A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
2012年9月10日 更新者：Capstone Therapeutics
A Pilot Phase 2a Blinded, Placebo Controlled, Multicenter Parallel Group, Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloids
The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.
研究概览
研究类型
介入性
注册 (实际的)
59
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
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California
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Pasadena、California、美国、91105
- Lotus Clinical Research, Inc.
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19103
- Paddington Testing Company, Inc.
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Texas
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Austin、Texas、美国、78759
- Dermresearch, Inc.
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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 至 65年 (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:
- Keloid scar located below the neck between 1 and 3 cm long and less than 1 cm at its widest point
- Willing to undergo keloid scar excision surgery
- Healthy adult male or non-pregnant female
- Non-diabetic
- Body Mass Index in the range of 18-35
- No clinically significant abnormal values on a full blood safety screen
- Non-smoker and non-nicotine user for the previous six months
Exclusion Criteria:
- History or clinical evidence of acute or chronic disease
- History of cancer within the last 5 years, except for surgically removed cancers of the skin that are not near the keloid area
- History of anaphylactic shock or anaphylactoid (hypersensitivity) reaction
- Allergy to local anesthesia, including lidocaine and epinephrine
- Dermatologic disorders, except for folliculitis and acne
- On therapy with steroids
- On therapy with a drug that would affect collagen synthesis
- Positive urine test for nicotine or drugs of abuse
- Positive blood test for HIV 1 or 2, hepatitis B or hepatitis C
- Positive blood test for anti-AZX100 antibodies
- Participation in another study within 60 days prior to enrollment
- Blood donation within 7 days before dosing with study drug
- Plasma donation within 3 days before dosing with study drug
- Tattoo within approximately 3 cm of the keloid scar that will be removed
- Apply any lotion or cream on or near the keloid scar that will be removed within 14 days before dosing with study drug
- Use of a tanning bed or tanning light within the 3 months before enrollment
- Intend to use any scar improving product during of the study (1 year)
- History of drug addiction or excessive use of alcohol
- Previous drug treatment of the keloid scar within the last 3 years, or have had any laser, irradiation, or surgical treatment of the keloid scar that will be removed
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：预防
- 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 |
|---|---|
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安慰剂比较：安慰剂
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受试者在瘢痕疙瘩去除部位每线性厘米皮内注射安慰剂（0.9% 盐水）。
第一剂在手术后 19-23 天给药，第二剂在手术后 40-44 天给药。
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实验性的：高剂量
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受试者在瘢痕疙瘩去除部位皮内注射每线性厘米 10 毫克的 AZX100（高剂量）。
第一剂在手术后 19-23 天给药，第二剂在手术后 40-44 天给药。
Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal.
The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
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实验性的：低剂量
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受试者在瘢痕疙瘩去除部位皮内注射每线性厘米 10 毫克的 AZX100（高剂量）。
第一剂在手术后 19-23 天给药，第二剂在手术后 40-44 天给药。
Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal.
The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
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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 |
|---|---|---|
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Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
大体时间：12 Months
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Efficacy was based on the difference between mean POSAS scores of placebo, 0.3 mg AZX100, and 1 mg AZX100 12 months after surgery.
This gave four comparisons to placebo: patient or observer and 0.3 mg and 1 mg AZX100.
PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful?
Is the scar itching?
Is the color of the scar different?
Is the scar more stiff?
Is the thickness of the scar different?
Is the scar irregular?
The possible minimum score was 6 and the maximum (worst) score was 60.
OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability.
The possible minimum score was 5 and the possible maximum (worst) score was 50.
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12 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters
大体时间：12 Months
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At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 mm, with 0 being normal skin and 100 being the worst scar imaginable.
The scars were presented in a scrambled order.
Efficacy was based on the difference between VAS scores of placebo and 0.3 mg AZX100, and placebo and 1 mg AZX100, for each of the two raters separately.
Data from the two raters was not combined.
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12 Months
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Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)
大体时间：12 Months
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This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to the maximum length, and minimum, maximum and mean elevation.
All elevation measurements were made relative to the interpolated smooth skin surface.
A value closest to zero was preferred, because zero was equal to the normal skin surface.
The minimum elevation value was calculated as the lowest point of the scar below the interpolated smoooth skin surface and was always a negative number.
A more negative number was worse, because it indicated a deeper measurement below the interpolated smooth skin surface.
The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface.
A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface.
The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.
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12 Months
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Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)
大体时间：12 months
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This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume and total volume.
All volume measurements were made relative to the interpolated smooth skin surface.
A value closer to zero was preferred, because zero was equal to the normal skin surface.
Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface.
Negative volume was calculated as the volume of the scar below the interpolated smooth skin surface, and was always a negative number.
Total volume was calculated as the sum of the positive volume and the absolute value of the negative volume.
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12 months
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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。
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
2009年5月1日
初级完成 (实际的)
2010年9月1日
研究完成 (实际的)
2010年9月1日
研究注册日期
首次提交
2009年4月30日
首先提交符合 QC 标准的
2009年4月30日
首次发布 (估计)
2009年5月4日
研究记录更新
最后更新发布 (估计)
2012年10月11日
上次提交的符合 QC 标准的更新
2012年9月10日
最后验证
2012年9月1日
更多信息
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