NCT05662202
进行中（未招募）
3 期
A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED® XL or BF-RhodoLED® Lamp
概览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 172
- 试验地点
- 28
- 主要终点
- Overall subject complete response rate
概览
简要总结
The aim of this study is to test the safety. tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures.
- •4 - 15 mild to moderate clinically confirmed AK lesions according to Olsen either on the extremities or on the neck/trunk with a diameter of ≥ 4 mm that must be present in the treatment field (defined as AK target lesions). In addition, non-target AK lesions may be present in the treatment field, including up to two severe AK lesions ≥ 4 mm. For each severe AK lesion (≥ 4 mm), a biopsy must be taken for confirmation of diagnosis. The treatment field (continuous or in several patches) totaling approx. either 80 cm², 160 cm² or 240 cm2 must be within one effective illumination area of the BF-RhodoLED® XL but may require up to three illuminations with the BF-RhodoLED®. All AK target lesions and, if applicable, severe AK lesions ≥ 4 mm located in the treatment field should be clearly distinguishable, without restrictions on the distance between lesions, and should have a minimal distance of 1 cm to the border of the treatment field.
- •All sexes, ≥ 18 years of age.
- •Willingness to undergo a 2 mm punch biopsy for each (up to two) severe AK lesion ≥ 4 mm, if applicable, at the screening visit.
- •Willingness and ability to comply with study procedures, particularly willingness to receive up to 2 PDTs within approximately 12 weeks.
- •Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study.
- •Willingness to stop the use of moisturizers and any other non-medical topical treatments within the treatment field at least 24 h prior to the next clinical visit.
- •Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the treatment phase.
- •For female subjects with reproductive potential: Negative serum pregnancy test.
- •For female subjects with reproductive potential: Effective contraception at screening visit and throughout the treatment phase of the study (until Visit 4 or Visit 6).
排除标准
- •Any known history of hypersensitivity to ALA, porphyrins, or excipients of BF-200 ALA.
- •History of soy or peanut allergy.
- •Sunburn or other possible confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (\< 2 cm distance) to the treatment field.
- •Clinically significant (cs) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as:
- •Presence of photodermatoses or porphyria
- •Metastatic tumor or tumor with high probability of metastasis
- •Infiltrating skin neoplasia (suspected or known)
- •Unstable cardiovascular disease (New York Heart Association class III, IV)
- •Unstable hematologic (including myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition
- •Unstable collagen-vascular condition
研究组 & 干预措施
BF-200 ALA
Experimental
Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
Red light photodynamic therapy (PDT)
干预措施: BF-200 ALA and red light LED lamp (Combination Product)
Vehicle
Placebo Comparator
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
干预措施: Vehicle and red light LED lamp (Combination Product)
结局指标
主要结局
Overall subject complete response rate
时间窗: 12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of subjects with all AK target lesions clinically cleared after last PDT
次要结局
- Overall subject complete response rate for subjects with lesions treated on extremities(12 weeks after the last PDT (Visit 4 or Visit 6))
- Overall subject complete response rate for subjects with lesions treated on neck/trunk(12 weeks after the last PDT (Visit 4 or Visit 6))
- Complete response rate for severe lesions after PDT-1(12 weeks after PDT-1 (Visit 4))
- Lesion complete response rate(12 weeks after the last PDT (Visit 4 or Visit 6))
- Complete response rate for severe lesions(12 weeks after the last PDT (Visit 4 or Visit 6))
- Esthetic appearance at the end of treatment phase assessed by the investigator(On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6))
- Satisfaction with PDT at the end of treatment phase(On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6))
- Frequency and extent of adverse events (AEs), AEs of Special Interest (AESIs), serious AEs (SAEs) and treatment-emergent AEs (TEAEs) during treatment phase(Entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6))
- Assessment of application site reactions(All visits (except screening, Visit 1) throughout entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6))
- Lesion complete response rate after PDT-1(12 weeks after PDT-1 (Visit 4))
- Subject complete response rate after PDT-1(12 weeks after PDT-1 (Visit 4))
- Esthetic outcome at the end of treatment phase assessed by the subject(On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6))
- New lesions inside the treatment field during treatment phase(All clinical visits throughout entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6))
- Application site pain during illumination(During treatment (illumination) on treatment day for PDT-1 (Visit 2, up to 4 weeks after screening) and during treatment (illumination) on treatment day for PDT-2 (Visit 4; if applicable; 12 weeks after PDT-1))
- Number of patients with significant changes of vital signs(All clinical visits throughout entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6))
- Number of patients with significant changes in safety laboratory(All clinical visits throughout entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6))
- Number of patients with abnormal findings in physical examination(At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6))
研究者
研究点 (28)
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