Safety and Efficacy Study of Topical Methyaminlevulinate (MAL) in Subjects With Facial Acne
2009年1月29日 更新者：Photocure
A Study of Safety and Efficacy of Topical Methylaminolevulinate 80mg/g With and Without Occlusion Followed by Red Light Exposure in Subjects With Facial Acne
A study of safety and efficacy of topical methyaminlevulinate 80mg/g with and without occlusion followed by red light exposure in subjects with facial acne.
研究概览
详细说明
Photocure ASA has developed a cream formulation containing methyl aminolevulinate (MAL), an ester of ALA. There is extensive experience with the safety of MAL-PDT in humans.
This study will assess safety and efficacy of four treatments with methylaminolevulinate (MAL) at 80 mg/g performed with and without occlusion and followed by red light exposure 90 minutes later in subjects with facial acne vulgaris. Subjects will be randomized to one of two groups of 20 subjects: Group 1 will receive 25 J/cm2 of red light (45 mW/cm2) and group 2 will receive 37 J/cm2 of red light (90 mW/cm2). For each subject one side of the face will be randomized to receive MAL for 90 minutes without occlusion and the other side of the face will receive MAL for 90 minutes with occlusion.
研究类型
介入性
注册 (实际的)
44
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Quebec
-
Laval、Quebec、加拿大、H7S 2C6
- Innovaderm Research Inc
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Montreal、Quebec、加拿大、H2K 4L5
- Innovaderm Research Inc.
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subject willing to use an adequate contraceptive method or is surgically sterile, post menopausal, abstinent or with a same-sex partner. Adequate means of contraception include; IUD in use 30 days prior to day 0, barrier methods and spermicide in use atleast 14 days prior to day 0 or oral contraceptive in use for at least 6 months prior to day 0
- Age 18 or older
- Capable of giving informed consent
- Diagnosis of acne vulgaris on the face with at least 10 inflammatory lesions on both sides of the face at screening and day 0
- Global acne severity assessment score ≥ 3 at the screening and day 0 visit.
Exclusion Criteria:
- Allergy to methylaminolevulinate or any component of the vehicle
- Acne fulminans or conglobata on the face
- Clinical significant sensitivity to visible light, porphyria or porphyrin sensitivity
- Use of any topical treatment for acne on the face within the previous 2 weeks before day 0
- Any use of systemic antibiotics within 1 month prior to day 0 or use of isotretinoin within 1 year prior to Day 0
- Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within 4 weeks of Day 0
- Use of any investigational drug within 4 weeks of Day 0
- Alcoholism or drug abuse in the past year
- Any unstable or serious medical condition at the discretion of the investigator
- Current pregnancy or lactation
- Use of hormonal contraceptives solely for control of acne
- Current use of oral contraceptives (unless subject is on a stable dose e.i. at least six months of treatment prior Day 0), testosterone or any other systemic hormonal treatment
- Any serious dermatological disorder, including malignancies that would either put the subject at risk or interfere with efficacy or safety evaluations
- Fitzpatrick phototype V or VI (inadequate penetration of red light in dark skin subjects)
- Subjects with extensive facial hair (e.g. beard) that would either impair red light exposure or interfere with lesion evaluation.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：25 J/cm2, with occlusion on right side
Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g).
Occlusion will be applied to one half of the face.
After an incubation time of 90 minutes both sides of the face will be exposed to either 25 J/cm2 of red light starting with the occluded side first.
|
80 mg/g cream one administration with incubation for 90 minutes
|
|
有源比较器：37 J/cm2, with occlusion on right side
Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g).
Occlusion will be applied to one half of the face.
After an incubation time of 90 minutes both sides of the face will be exposed to 37 J/cm2 of red light starting with the occluded side first.
|
80 mg/g cream one administration with incubation for 90 minutes
|
|
有源比较器：25 J/cm2 , with occlusion on left side
Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g).
Occlusion will be applied to one half of the face.
After an incubation time of 90 minutes both sides of the face will be exposed to either 25 J/cm2 of red light starting with the occluded side first.
|
80 mg/g cream one administration with incubation for 90 minutes
|
|
有源比较器：37 J/cm2 , with occlusion on left side
Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g).
Occlusion will be applied to one half of the face.
After an incubation time of 90 minutes both sides of the face will be exposed to 37 J/cm2 of red light starting with the occluded side first.
|
80 mg/g cream one administration with incubation for 90 minutes
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To compare the number of inflammatory acne lesions according to time on the side with occlusion and the side without occlusion for subjects with facial acne vulgaris exposed to 25 J/cm2 and 37 J/cm2 of red light.
大体时间：4 and 12 weeks after last PDT session.
|
4 and 12 weeks after last PDT session.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Exposed to 25 J/cm2 and 37 J/cm2 of red light and with and withut occlusion :-Compare number of non-inflammatory acne lesions. -Safety assesment of MAL-PDT. -Evaluate PAP photobleaching.
大体时间：At each treatment visit and 2 and 7 days after first PDT treatment visit.
|
At each treatment visit and 2 and 7 days after first PDT treatment visit.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Robert Bissonnette, MD MSC FRCPC、Innovaderm Research Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年7月1日
初级完成 (实际的)
2008年7月1日
研究完成 (实际的)
2008年7月1日
研究注册日期
首次提交
2009年1月29日
首先提交符合 QC 标准的
2009年1月29日
首次发布 (估计)
2009年1月30日
研究记录更新
最后更新发布 (估计)
2009年1月30日
上次提交的符合 QC 标准的更新
2009年1月29日
最后验证
2009年1月1日
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.