A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Intradermally Administered AIV001 in Subjects With Papulopustular Rosacea
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of Adverse Events
研究概览
简要总结
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
详细描述
This is primarily a safety study to evaluate the safety of AIV001 when administered to subjects with rosacea. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study medication will be administered by the Treating Investigator. Safety and efficacy measures will be evaluated by the masked Evaluating 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
- •Healthy male and/or female subjects between the ages of 18 and 65 year with rosacea, 10 to 30 papules and pustules (at least 5 lesions within the treatment area on each facial side), and < 2 nodules
- •Presence of moderate to severe persistent erythema
- •Total body weight >45 kg
排除标准
- •Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea
- •Extremely dark skin type that would confound the digital analysis of erythema (eg, Fitzpatrick Skin Type 5 or 6)
- •Excessive facial hair (eg, beards, sideburns, moustaches, etc.), birthmarks, or tattoos that would interfere with diagnosis or assessment of rosacea
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to start of treatment.
- •Hypersensitivity or allergy to axitinib or any other component of the study treatment
- •Use within 6 months prior to baseline and during the study of oral retinoids (eg, Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- •Use within 6 weeks prior to baseline and during the study of vasodilators or α-adrenergic receptor-blocking agents.
- •Use within 1 month prior to baseline and during the study of 1) topical retinoids to the face, 2) systemic antibiotics know to have an impact on the severity of facial rosacea (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim), 3) systemic corticosteroids, or 4) facial light-based therapies
研究组 & 干预措施
Cohort 4 - 1%
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
干预措施: AIV001 (Drug)
Cohort 1 - vehicle
Subjects randomized to vehicle will receive vehicle administration to the target area.
干预措施: Vehicle (Drug)
Cohort 1 - 0.033%
Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area.
干预措施: AIV001 (Drug)
Cohort 2 - vehicle
Subjects randomized to vehicle will receive vehicle administration to the target area.
干预措施: Vehicle (Drug)
Cohort 2 - 0.1%
Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area.
干预措施: AIV001 (Drug)
Cohort 3 - vehicle
Subjects randomized to vehicle will receive vehicle administration to the target area.
干预措施: Vehicle (Drug)
Cohort 3 - 0.3%
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
干预措施: AIV001 (Drug)
Cohort 4 - vehicle
Subjects randomized to vehicle will receive vehicle administration to the target area.
干预措施: Vehicle (Drug)
结局指标
主要结局
Rate of Adverse Events
时间窗: Day 1 through Day 84
The occurrence of adverse events will be collected and reported using MedDRA to code. Description, start and end dates, and severity will be recorded.
次要结局
- Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale(Day 1 through Day 84)
- Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts(Day 1 through 84)
- Evaluation of Erythema and Topography using Standardized Photography(Day 1 through 84)