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临床试验/EUCTR2020-003746-36-DE
EUCTR2020-003746-36-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 IPN10200 in Improving the Appearance of Moderate to Severe Upper Facial Lines in Adults - LANTIC

Ipsen Innovation0 个研究点目标入组 727 人开始时间: 2020年11月17日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
727
研究概览入排标准研究者记录与标识符相似试验

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

  • •Participants are eligible to be included in the study only if all of the following criteria apply:
  • •1. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • •Type of Participant and Disease Characteristics
  • •2. 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.
  • •3. 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.
  • •4. 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).
  • •5. 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).
  • •6. 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.
  • •7. 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.
  • •8. Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at Baseline, as assessed by the SLS.
  • •9. Male and female participants (only female for dose escalation)
  • •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • •Male participants:
  • •Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study and for 12 weeks after the study intervention injection.
  • •Female participants:
  • •o A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
  • •? -Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4 Contraception and Barrier Guidance.
  • •?-Is a WOCBP and using an acceptable contraceptive method as described in Appendix 4: Contraceptive and Barrier Guidance during the study intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention
  • •o A WOCBP must have a negative highly sensitive pregnancy test at Baseline ([urine or serum]) as required by local regulations). Non-childbearing potential is defined as postmenopausal for at least 1 year; surgical sterilisation at 3 months before entering the study; or hysterectomy.
  • •? -If a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • •o Additional requirements for pregnancy testing during and after study interventi

排除标准

  • •Participants are excluded from the study if any of the following criteria apply:
  • •Medical Conditions
  • •1. 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).
  • •2. A history of eyelid blepharoplasty or brow lift within the past 5 years
  • •3. A history of facial nerve palsy.
  • •4. Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
  • •5. Any known medical condition that may put the participant at increased risk in regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)
  • •6.a Has COVID-19 illness or a known positive SARS-CoV-2 test, or the presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgement of the investigator, might increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
  • •Prior/concomitant Therapy
  • •7. Previous treatment with any BoNT serotype (for dose-escalation only) or any recent treatment (within the past 6 months prior to Baseline) with any BoNT serotype. Participants treated in earlier Stages/Steps of the study should not be included in later Stages/Steps.
  • •8. Any prior treatment with permanent fillers in the upper face including the GL, FHL and LCL area.
  • •9. 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.
  • •10. Any planned facial cosmetic surgery during the study.
  • •11. Use of concomitant therapy which, in the investigator’s opinion, would interfere with the evaluation of the safety or efficacy of the study intervention, including medications affecting bleeding disorders (e.g. antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases).
  • •12. Use of medications that affect neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days prior to Baseline. Topical use of for example aminoglycoside medications on the face apart from the area of injection would be acceptable.
  • •Prior/concurrent Clinical Study Experience
  • •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.
  • •Diagnostic Assessments
  • •14. Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome.
  • •15. Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant’s participation in the study
  • •Other Exclusions
  • •16. An inability to substantially lessen GL and/or horizontal forehead rhytids even by physically spreading them apart as determined by the investigator.
  • •17. Known allergy or hypersen

研究者

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