ALA-PDT Versus Vehicle PDT for Treatment of AK and Reduction of New NMSC in Solid Organ Transplant Recipients
A Randomized, Evaluator-Blinded, Parallel Group Comparison of PDT With Levulan Topical Solution + Blue Light vs Levulan Topical Solution Vehicle + Blue Light for the Treatment of AK and Reduction of New NMSC in Organ Transplant Recipients
研究概览
详细说明
This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel group study of photodynamic therapy in organ transplant recipient subjects for treatment of AK and the reduction of new NMSC.
Subjects will be randomized to one of the following two treatment groups (1:1) to receive topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug) or the Kerastick® containing vehicle ingredients only (VEH).
- Group 1 will have ALA applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to BLUE light treatment for 16 minutes 40 seconds
- Group 2 will have VEH applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to BLUE light treatment for 16 minutes 40 seconds
Treatment Area (scalp or both forearms) must have had at least 2 NMSC in the past 12 months, and must include a continuous 25 cm2 Target Area containing a minimum of 3 AKs, to be eligible for treatment
Each subject may receive up to nine treatments. The initial four (4) ALA-PDT/VEH-PDT treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks. Post-treatment follow-up visit will be scheduled to occur 4 weeks after the subject's final PDT.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
California
-
Irvine、California、美国、92697
- University of California, Irvine
-
San Francisco、California、美国、94115
- University of California, San Francisco
-
-
Florida
-
Miami、Florida、美国、33136
- University of Miami
-
-
Massachusetts
-
Boston、Massachusetts、美国、02111
- Tufts Medical Center
-
-
New York
-
New York、New York、美国、10029
- The Mount Sinai Medical Center
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19111
- Fox Chase Cancer Center
-
-
Tennessee
-
Nashville、Tennessee、美国、37204
- Vanderbilt University Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subject is male or non-pregnant female organ transplant (kidney, liver, pancreas, lungs, heart or combinations thereof) recipient outpatient 18 years of age or older. Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
- Subject has provided written and verbal informed consent.
- Subject has at least 3 actinic keratosis lesions in a continuous 25 cm2 Target Area within the selected anatomic treatment site (scalp or forearm).
- Subject has a history of a minimum of 2 NMSC on the treatment area of interest (scalp OR both forearms) in the past 12 months
- Subject is currently receiving standard active pharmacologic immunosuppression
- Subject is willing to comply with study instructions and return to the clinic for required visits.
- Subject has Fitzpatrick skin type I-IV.
Exclusion Criteria:
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
- Subject has any skin pathology or condition, in the investigator's opinion, that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
- Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Subject is currently enrolled in an investigational drug (including experimental immunosuppressive agents containing new chemical entities) or device study. Novel combinations of and alternative dosing regimens of approved immunosuppressive agents are allowed.
- Subject has received an investigational drug (including experimental immunosuppressive agents containing new chemical entities) or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline). Novel combinations of and alternative dosing regimens of approved immunosuppressive agents are allowed.
- Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
- Subject has active recurrent herpes simplex labialis infection in the treatment area with an outbreak within the last 12 months and will not be placed on antiviral prophylaxis as specified in the protocol.
Subject has used any of the following topical preparations on the selected Treatment Area (scalp OR both forearms):
- 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.
- 5-FU, cryotherapy, diclofenac, imiquimod or other treatments for AK within 2 weeks of initiation of treatment
- Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of the initiation of treatment.
- Microdermabrasion, laser ablative treatments, ALA-PDT or chemical peels within 8 weeks of the initiation of treatment.
- Two or more ALA PDT treatments in the past 6 months
- Subject has used systemic retinoid therapy within 6 months of the initiation of treatment.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:1
Topical Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA) will be applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to blue light treatment for 16 minutes and 40 seconds.
|
20% aminolevulinic acid HCL (ALA) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light.
Up to nine (9) ALA-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.
其他名称:
|
安慰剂比较:2
Kerastick containing vehicle ingredients only (VEH) will be applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to blue light treatment for 16 minutes 40 seconds.
|
Vehicle ingredients only (VEH) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light.
Up to nine (9) VEH-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Number of Skin Cancers within the Treatment Area
大体时间:entire study
|
entire study
|
AK Lesions Counts/Surface Area
大体时间:Visits 1,3,5,7,9,11,13,15,17,19
|
Visits 1,3,5,7,9,11,13,15,17,19
|
Investigator Global Assessment
大体时间:Visits 1,3,5,7,9,11,13,15,17,19
|
Visits 1,3,5,7,9,11,13,15,17,19
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Subject Acceptability of Treatment
大体时间:End of Study
|
End of Study
|
Tolerability Parameters
大体时间:Each Visit
|
Each Visit
|
合作者和调查者
调查人员
- 研究主任:Stuart L Marcus, MD, PhD、Sponsor GmbH
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Aminolevulinic Acid的临床试验
-
University College, LondonImperial College London; Cancer Research UK; National Cancer Imaging Translational Accelerator招聘中
-
University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)招聘中
-
Gladwin, Mark, MDNational Heart, Lung, and Blood Institute (NHLBI); Complexa, Inc.终止
-
Critical Outcome Technologies Inc.M.D. Anderson Cancer Center; Northwestern Memorial Hospital未知宫颈癌 | 头颈癌 | 大肠癌 | 胰腺癌 | 卵巢癌 | 输卵管癌 | 肺癌 | 子宫内膜癌 | 腹膜癌 | HNSCC美国