeks after PDT #1)
- Hypopigmentation at Visit 4(8 Weeks after PDT #1)
- Hypopigmentation at Visit 5(12 Weeks after PDT #1)
- Erythema at Baseline(Baseline)
- Erythema Post-Light Treatment(5 Minutes after PDT #1)
- Erythema at Visit 3(2 Weeks after PDT #1)
- Erythema at Visit 4(8 Weeks after PDT #1)
- Erythema at Visit 5(12 Weeks after PDT #1)
- Edema at Baseline(Baseline)
- Edema Post-Light Treatment(5 Minutes after PDT #1)
- Edema at Visit 3(2 Weeks after PDT #1)
- Edema at Visit 4(8 Weeks after PDT #1)
- Edema at Visit 5(12 Weeks after PDT #1)
- Stinging/Burning at Baseline(Baseline)
- Stinging/Burning During Light Treatment(During PDT #1)
- Stinging/Burning Post Light Treatment(5 minutes after PDT #1)
- Stinging/Burning at Visit 3(2 Weeks after PDT #1)
- Stinging/Burning at Visit 4(8 Weeks after PDT #1)
- Stinging/Burning at Visit 5(12 Weeks after PDT #1)
- Scaling and Dryness at Baseline(Baseline)
- Scaling and Dryness at Visit 3(2 Weeks Post PDT #1)
- Scaling and Dryness at Visit 4(8 Weeks Post PDT #1)
- Scaling and Dryness at Visit 5(12 Weeks Post PDT #1)
- OOZING/VESICULATION/CRUSTING at Baseline(Baseline)
- OOZING/VESICULATION/CRUSTING at Visit 3(Week 2 after PDT #1)
- OOZING/VESICULATION/CRUSTING at Visit 4(8 Weeks after PDT #1)
- OOZING/VESICULATION/CRUSTING at Visit 5(12 Weeks after PDT #1)
研究者
研究点 (3)
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