EUCTR2019-003268-33-DE进行中（未招募）1 期
A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled Dose-escalation and Dose-finding study to Evaluate the Safety and Efficacy of IPN59011 in improving appearance of Moderate to Severe Upper Facial Lines
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 424
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
- •Subjects must fulfil all the following criteria to be included in the study:
- •(1) Provision of written informed consent prior to any study related procedures.
- •(2) Female and male subjects between 18 and 65 years of age, inclusive (for dose escalation, females only)
- •(3) Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the ILA using a validated 4-point photographic scale.
- •(4) Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
- •(5) Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale).
- •(6) Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale).
- •(7) Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL at maximum contraction, as assessed by the SSA using a validated 4-point categorical scale.
- •(8) Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum contraction, as assessed by the SSA using a validated 4-point categorical scale.
- •(9) Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at Baseline, as assessed by the subject’s level of satisfaction.
- •(10) A negative pregnancy test (for females of childbearing potential only). Non-childbearing potential is defined as postmenopausal for at least 1 year; surgical sterilisation at least 3 months before entering the study; or hysterectomy.
- •(11) Subject has both the time and the ability to complete the study and comply with study instructions.
- •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 374
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Subjects will be excluded from the study if they meet any of the
- •following criteria:
- •(1) Previous treatment with any BTX serotype (for dose escalation) or any recent treatment (within the past 6 months prior to Baseline) with any BTX serotype.
- •(2) Any prior treatment with permanent fillers in the upper face
- •including the GL, FHL and LCL area.
- •(3) Any prior treatment with long lasting dermal fillers in the upper face including the GL area within the past 3 years and/or skin
- •abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photo rejuvenation or skin/vascular laser
- •intervention within the 12 months prior to Baseline.
- •(4) Any planned facial cosmetic surgery during the study.
- •(5) A history of eyelid blepharoplasty or brow lift within the past 5
- •(6) An inability to substantially reduce GL by physically spreading them apart or lack of capacity to frown.
- •(7) An active infection or other skin problems in the upper face including the GL, FHL and LCL area (e.g. acute acne lesions or ulcers).
- •(8) Use of concomitant therapy which, in the investigator's opinion,
- •would interfere with the evaluation of the safety or efficacy of the study treatment, including medications affecting bleeding disorders (e.g. antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases).
- •(9) Pregnant women, nursing women, premenopausal women or women of childbearing potential (i.e. not surgically sterile or 1 year
- •postmenopausal) not willing to practice a highly effective form of
- •contraception method at the beginning of the study, for the duration of the study and for a minimum of 12 weeks following last administration of study treatment. Highly effective methods of contraception are defined as methods of birth control which result in a low failure rate (less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intrauterine devices, or vasectomised partner.
- •(10) Male subjects who are not vasectomised and who have female
- •partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation for a minimum of 12 weeks following initial double-blind administration of the treatment.
- •(11) Positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired
- •immunodeficiency syndrome.
- •(12) A history of drug or alcohol abuse.
- •(13) Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its
- •metabolites or if the half-life is unknown within 30 days prior to the start of the study (prior to baseline) and during the conduct of the study.
- •(14) Clinically diagnosed significant anxiety disorder, or any other
- •significant psychiatric disorder (e.g. depression) that might interfere
- •with the subject's participation in the study.
- •(15) Use of medications that affect neuromuscular transmission, such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days prior to Baseline.
- •(16) A history of facial nerve palsy.
- •(17) Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
- •(18) Known allergy or hypersensitivity to BTX, or any excipients of
- •IPN59011 or Azzalure, or aller
研究者
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