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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low Dose
干预措施: AZX100 Drug Product (Drug)
High Dose
干预措施: AZX100 Drug Product (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
时间窗: 12 Months
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.
次要结局
- Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters(12 Months)
- Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)(12 Months)
- Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)(12 months)