Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Face and (Bald) Scalp
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 10
- 主要终点
- Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area.
研究概览
简要总结
This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the face or bald scalp. Approximately 160 adult patients with 4-8 mild to moderate AK lesions will be randomized into four treatment arms based on two variables: type of treatment (active drug or vehicle) and incubation time. During the study, up to 2 PDT sessions may be administered depending on the clearance of lesions. The primary endpoint is complete clearance rate (CCR) at Week 12. Secondary endpoints include AK clearance rate (AKCR), partial clearance, change in total lesion count and area, recurrence rate, cosmetic response, and patient satisfaction. Safety assessments include adverse events, local skin reactions, vital signs, and lab tests.
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
The participant, investigator and outcomes assessor are blinded to treatment assignment, as both Levulan and Vehicle products look identical and cannot be differentiated from the application characteristics.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a male or non-pregnant female aged 18-85 years.
- •Patient must have 4-8 mild to moderate actinic keratosis (AK) lesions (Olsen grade 1 or 2) in a single treatment area (either face or bald scalp, not both), each ≤1 cm in diameter and spaced at least 1 cm apart. [The treatment area should be approximately 25 cm², excluding sensitive facial regions (eyes, lips, nostrils, ears, mouth)]
- •Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.
- •Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an efficacy evaluation.
- •Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile.
排除标准
- •Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.
- •Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.
- •History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.
- •Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
- •Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects.
- •Use of specific topical therapies (e.g., retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks prior to randomization.
- •Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization.
- •Recent use of hypericin or other phototoxic/photoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization.
- •Clinically significant or unstable illnesses, or history of alcohol/drug abuse in the past year.
- •Pregnancy/lactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.
研究组 & 干预措施
Levulan + Incubation time 1
Levulan application + Incubation time 1 + blue light application
干预措施: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% (Drug)
Levulan + Incubation time 1
Levulan application + Incubation time 1 + blue light application
干预措施: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E (Device)
Vehicle + Incubation time 1
Vehicle application + Incubation time 1 + blue light application
干预措施: Vehicle containing excipients only (VEH) without active ingredient (Other)
Vehicle + Incubation time 1
Vehicle application + Incubation time 1 + blue light application
干预措施: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E (Device)
Levulan + Incubation time 2
Levulan application + Incubation time 2 + blue light application
干预措施: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% (Drug)
Levulan + Incubation time 2
Levulan application + Incubation time 2 + blue light application
干预措施: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E (Device)
Vehicle + Incubation time 2
Vehicle application + Incubation time 2 + blue light application
干预措施: Vehicle containing excipients only (VEH) without active ingredient (Other)
Vehicle + Incubation time 2
Vehicle application + Incubation time 2 + blue light application
干预措施: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E (Device)
结局指标
主要结局
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area.
时间窗: Week 12
Complete clearance is defined as clearance of all AK lesions in the Treatment Area after PDT 1 or PDT 2, if re-treated; lesions should no longer be palpable nor visible to be declared as "cleared".
次要结局
- Percent change in total AK lesion area from Baseline to Weeks 8, 12, and 24.(Weeks 8, 12, and 24)
- Patient Assessment of Cosmetic Response at Weeks 12, 20, and 24.(Weeks 12, 20, and 24)
- Actinic Keratosis Clearance rate (AKCR)(Weeks 4, 8, 20, and 24)
- Proportion of patients achieving clearance of target lesions in the Treatment Area(Weeks 4, 8, 12, 20, and 24.)
- Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area(Weeks 4, 8, 20, and 24)
- Percent change in total AK lesion count from Baseline to Weeks 4, 8, 12, 20, and 24.(Weeks 4, 8, 12, 20, and 24)
- Partial Clearance Rate (PCR); i.e., proportion of patients achieving partial clearance of AK lesions(Weeks 4, 8, 12, 20, and 24)
- Investigator Assessment of Cosmetic Response at Weeks 12, 20, and 24.(Weeks 12, 20, and 24)
- Recurrence Rate at Week 24(Week 24)
- Patient Satisfaction Score (PSS) at Weeks 12, 20, and 24.(Weeks 12, 20, and 24)
- Actinic Keratosis Clearance rate (AKCR)(Week 12)