A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- AUCt
研究概览
简要总结
The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 Grade 1/2 AKs on one upper extremity AND
- •At least 12 Grade 1/2 AKs on the OTHER upper extremity
排除标准
- •Pregnancy
- •history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- •lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- •Body Mass Index (BMI) > 32.0 kg/m2
- •skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- •significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
- •tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
- •a history of lead poisoning or a history of a significant exposure to lead
- •tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
- •positive drug screen at Screening
- •Screening safety labs are clinically significant in the opinion of the investigator
- •major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study
- •Subject is immunosuppressed
- •currently enrolled in an investigational drug or device study
- •has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline)
- •known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
- •use of the following topical preparations on the extremities to be treated:
- •Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment
- •Cryotherapy within 2 weeks of initiation of treatment
- •Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment
- •Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment
- •use of systemic retinoid therapy within 6 months of initiation of treatment
研究组 & 干预措施
ALA
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
干预措施: Aminolevulinic Acid (ALA) (Drug)
ALA
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
干预措施: BLU-U (Device)
结局指标
主要结局
AUCt
时间窗: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose
AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration
The Terminal Exponential Half-life (T1/2,z) for ALA
时间窗: 2 days
The terminal slope was calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.
AUCBL for PpIX
时间窗: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose
The area under the concentration time-curve assuming the baseline observed plasma concentration existed from time 0 to tlast.
Time at Which Cmax is Attained (Tmax) for ALA
时间窗: 2 days
Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.
Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX
时间窗: 2 days
Maximum baseline corrected plasma concentration (Cmax) for PpIX over the 48 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.
Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA
时间窗: 2 days
Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.
Time at Which Cmax is Attained (Tmax) for PpIX
时间窗: 2 days
Time of the maximum baseline corrected plasma concentration for PpIX measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.
AUCt for PpIX
时间窗: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose
The area under the observed plasma concentration time-curve from time 0 to the last quantifiable plasma concentration.
AUCt/AUCBL for PpIX
时间窗: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose
The ratio of AUCt to AUCBL for PpIX
次要结局
- Edema(Week 4)
- Hyperpigmentation(Week 4)
- Hypopigmentation(Week 4)
- Erythema(Week 4)
- OOZING/VESICULATION/CRUSTING(Week 4)
- Scaling and Dryness(Week 4)
- Scaling and Dryness at Visit 4(24 hours after PDT)
- Stinging/Burning(Week 4)