EUCTR2017-000486-72-DE进行中（未招募）1 期
A randomized, double-blind, intra-individual, multi-center phase III study to evaluate the safety and efficacy of BF 200 ALA (Ameluz®) versus placebo in the treatment of mild to severe actinic keratosis on extremities, trunk/ neck with photodynamic therapy (PDT) when using the BF-RhodoLED® lamp.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Males or females between 18 and 85 years of age (inclusive)
- •Willing and able to sign the informed consent form. A study-specific informed consent must be obtained in writing for all patients before starting any study procedures.
- •Presence of at least 4 to 10 clinically confirmed AK target lesions of mild to severe severity (according to Olsen (Olsen et al., 1991)) on one treatment field (continuously or in several patches) totaling about 20 cm2 per comparable patient’s side. Treatment fields can be allocated to the treatment areas extremities (including hands, arms, feet, legs) and/or trunk/ neck, but treatment fields on both sides of a patient must be in comparable locations (subareas) within the same treatment area (e.g. both treatment fields on hands or upper arms or lower arms or upper legs or lower legs or décolleté or back, but not for instance hand on one side of the body and arm on the other). Treatment fields on the left and on the right side should be comparable also regarding AK severity grade and AK lesion number, which should not deviate by more than 50%. AK lesions should be clearly distinguishable; however, no distance restrictions between lesions will be applied. Lesions should measure at least 0.3 cm in diameter and have an upper limit of 1.5 cm. Lesions included in the study should be entirely located within the treatment fields, leaving a minimal distance of = 0.5 cm between the lesion margin and the treatment field border. At least one of the lesions on each side must have a diameter of = 0.5 cm to be selected for 2 mm punch biopsies. One entire tube (2 g) of IMP will be applied to the treatment field on each of both patient’s sides at a thickness of 1 mm and lesions should be located such that the lesions and the margins can be covered.
- •Willingness to undergo a 2 mm punch biopsy on each side at the end-of-study visit 12 weeks after the last PDT. One appropriate, distinct lesion on each side will be pre-selected for biopsy at visit 1. The lesions selected for the punch biopsies should have a size of = 0.5 cm and should be similar with respect to size and Olsen grade.
- •Free of significant physical abnormalities (e.g. tattoos, dermatoses) in the potential treatment fields that may complicate examinations or final evaluations.
- •Willingness to stop the use of moisturizers and any other non-medical topical treatments within the treatment fields at least 24 h prior to the next clinical visit.
- •Accept to abstain from extensive sunbathing and the use of a solarium during the period of the clinical visits. Patients experiencing sunburn within the treatment fields cannot be randomized before they have fully recovered.
- •Good general health and/or stable health condition, as confirmed by a physical examination and medical history.
- •Healthy patients and patients with clinically stable medical conditions including, but not limited to, the following diseases: controlled hypertension, diabetes mellitus type II, hypercholesterolemia, and osteoarthritis will be permitted to be included into the study if the medication taken for the treatment of the disease does not match an exclusion criterion or is specified as prohibited concomitant medication.
- •For female patients with reproductive potential: Negative pregnancy test at screening.
- •For female p
排除标准
- •History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA.
- •Presence of porphyria.
- •Hypersensitivity to porphyrins.
- •Presence of photodermatosis.
- •Start of treatment with phototoxic or photoallergic drugs within 8 weeks prior to screening.
- •Presence of clinically significant inherited or acquired coagulation defect.
- •Clinically significant (CS) medical conditions making implementation of the protocol or interpretation of the study results difficult such as:
- •Known diagnosis of human immunodeficiency virus (HIV) based on clinical history, Metastatic tumor or tumor with high probability of metastasis, Cardiovascular disease (New York Heart Association [NYHA] class III, IV), Hematologic (including Myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition, Collagen-vascular condition, Gastrointestinal condition
- •Immunosuppressive condition.
- •Current treatment with immunosuppressive therapy.
- •Presence of malignant or benign tumors of the skin within the treatment fields (e.g. malignant melanoma, basal cell carcinoma [BCC] or squamous cell carcinoma [SCC]) within the last 4 weeks prior to PDT-1 (Visit 2) until the end of the clinical phase.
- •Physical treatment of malignant or benign tumors of the skin within the treatment fields and at a distance of < 10 cm from the nearest target lesion within the treatment fields during the last 4 weeks prior to PDT-1 (Visit 2) until the end of the clinical phase.
- •Any topical medical treatment of the skin within the treatment fields 12 weeks before visit 2 (PDT-1) until the end of the clinical phase. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are restricted to not to be used 7 days prior and after each PDT in- and outside the treatment fields. However, diclofenac up to 2.5% may be used outside treatment fields throughout the study.
- •Any topical, medical treatment of AK and NMSC inside/ outside the treatment fields (except for IMP treatment) within 12 weeks before visit 2 (PDT-1) until end of clinical phase: (i) Topical treatment with ALA (except IMP) or methyl-aminolevulinate (MAL) in- and outside the treatment fields during the clinical observation period and 12 weeks prior to PDT-1, (ii) Topical treatment with immunomodulatory, cell toxic agents (e.g. imiquimod, ingenol mebutate, 5-FU) or diclofenac/ hyaluronic acid in- and outside the treatment fields during the clinical observation period and 12 weeks prior to PDT-1.
- •Any of the specified systemic treatments within the designated period before PDT-1 and during the clinical observation period (for details of the specific treatments see Clinical Study Protocol section Protocol Outline- exclusion criteria).
- •Intake and/or systemic treatment with NSAIDs is restricted to not to be used 7 days prior and after each PDT. ASS up to 100 mg/day, Ibuprofen up to 200 mg/day is allowed in this period.
- •Presence of tattoos, skin inflammation, wounds, etc. in close proximity (< 10 cm distance) to treatment fields.
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