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临床试验/NCT05662202
NCT05662202已完成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

Biofrontera Inc.28 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2022年12月12日最近更新:
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适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
172
试验地点
28
主要终点
Overall subject complete response rate
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

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
  • •Unstable gastrointestinal condition
  • •Immunosuppressive condition
  • •Presence of clinically significant inherited or acquired coagulation defect
  • •Clinical diagnosis of atopic dermatitis, Bowen´s disease (BD), basal cell carcinoma (BCC), eczema, psoriasis, rosacea, squamous cell carcinoma (SCC), other malignant or benign tumors inside or in close proximity (< 2 cm distance) to the treatment field.
  • •Presence of strong artificial pigmentation (e.g., tattoos) or any other abnormality that may impact lesion assessment or light penetration in the treatment field.
  • •Any physical therapy such as cryotherapy, laser therapy, electrodessication, microdermabrasion, surgical removal of lesions, curettage, or treatment with chemical peels such as trichloroacetic acid inside or in close proximity (< 10 cm distance) to the treatment field within 4 weeks prior to screening.
  • •Any of the topical treatments defined below within the designated periods prior to screening:
  • •Topical treatment with ALA or ALA esters (e.g., methyl aminolevulinic acid (MAL)) inside the treatment field within 3 months.
  • •Topical treatment with immunomodulatory, cytostatic, or cytotoxic drugs inside or in close proximity (< 10 cm distance) to the treatment field within 3 months.
  • •Start of topical administration of a medication with hypericin or other drugs with phototoxic or photoallergic potential inside or in close proximity (< 10 cm distance) to the treatment field within 4 weeks. Subjects may, however, be eligible if such medication was applied for more than 4 weeks prior to screening without evidence of an actual phototoxic/photoallergic reaction.
  • •Any use of the systemic treatments within the designated periods prior to screening:
  • •Cytostatic or cytotoxic drugs within 6 months.
  • •Immunosuppressive therapies or ALA or ALA esters (e.g., MAL) within 12 weeks.
  • •Drugs known to have major organ toxicity within 8 weeks.
  • •Interferon or glucocorticosteroids within 6 weeks.
  • •Start of intake of medication with hypericin or drugs with phototoxic or photoallergic potential within 8 weeks prior to screening. Subjects may, however, be eligible if such medication was taken in for more than 8 weeks prior to the screening visit without evidence of an actual phototoxic/photoallergic reaction.
  • •Breast feeding women.
  • •Suspicion of drug or alcohol abuse.
  • •Subjects unlikely to comply with protocol, e.g., inability to return for visits, unlikely to complete the study, or inappropriate in the opinion of the investigator.
  • •A member of study site staff or sponsor staff directly involved in the conduct of the protocol or a close relative thereof.
  • •Receipt of any investigational drug or medical product within 8 weeks before screening or simultaneous participation in another clinical study.
  • •Reassessment of subjects is allowed once in case exclusion criterion 3 is met and eligibility can be achieved within 4 weeks. Reassessment can be done on the day of the actual treatment.
  • •Dosing day exclusion criteria:
  • •At Visit 2 (baseline, PDT-1)
  • •Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (< 2 cm distance) to the treatment field. Reassessment of subjects is allowed once if the sunburn or other confounding skin conditions is/are expected to resolve within 2 weeks.
  • •At Visit 4 (PDT-2)
  • •Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (< 2 cm distance) to the treatment field. Rescheduling of PDT-2 can be performed once at the earliest possibility after resolution, but rescheduling should not exceed 2 weeks.

研究组 & 干预措施

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)

BF-200 ALA

Experimental

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

Red light photodynamic therapy (PDT)

干预措施: BF-200 ALA 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

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))
  • 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))
  • 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))
  • Subject Complete Response Rate After PDT-1(12 weeks after PDT-1 (Visit 4))
  • Lesion Complete Response Rate After PDT-1(12 weeks after PDT-1 (Visit 4))
  • Complete Response Rate for Severe Lesions After PDT-1(12 weeks after PDT-1 (Visit 4))
  • 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))
  • 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))
  • 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(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(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(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(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 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(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(At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (28)

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