Evaluating Photodynamic Therapy Used to Treat Cutaneous Squamous Cell Carcinoma in Situ (isSCC) on the Face, Upper Extremities & Trunk.
An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) With Blue Light Model 4170E in the Treatment of Cutaneous Squamous Cell Carcinoma in Situ (isSCC) Located on the Face, Upper Extremities and Trunk.
The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, upper extremities and trunk, using a light sensitive cream used in combination with a light source.
The main questions this trial aims to answer are:
- to confirm using laboratory testing, how much of the affected skin cancer section the treatment was able to remove, and;
- seeing how many participants had no remaining affected skin cancer sections after treatment.
Participants who qualify will be asked to complete 12 visits in total and will receive a total of two treatments, after voluntarily consent has been given.
研究概览
地位
详细说明
In the study, participants will be asked to complete the following:
- Provide basic personal information (including date of birth, gender, race and ethnicity)
- Provide their medical/ surgical history and perform a medical exam (including but not limited to physical exam, skin type, vital signs, height, weight and urine pregnancy test collection)
- Follow study rules such as avoiding certain medications and treatments
- Allow photographs of the area of skin cancer being treated on the face or upper extremities/ trunk.
- Provide information on any medications, treatments or reactions that started after the study began
- Allow two treatments on the skin cancer area of the face upper extremities/ trunk using a light sensitive cream used in combination with a light source
- Allow clinical documentation of the treatment, such as how well the treatment was tolerated, any skin reaction or side effects
- Allow surgery to remove the skin cancer area from the face or upper extremities/ trunk for Laboratory testing
To qualify for this trial, participants must:
- be an adult (18 years of age or older)
- give voluntary written consent
- have a recently diagnosed (less than six months from first visit) skin cancer area on the face or upper extremities/ trunk that meets surgery size requirements
- be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
- (if female) not be pregnant before and during the study and agree to use acceptable forms of birth control
- confirm they are not sensitive to any of the study treatment ingredients
All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing.
All photographs of the treatment area collected during the study will be used as study data.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Clinical Coordinator
- 电话号码：305-933-6716
- 邮箱：info@centerforclinicalandcosmeticresearch.com
学习地点
-
-
Florida
-
Aventura、Florida、美国、33180
- 招聘中
- Center for Clinical and Cosmetic Research
-
接触：
- Clinical Coordinator
- 电话号码：305-933-6716
- 邮箱：info@centerforclinicalandcosmeticresearch.com
-
首席研究员：
- Mark S. Nestor, MD, PhD
-
-
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:
- Must be an adult (18 years of age or older).
- Voluntary written consent required.
- Must have a recently diagnosed (no more than six months from first study visit) facial or trunk/ upper extremities isSCC (Squamous Cell Carcinoma in situ) lesion that meets surgery excision size requirements.
- Cannot have other dermatological disease in the isSCC target area.
- Must be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas.
- If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control.
Exclusion Criteria:
- Sensitive to any of the study treatment ingredients.
- Pregnant or lactating.
- Medical laboratory evidence of other non-isSCC tumor in the target lesion biopsy specimen.
- History of recurrence in the target isSCC lesion.
- Medical laboratory evidence of certain growth patterns in the target lesion biopsy specimen.
- Chronic medical condition that in the Investigators opinion will interfere in the trial or affect participant safety.
- History of abnormal heart muscles.
- Currently participating in a research study or have been treated with an investigational product within 30 days from first study 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：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Facial isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)
8 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.
其他名称：
|
|
实验性的：Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)
8 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.
其他名称：
|
|
实验性的：Facial isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)
7 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 8 minutes and 20 seconds to deliver the total desired light dose to the isSCC lesion.
其他名称：
|
|
实验性的：Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)
7 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 8 minutes and 20 seconds to deliver the total desired light dose to the isSCC lesion.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants with Histological Clearance of treated isSCC lesion
大体时间：Up to 63 days after treatment 2.
|
Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports |
Up to 63 days after treatment 2.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants with clinical clearance of treated isSCC lesion
大体时间：Up to 63 days after treatment 2.
|
Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site. |
Up to 63 days after treatment 2.
|
|
Local Skin Response Scale
大体时间：Up to 63 days after treatment 2
|
Observations and changes noted in the aesthetic appearance of the treated isSCC lesion site. |
Up to 63 days after treatment 2
|
合作者和调查者
调查人员
- 首席研究员：Mark S Nestor, MD, PhD、Center for Clinical and Cosmetic Research
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CCCR 02-2024
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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