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评估 BF-200 ALA (Ameluz®) 在使用 RhodoLED 灯进行光动力疗法 (PDT) 的四肢和颈部/躯干光化性角化病 (AK) 场定向治疗中的安全性、耐受性和有效性的研究

2026年7月30日 更新者：Biofrontera Inc.

一项随机、双盲、车辆控制、多中心 III 期研究，以评估 BF-200 ALA (Ameluz®) 在四肢和颈部/躯干光化性角化病的现场治疗中的安全性、耐受性和有效性使用 BF-RhodoLED® XL 或 BF-RhodoLED® 灯的光动力疗法 (PDT)

本研究的目的是测试安全性。 使用 10% 氨基乙酰丙酸凝胶（Ameluz®、BF-200 ALA）的场定向光动力疗法 (PDT) 与其中一种窄光谱红光 RhodoLED 灯相结合的耐受性和有效性，与媒介物治疗光化性角化病 (AK) 的比较在四肢和颈部/躯干上。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

172

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85032
        • Alliance Dermatology & Mohs Center
      • Phoenix、Arizona、美国、85006
        • Medical Dermatology Specialists
    • Colorado
      • Greenwood Village、Colorado、美国、80111
        • Dermatology Practice
    • Florida
      • Delray Beach、Florida、美国、33445
        • Dermatology Associates PA of the Palm Beaches
    • Georgia
      • Snellville、Georgia、美国、30078
        • Gwinnett Clinical Research Center, Inc.
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • Laser and Skin Surgery Center of Indiana
      • Plainfield、Indiana、美国、46168
        • The Indiana Clinical Trials Center, PC
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • DelRicht Research
    • New York
      • Rochester、New York、美国、14623
        • Skin Search Of Rochester, Inc.
      • Victor、New York、美国、14564
        • Rochester Dermatologic Surgery
    • South Carolina
      • Charleston、South Carolina、美国、29407
        • Clinical Research Center of the Carolinas
    • Texas
      • Austin、Texas、美国、78759
        • DermResearch, P.A.
      • Houston、Texas、美国、77056
        • Austin Institute for Clinical Research
      • Pflugerville、Texas、美国、78660
        • Austin Institute for Clinical Research Inc.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 受试者提供知情同意并签署《健康保险流通与责任法案》(HIPAA) 表格的意愿和能力。 在开始任何研究程序之前，必须以书面形式获得特定于研究的知情同意书和 HIPAA 表格。
  2. 根据 Olsen 的说法，在四肢或颈部/躯干上有 4 - 15 个轻度至中度临床证实的 AK 病灶，直径 ≥ 4 毫米，必须存在于治疗区域（定义为 AK 目标病灶）。 此外，治疗野中可能存在非目标 AK 病灶，包括多达两个 ≥ 4 mm 的严重 AK 病灶。 对于每个严重的 AK 病变（≥ 4 mm），必须进行活检以确认诊断。 治疗领域（连续或几个补丁）总计约。 80 cm²、160 cm² 或 240 cm2 必须在 BF-RhodoLED® XL 的一个有效照明区域内，但 BF-RhodoLED® 可能需要多达三个照明。 所有 AK 靶病灶和（如果适用）位于治疗野内的 ≥ 4 mm 的严重 AK 病灶应清晰可辨，病灶之间的距离不受限制，并且与治疗野边界的最小距离应为 1 cm。
  3. 所有性别，≥ 18 岁。
  4. 愿意在筛选访视时对每个（最多两个）≥ 4 mm 的严重 AK 病变（如果适用）进行 2 mm 穿刺活检。
  5. 愿意并有能力遵守研究程序，特别是愿意在大约 12 周内接受最多 2 次 PDT。
  6. 一般健康状况良好或临床稳定的医疗条件的受试者将被允许纳入研究。
  7. 愿意在下次临床就诊前至少 24 小时停止使用润肤霜和任何其他非医疗局部治疗。
  8. 同意在治疗阶段避免大量日光浴和使用日光浴室或日光浴床。
  9. 对于具有生殖潜力的女性受试者：血清妊娠试验阴性。
  10. 对于具有生殖潜力的女性受试者：在筛选访视和整个研究治疗阶段（直到访视 4 或访视 6）时采取有效避孕措施。

排除标准：

  1. 任何已知的对 ALA、卟啉或 BF-200 ALA 赋形剂的过敏史。
  2. 大豆或花生过敏史。
  3. 在治疗区域内部或附近（< 2 cm 距离）晒伤或其他可能混杂的皮肤状况（例如，伤口、刺激、出血或皮肤感染）。

  4. 具有临床意义的 (cs) 医疗条件使方案的实施或研究结果的解释变得困难或损害受试者的安全，例如：

    1. 光性皮肤病或卟啉症的存在
    2. 转移性肿瘤或转移概率高的肿瘤
    3. 浸润性皮肤肿瘤（疑似或已知）
    4. 不稳定的心血管疾病（纽约心脏协会 III、IV 级）
    5. 不稳定的血液学（包括骨髓增生异常综合征）、肝、肾、神经或内分泌疾病
    6. 不稳定的胶原血管状况
    7. 胃肠道状况不稳定
    8. 免疫抑制状态
    9. 存在有临床意义的遗传性或获得性凝血缺陷
  5. 特应性皮炎、Bowen 病 (BD)、基底细胞癌 (BCC)、湿疹、银屑病、酒渣鼻、鳞状细胞癌 (SCC)、内部或附近（< 2 cm 距离）其他恶性或良性肿瘤的临床诊断到治疗领域。
  6. 存在强烈的人工色素沉着（例如纹身）或任何其他可能影响治疗区域的病变评估或光穿透的异常。
  7. 任何物理疗法，例如冷冻疗法、激光疗法、电疗、微晶换肤术、手术切除病灶、刮除术，或在手术前 4 周内在治疗区域内部或附近（< 10 厘米距离）使用三氯乙酸等化学换肤治疗筛选。

  8. 在筛选前的指定时间内进行以下定义的任何局部治疗：

    1. 在 3 个月内在治疗区域内使用 ALA 或 ALA 酯（例如甲基氨基乙酰丙酸 (MAL)）进行局部治疗。
    2. 在 3 个月内在治疗区域内部或附近（< 10 cm 距离）使用免疫调节、细胞抑制剂或细胞毒性药物进行局部治疗。
    3. 在 4 周内在治疗区域内部或附近（< 10 cm 距离）开始局部使用金丝桃素或其他具有光毒性或光过敏潜能的药物。 然而，如果在筛选前应用此类药物超过 4 周且没有实际光毒性/光过敏反应的证据，则受试者可能符合条件。

  9. 在筛选前的指定时间内使用全身治疗：

    1. 6 个月内使用细胞抑制剂或细胞毒性药物。
    2. 12 周内接受免疫抑制疗法或 ALA 或 ALA 酯（例如 MAL）。
    3. 已知在 8 周内具有主要器官毒性的药物。
    4. 6 周内使用干扰素或糖皮质激素。
    5. 在筛选前 8 周内开始服用金丝桃素或具有光毒性或光过敏潜能的药物。 但是，如果在筛选访视之前服用此类药物超过 8 周，而没有实际光毒性/光过敏反应的证据，则受试者可能符合条件。
  10. 母乳喂养的妇女。
  11. 怀疑吸毒或酗酒。
  12. 受试者不太可能遵守协议，例如，无法返回访问、不太可能完成研究或研究者认为不合适。
  13. 直接参与方案实施的研究中心工作人员或赞助商工作人员或其近亲。
  14. 在筛选或同时参与另一项临床研究之前的 8 周内收到任何研究药物或医疗产品。

一旦满足排除标准 3 并且可以在 4 周内获得资格，则允许重新评估受试者。 可以在实际治疗当天进行重新评估。

给药日排除标准：

访问 2（基线，PDT-1）

在治疗区内或附近（< 2 cm 距离）有晒伤或其他可能混杂的皮肤状况（例如，伤口、刺激、出血或皮肤感染）的受试者。 如果晒伤或其他混杂的皮肤状况预计会在 2 周内消退，则允许对受试者进行一次重新评估。

第 4 次访问 (PDT-2)

在治疗区内或附近（< 2 cm 距离）有晒伤或其他可能混杂的皮肤状况（例如，伤口、刺激、出血或皮肤感染）的受试者。 PDT-2的改期可在解决后尽早进行一次，但改期不应超过2周。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：车辆
将载体局部应用于不含活性成分的 BF-200 ALA。 红光光动力疗法 (PDT)
组合产品：车用及红光LED灯

使用 RhodoLED 灯（RhodoLED® XL 或 BF-RhodoLED®）的最多两个 PDT（车辆-PDT）：

在扩大的治疗区域（最多 240 平方厘米）上局部应用最多 3 管载体，然后在封闭敷料下研究药物孵育 3 小时后用 RhodoLED 灯进行红光照明。

PDT-1 将在第 2 次就诊时进行。临床清除率将在 PDT-1（第 4 次就诊）后 12 周进行评估。 如果在第 4 次就诊时仍有病变，将在同一次就诊时进行 PDT-2。
实验性的：BF-200 ALA

Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).

Red light photodynamic therapy (PDT)
组合产品：BF-200 ALA和红光LED灯

使用 RhodoLED 灯（RhodoLED® XL 或 BF-RhodoLED®）（ALA-PDT、Ameluz®-PDT）的最多两个 PDT：

将最多 3 管 BF-200 ALA 局部应用于扩大的治疗区域（最多 240 平方厘米），然后在封闭敷料下研究药物孵育 3 小时后用 RhodoLED 灯进行红光照明。

PDT-1 将在第 2 次就诊时进行。临床清除率将在 PDT-1（第 4 次就诊）后 12 周进行评估。 如果在第 4 次就诊时仍有病变，将在同一次就诊时进行 PDT-2。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Subject Complete Response Rate
大体时间：12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of subjects with all AK target lesions clinically cleared after last PDT
12 weeks after the last PDT (Visit 4 or Visit 6)

次要结果测量

结果测量
措施说明
大体时间
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Extremities
大体时间：12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of subjects with all AK target lesions on extremities clinically cleared after last PDT
12 weeks after the last PDT (Visit 4 or Visit 6)
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Neck/Trunk
大体时间：12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of subjects with all AK target lesions on neck/trunk clinically cleared after last PDT
12 weeks after the last PDT (Visit 4 or Visit 6)
Lesion Complete Response Rate
大体时间：12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after the last PDT, overall and stratified by treatment area and AK severity at baseline (according to Olsen).
12 weeks after the last PDT (Visit 4 or Visit 6)
Complete Response Rate for Severe Lesions
大体时间：12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen; Visit 2) after the last PDT, overall and stratified by treatment area.
12 weeks after the last PDT (Visit 4 or Visit 6)
Subject Complete Response Rate After PDT-1
大体时间：12 weeks after PDT-1 (Visit 4)
Percentage of subjects with all AK target lesions clinically cleared after PDT-1, overall and stratified by AK baseline parameters.
12 weeks after PDT-1 (Visit 4)
Lesion Complete Response Rate After PDT-1
大体时间：12 weeks after PDT-1 (Visit 4)
Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after PDT-1, overall and stratified by treatment area and AK severity at baseline (according to Olsen [mild, moderate, severe]).
12 weeks after PDT-1 (Visit 4)
Complete Response Rate for Severe Lesions After PDT-1
大体时间：12 weeks after PDT-1 (Visit 4)
Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen [mild, moderate, severe]; Visit 2) after PDT-1, overall and stratified by treatment area.
12 weeks after PDT-1 (Visit 4)
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
大体时间：On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
The esthetic appearance after the last PDT as assessed by the investigator according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area.
On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
大体时间：On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
The esthetic outcome after the last PDT as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area.
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
大体时间：On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Satisfaction with PDT treatment after the last PDT as assessed by the subject; overall and stratified by treatment area. Therefore, subjects were asked if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no).
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
大体时间：During entire treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)

Frequency and extent of AEs, AESIs, SAEs, and TEAEs, overall and stratified by demographics, skin type class (I-III and IV-VI), size of the treatment field, and treatment area.

TEAEs were defined as all AEs starting with or after IMP application and within 12 weeks (+ 7 days) after the last PDT, or as related AEs (possibly, probably, or definitely related, or with missing relationship) occurring more than 12 weeks after the last PDT.
During entire treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
New Lesions Inside the Treatment Field During Treatment Phase
大体时间：All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
New lesions: AK, non-melanoma skin cancer [NMSC, including Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) or Bowen's Disease (BD)] or melanoma
All clinical visits throughout the treatment phase, 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
大体时间：All visits (except screening, Visit 1) throughout the treatment phase, 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 reactions (bleeding, burning, discharge, edema, erosion, erythema, exfoliation, hyperalgesia, induration, irritation, paraesthesia, pruritus, pustules, scabbing, or vesicles) were assessed on a 4-point scale: grade 0 = none, grade 1 = mild, grade 2 = moderate, grade 3 = severe. The worst severity across all assessment timepoints and illumination areas is presented.
All visits (except screening, Visit 1) throughout the treatment phase, 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
大体时间：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)
Reported by the subjects assessed on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain); overall and stratified by size of the treatment field and treatment area. The maximum of pain score over all illuminations is shown.
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
大体时间：All clinical visits throughout the treatment phase, 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 changes in blood pressure (systolic and diastolic) [mmHg] and changes in pulse rate [beats/min]. Findings which differed from reference range and were considered clinically significant were to be reported.
All clinical visits throughout the treatment phase, 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
大体时间：All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Changes in clinical chemistry, in hematology and urinalysis parameters as defined in the protocol. Findings which differed from reference range and were considered clinically significant were to be reported.
All clinical visits throughout the treatment phase, 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
大体时间：At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6)
Physical examination of head, neck, skin, lymph nodes, thorax including heart and lungs, abdomen, and musculoskeletal, peripheral vascular and nervous system status were to be performed. Abnormal findings considered clinically significant were to be reported.
At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6)

其他结果措施

结果测量
措施说明
大体时间
Subject Recurrence Rate
大体时间：On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The percentage of subjects with all AK target lesions clinically cleared 12 weeks after the last PDT presenting with at least one recurrent lesion during follow-up, stratified by demographics, study sites, AK baseline parameters
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Lesion Recurrence Rate
大体时间：On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The percentage of AK target lesions showing recurrence in follow-up in relation to total number of clinically cleared AK target lesions 12 weeks after last PDT; overall and stratified by treatment area and AK severity at baseline (according to Olsen [mild, moderate, severe])
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Recurrence Rate of Severe Lesions
大体时间：On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The percentage of severe AK lesions (according to Olsen [mild, moderate, severe]) showing recurrence in follow-up in relation to total number of clinically cleared severe AK lesions 12 weeks after last PDT; overall and stratified by treatment area
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Esthetic Appearance at Follow-up Visits Assessed by the Investigator
大体时间：On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The esthetic outcome at follow-up visits as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Esthetic Outcome at Follow-up Visits Assessed by the Subject
大体时间：On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The esthetic outcome at follow-up visits as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Satisfaction With PDT at Follow-up Visits
大体时间：On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Satisfaction with PDT treatment after the last PDT as assessed by the subject via questionnaire, 1. if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no) and 2. how they would rate the PDT treatment in comparison to other treatment modalities, if applicable (better than/ similar/ worse). The treatment modalities should be documented, if applicable); overall and stratified by treatment area
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Any SAE and Relevant AE
大体时间：Entire follow-up duration, approx. 40 weeks
Relevant AEs include AEs or conditions affecting skin health in the treatment field which may impair proper assessment of the recurrence rate of the treated AK lesions, or other clinically relevant events at the investigator's discretion as well as any SAE that has occurred since the final visit of the treatment phase (Visit 4 or Visit 6); overall and stratified by demographics and treatment area
Entire follow-up duration, approx. 40 weeks
New Lesions Inside the Treatment Field During Follow-up
大体时间：On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
New lesions: AK, non-melanoma skin cancer [NMSC, including BCC, SCC or BD] or melanoma
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Biofrontera Inc.

调查人员

  • 首席研究员：Nathalie Zeitouni, MD、Medical Dermatology Specialists; Phoenix, Arizona, United States

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年12月12日

初级完成 (实际的)

2025年9月3日

研究完成 (实际的)

2026年7月1日

研究注册日期

首次提交

2022年11月29日

首先提交符合 QC 标准的

2022年12月20日

首次发布 (实际的)

2022年12月22日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ALA-AK-CT019

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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