EUCTR2015-004382-83-DE进行中（未招募）1 期
A randomized, observer-blind, intra-individual phase III study to evaluate the safety and efficacy of BF 200 ALA (Ameluz®) in combination with daylight-PDT (photodynamic therapy) in comparison with Metvix® for the treatment of mild to moderate actinic keratosis
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
- 50
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
- •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 3 to 9 clinically confirmed AK target lesions of mild to moderate intensity, i.e. AK grade 1 or 2 according to Olsen et al 1991(Olsen et al., 1991), within each of 2 comparable treatment areas located either on opposite sides of the face (excluding eyes, nostrils, ears, and mouth) and/or the scalp. The number of lesions should not vary by more than 50% between the two sides for each patient.
- •AK lesions must be discrete and measurable; the diameter of each AK lesion should be between 0.5 cm and 1.5 cm.
- •Willingness to undergo a biopsy at each patient’s side at the end-of-clinical observation period visit 12 weeks after the last PDT
- •Free of significant physical abnormalities (e.g. tattoos, dermatoses) in the potential treatment areas that may complicate examinations or final evaluations
- •Willingness to stop the use of moisturizers and any other topical treatments within the treatment area(s) 24 h before and 48 h after PDT and within approximately 24 h before a clinical visit that involves lesion counts.
- •Accept to abstain from extensive sunbathing and the use of a solarium during the period of the clinical visits except period of daylight PDT. Patients experiencing sunburn within the treatment areas cannot be included until 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.
- •Negative pregnancy test at screening, if appropriate
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •History of hypersensitivity to 5-ALA, MAL or any ingredient of Ameluz® or Metvix®
- •Current treatment with immunosuppressive therapy
- •Presence of porphyria
- •Hypersensitivity to porphyrins
- •Presence of photodermatoses
- •Presence of other malignant or benign tumors of the skin within the treatment areas (e.g. malignant melanoma, basal cell carcinoma [BCC] or squamous cell carcinoma [SCC]) within the last 4 weeks prior to PDT (V2)).
- •Presence of an inherited or acquired coagulation defect
- •Known confirmed diagnosis of human immunodeficiency virus (HIV) based on clinical history
- •Start of treatment with phototoxic or photoallergic drugs within 8 weeks prior to screening
- •Clinically significant (CS) medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult
- •Evidence of CS, unstable medical conditions such as:
- •- Metastatic tumor or tumor with high probability of metastasis
- •- Cardiovascular disease (New York Heart Association [NYHA] class III, IV)
- •- Immunosuppressive condition
- •-Hematologic, hepatic, renal, neurologic, or endocrine condition
- •- Collagen-vascular condition
- •- Gastrointestinal condition
- •Use of any medicinal topical treatment in the treatment areas within 12 weeks before PDT
- •Any physical treatments for melanoma, AK and NMSC within the treatment areas in the last 4 weeks before PDT
- •Topical treatment with immunomodulatory or cell toxic agents (e.g. imiquimod, ingenol mebutate, 5-FU) or ALA or MAL within 12 weeks prior to the PDT session and during the clinical observation period (except the study specific treatment with Ameluz® and Metvix®)
- •Any of the specified systemic treatments within the designated period before PDT and during the clinical observation period
- •Presence of tattoos, skin inflammation, wounds etc. in close proximity to the treatment area
研究者
相似试验
进行中（未招募）
1 期
Investigation of the effective and safe use of the drug product in the treatment of actinic keratosis with daylightMedDRA version: 18.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersActinic keratosisEUCTR2015-004382-83-ESBiofrontera Bioscience GmbH50
进行中（未招募）
3 期
Double-blind comparison of Chronocort versus standard hydrocortisonereplacement therapy in participants aged 16 years and over with congenital adrenalhyperplasiaJPRN-jRCT2031210491Fujii Katsuya15
进行中（未招募）
1 期
A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitisMedDRA version: 20.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 20.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disordersEUCTR2016-001121-14-SEChemoCentryx, Inc.300
进行中（未招募）
1 期
A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).EUCTR2016-001121-14-ATChemoCentryx, Inc.300
进行中（未招募）
不适用
A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisModerately to severely active rheumatoid arthritisMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2012-002324-32-SEEli Lilly and Company550