A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 8
- 主要终点
- Total Number of AKs in Treatment Area
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 keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.
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 AKs on the face
- •histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
- •at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years
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)
- •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
- •Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
- •Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), 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 X2
Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
干预措施: BLU-U (Device)
ALA X3
Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
干预措施: Aminolevulinic Acid (Drug)
ALA X3
Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
干预措施: BLU-U (Device)
ALA X3
Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
干预措施: Cryotherapy (Procedure)
VEH
Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.
干预措施: Topical Solution Vehicle (Drug)
VEH
Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.
干预措施: BLU-U (Device)
VEH
Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.
干预措施: Cryotherapy (Procedure)
ALA X2
Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
干预措施: Aminolevulinic Acid (Drug)
ALA X2
Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
干预措施: Cryotherapy (Procedure)
结局指标
主要结局
Total Number of AKs in Treatment Area
时间窗: Week 52
Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.
次要结局
- Proportion of Subjects With 0 AKs(Week 52)
- Subject Satisfaction Score(Week 52)
- Recurrence Rate(Week 52)
- Duration of Response(within 52 weeks after Baseline)