EUCTR2013-000973-54-DE进行中（未招募）不适用
Multi-centre, randomized, investigator-blind, intra-individual active and vehicle-controlled study, comparing Metvix® Natural Daylight Photodynamic Therapy versus Metvix® conventional Photodynamic Therapy in subjects with actinic keratosis - Phase 3b study of Metvix NDL-PDT versus Metvix c-PDT in subjects with actinic keratoses
Galderma R&D SNC0 个研究点目标入组 120 人开始时间: 2013年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •- Male or female, who is at least 18 years of age or older,
- •- Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas (TAs) according to Olsen et al scale (1991). (e.g.: thin and/or non-hyperkeratotic AKs),
- •- Subject with two symmetrical TAs (either two half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs
- •- TA comparable in terms of size: 6 by 16 cm at a maximum
- •- A minimum of 5 AKs (either mild, moderate or both) per TA
- •- No more than two lesions difference in number of moderate AKs between the two TAs.
- •- Female of non-childbearing potential, OR female of childbearing potential with a negative urine pregnancy test (UPT).
- •- If female of childbearing potential, they should:
- •- have been strictly abstinent 1 month prior to Baseline and agrees to remain abstinent for the duration of the clinical trial,
- •- and/or agree to use a highly effective and approved contraceptive method(s) during the duration of the clinical trial (bilateral tubal ligation OR combined oral contraceptives (oestrogens and progesterone) or implanted or injectable contraceptives with a stable dose for at least 1 month prior to Baseline OR vasectomized partner for at least 3 months prior to Baseline OR hormonal intra uterine device (IUD) inserted at least 1 month prior to Baseline.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- Subject with clinical diagnosis of at least one severe (Grade 3) AK on TAs according to Olsen et al (1991) scale (e.g. hyperkeratotic AKs),
- •- Subject with pigmented AK on the TAs,
- •- Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons;
- •- Subject with porphyria,
- •- Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs which, in the opinion of the investigator, might interfere with the interpretation of the clinical results,
- •- Subject with systemic diseases that, in the opinion of the investigator might interfere with the interpretation of the clinical results,
- •- History of hypersensitivity to nut products (e.g. peanut and almond oil) or soya,
- •- Subject with a known past history of skin cancer in the TAs
- •- Past history of skin melanoma
- •- The Subject has received, applied or taken the following treatments or Procedures within the specified time frame prior to the Baseline visit:
- •Topical treatment(s) on TAs:
- •5-Fluorouracil, diclofenac, imiquimod, retinoids, ingenol mebutat (Pep-005) : Duration 12 weeks
- •Surgical: elliptical excision, excision and reconstructive surgery, Mohs’ micrographic surgery, chemical peels/chemosurgery, cryosurgery, dermabrasion: Duration 12 weeks
- •PDT: Duration 12 weeks
- •Laser: Duration 12 weeks
- •Electrocoagulation: Duration 12 weeks
- •Radiotherapy and UV radiation therapy: Duration 12 weeks
- •Investigative therapies for Actinic Keratoses: Duration 12 weeks
- •Alpha-hydroxy acid, salicylic acid ointment, urea: Duration 2 weeks
- •Systemic treatment(s)
- •Systemic retinoids: Duration 12 weeks
- •Immunosuppressive drugs (such as glucocorticoids, cytostatic, antibodies, drugs acting on immunophilins, interferon, opioids , TNF binding proteins, Mycophenolate, small biologics agents):Duration 12 weeks
研究者
相似试验
进行中（未招募）
不适用
Study to compare the Metvix® efficacy in eliminating the actinic (solar) keratoses when activated by the natural daylight or by a red lampMild and/or moderate Actinic KeratosesMedDRA version: 14.1Level: HLTClassification code 10020648Term: HyperkeratosesSystem Organ Class: 100000004858EUCTR2013-000973-54-SEGalderma R&D SNC120
进行中（未招募）
1 期
Study to compare the Metvix® efficacy in eliminating the actinic (solar) keratoses when activated by the natural daylight or by a red lampMild and/or moderate Actinic KeratosesMedDRA version: 16.0Level: HLTClassification code 10020648Term: HyperkeratosesSystem Organ Class: 100000004858EUCTR2013-000973-54-ESGalderma R&D SNC131
已完成
3 期
Multi-centre, randomized, investigator-blind, intra-individual active and vehicle-controlled study, comparing Metvix® Natural Daylight Photodynamic Therapy versus Metvix® conventional Photodynamic Therapy in subjects with actinic keratosisActinic (solar) Keratoses. Sunspot10040899NL-OMON38765Galderma24
进行中（未招募）
不适用
Study to compare the Metvix® efficacy in eliminating the actinic (solar) keratoses when activated by the natural daylight or by a red lampEUCTR2013-000973-54-NLGalderma R&D SNC120
尚未招募
不适用
A multicenter, investigator-blinded, randomized, controlled, parallel-group interventional exploratory phase IV trial to evaluate the effect of virtual reality enhanced patient education on illness perception, beliefs about medicines, adherence and disease activity in rheumatoid arthritis – the VIABLE-RA studyM06.00M05.80DRKS00021511Campus Kerckhoff der Justus Liebig Universität Giessen, Abt. für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin60