EUCTR2007-006854-24-FR进行中（未招募）1 期
A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of a nanoemulsion gel formulation BF-200 ALA, in comparison with Metvix® and placebo, for the treatment of actinic keratosis with photodynamic therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 616
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
- 性别
- All
入选标准
- •Main inclusion criteria:
- •1) Written Informed Consent
- •2) Men and women between 18 and 85 years of age
- •3) 4-8 actinic keratosis lesions of 0.5 to 1.5 cm diameter of mild to moderate intensity (Olsen grade 1 and 2) in the face and/or on the bald scalp. Lesions on the eyes, nostrils, ears and mouth will not be considered for a treatment during the planned study.
- •4) Target actinic keratosis (AK) lesions must be discrete and quantifiable; adjacent AK lesions must show a minimum distance of 1.0 cm from one another
- •5) Confirmation of AK by biopsy taken at screening
- •6) Free of significant physical abnormalities (e.g. tattoos, dermatoses) in the potential treatment region that may cause difficulty with examination or final evaluation
- •7) Willingness to stop the use of moisturizers and any other topical treatments within the treatment region
- •8) Good general health condition
- •9) Healthy patients and patients with clinically stable medical conditions including, but not limited to the following diseases (controlled hypertension, diabetes mellitus type II, hypercholesterolemia, 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
- •10) No extensive sunbathing or solarium use during the trial
- •11) Negative pregnancy test at screening
- •12) Effective contraception in women of childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main exclusion criteria:
- •1) Known hypersensitivity to BF-200 ALA, MAL (methyl-aminolevulinic acid) and/or any of the ingredients of the formulations
- •2) Clinically significant medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult
- •3) Presence of photodermatoses
- •4) Presence of other tumors in the treatment areas within the last 4 weeks
- •5) Intake of phototoxic or photoallergic drugs
- •6) Current treatment with immunosuppression therapy
- •7) Hypersensitivity to porphyrins
- •8) Presence of porphyria
- •9) Presence of inherited or acquired coagulation defect
- •10) Any topical treatment within the treatment area within 12 weeks before PDT-1
- •11) Topical treatment with ALA or MAL outside the treatment area during participation in the study
- •12) None of the specified systemic treatments within the designated period before PDT-1
研究者
相似试验
进行中（未招募）
不适用
A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of a nanoemulsion gel formulation BF-200 ALA, in comparison with Metvix® and placebo, for the treatment of actinic keratosis with photodynamic therapyActinic keratosis (AK)MedDRA version: 9.1Level: LLTClassification code 10000614Term: <Manually entered code. Term in E.1.1>EUCTR2007-006854-24-ATBiofrontera Bioscience GmbH616
进行中（未招募）
不适用
A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of a nanoemulsion gel formulation BF-200 ALA, in comparison with Metvix® and placebo, for the treatment of actinic keratosis with photodynamic therapyActinic keratosis (AK)MedDRA version: 9.1Level: LLTClassification code 10000614Term: <Manually entered code. Term in E.1.1>EUCTR2007-006854-24-DEBiofrontera Bioscience GmbH616
进行中（未招募）
1 期
Investigation of the effective and safe use of the drug product in the treatment of basal cell carcinomaEUCTR2013-003241-42-DEBiofrontera Bioscience GmbH394
进行中（未招募）
1 期
Investigation of the effective and safe use of the drug product in the treatment of basal cell carcinomaEUCTR2013-003241-42-GBBiofrontera Bioscience GmbH394
进行中（未招募）
1 期
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal OsteoporosisMedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersPostmenopausal OsteoporosisEUCTR2020-005548-48-DETeva Branded Pharmaceutical Products R&D, Inc.326