NCT07779252招募中3 期
A Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of IPN10200 in the Improvement of the Appearance of Moderate To Severe Glabellar Lines in Adult Chinese Participants
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Ipsen
- 入组人数
- 160
- 试验地点
- 9
- 主要终点
- Percentage of participants responding to treatment
研究概览
简要总结
The purpose of this study is to find out about the effectiveness and safety of a single dose of corabotase (also known as IPN10200) compared to placebo works in participants with moderate to severe glabellar lines. Glabellar lines are wrinkle-like lines that appear between the eyebrows and can become more noticeable with age or repeated facial expressions. They may affect a person's appearance and confidence.
In this study, all participants will receive a single injection of either corabotase (the study drug) or placebo. There will be 3 periods in this study:
- A screening period (up to 20 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.
- A treatment period (Day 1) where all the eligible participants will receive a single injection of corabotase or placebo.
- A follow-up period (52 weeks) where participants' health will be monitored, consisting of regular visits to the study centre and 1 telephone call visit.
Participants will undergo health measurements and observation, including blood sampling, physical examinations, and clinical evaluations. They will also be asked to fill in questionnaires and keep a diary. Each participant will be in this study for up to 55 weeks. Participants may withdraw consent to participate at any time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant should be male or female, ≥18 years of age inclusive at the time of signing the ICF.
- •Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA using a validated 4-point photographic scale.
- •Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA using a 4-point categorical scale.
- •Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at baseline, as assessed by the SLS.
- •If female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Participant has both the time and the ability to complete the study and comply with study instructions.
- •Is not a sponsor employee or clinical research unit personnel directly affiliated with the study or is not an immediate family member. Immediate family is defined as a spouse, parent, child or sibling whether biological or legally adopted.
排除标准
- •An active infection or other skin problems in the upper face including the GL area (e.g. acute acne lesions or ulcers).
- •A history of eyelid blepharoplasty or brow lift or any other upper facial surgery within the past 5 years.
- •A history of facial nerve palsy.
- •Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
- •Presence of any scars, piercings or tattoos (including micro blading of the eyebrows) in or around the treatment area that have occurred within 6 months prior to baseline, or which in the investigator's opinion, could interfere with evaluations.
- •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.).
- •Closed-angle glaucoma or a predisposition to it.
- •Participants who have received IPN10200 in a previous study.
- •Administration of any BoNT (other than the study intervention at the baseline visit) into any site of the body and for any indication from 9 months prior to the first study visit until the EOS
- •Use of medications that affect neuromuscular transmission (such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases) within the past 30 days prior to baseline are prohibited or a longer washout period of at least five half-lives might be required, as deemed appropriate by the investigator for long-acting medications.
- •Use of aminoglycoside antibiotics within the past 30 days prior to baseline are prohibited. Note: Topical use apart from the area of injection would be acceptable.
- •Use of systemic retinoids within the past 30 days prior to baseline and planned use during the study. Note: Topical retinoids are allowed other than in the areas that will be injected (upper facial area) at the discretion of the investigator.
- •Any prior treatment with permanent fillers, lifting threads, autologous fat or permanent procedures in the upper face including the GL area.
- •Administration of any non-permanent injectables (such as hyaluronic acid, calcium hydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) soft tissue augmentation therapy in the GL region within 12 months prior to baseline.
- •Any prior facial treatment or aesthetic procedures to the upper face including photo rejuvenation, vascular or pigment laser or microneedling within the 3 months prior to baseline.
- •Any prior facial treatment or aesthetic procedures to the upper face involving skin resurfacing (including dermabrasion, laser or whatever the interventional technique used) or chemical peel within the past 12 months prior to baseline.
- •Any planned cosmetic surgery or aesthetic procedures to the upper face during the study and/or any procedures to other parts of the face which in the investigator's opinion, could interfere with evaluations during the study.
- •Any past surgery in the UFL area including GL.
- •Planned use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention. Therapy considered necessary for the participant's welfare may be given at the discretion of the investigator. Note: If the permissibility of a specific medication/treatment is in question, the medical monitor will be contacted.
- •Use of any experimental device within 30 days prior to baseline visit 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 visit) and during the conduct of the study.
- •Known positive for hepatitis B antigen, hepatitis C virus antibody or for human immunodeficiency virus or a diagnosis of acquired immunodeficiency syndrome.
- •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.
- •An inability to substantially lessen GL as determined by the investigator.
- •Known allergy or hypersensitivity to BoNT or any excipients of IPN
- •A history of chronic or recreational drug abuse as assessed by the investigator.
- •Any uncontrolled systemic disease or other significant medical condition which would be harmful for the participant to be entered into the study or continue participation.
研究组 & 干预措施
Corabotase group
Experimental
Participants will receive corabotase through injections into the selected muscles on Day 1.
干预措施: Corabotase (Biological)
Placebo group
Placebo Comparator
Participants will receive placebo through injections into the selected muscles on Day 1.
干预措施: Placebo (Biological)
结局指标
主要结局
Percentage of participants responding to treatment
时间窗: At Week 4
Measured by the multicomponent response of ≥2-grade improvement from baseline and a score of 'None' or 'Mild' on Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) at maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles.
次要结局
- Percentage of participants responding to treatment as measured by a score of 'None' or 'Mild' at Week 24 on the ILA at maximum frown.(At Week 24)
- Percentage of participants responding to treatment(From baseline to each post-treatment visit except Week 4 (up to 55 Weeks))
- Percentage of participants responding to treatment as measured by a score of 'None' or 'Mild' on the ILA at maximum frown at each post treatment visit except Week 24.(From baseline to each post-treatment, except Week 24 (up to 55 Weeks))
- Percentage of participants responding to treatment as measured by a score of 'None' or 'Mild' on the SSA at maximum frown at each post treatment visit.(From baseline to each post-treatment (up to 55 Weeks))
- Percentage of participants with ≥1-grade improvement on the ILA at maximum frown at each post treatment visit(From baseline to each post-treatment visit (up to 55 Weeks))
- Percentage of participants with binding antibodies to corabotase(At screening, week 4, 12, 24, 36, 52)
- Percentage of participants with ≥1-grade improvement on the SSA at maximum frown at each post treatment visit(From baseline to each post-treatment visit (up to 55 Weeks))
- Percentage of participants with ≥1-grade improvement on the ILA at rest at each post treatment visit(From baseline to each post-treatment visit (up to 55 Weeks))
- Percentage of participants satisfied with their facial appearance after the treatment as measured by a score of 'Very Satisfied' or 'Satisfied' on Subject's Level of Satisfaction (SLS)(From baseline to each post-treatment visit (up to 55 Weeks))
- Percentage of participants with change from baseline in psychological function, as measured by Psychological Well-Being Scale on FACE-Q(From baseline to each post-treatment visit (up to 55 Weeks))
- Percentage of participants with neutralising antibodies to corabotase(At screening, week 4, 12, 24, 36, 52)
- Time to onset of treatment response based on subject diary to evaluate the appearance of their lines(At baseline and daily from Day 1 to Day 8 (Week 1))
- Time taken for a responder to re-exhibit their baseline severity grade on the ILA at maximum frown(At all timepoints post-injection (Day 1) until end of study (up 55 Weeks))
- Time taken for a responder to re-exhibit a severity grade of 'Moderate' or 'Severe' as measured by the ILA at maximum frown(At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks))
- Percentage of participants experiencing treatment emergent adverse events (TEAEs) by severity and nature of TEAEs.(At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks))
- Percentage of participants experiencing serious adverse events (SAEs) by nature of SAEs(At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks))
- Percentage of participants experiencing Adverse Events (AEs) (or SAEs) leading to withdrawals, by severity and nature of these AEs.(At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks))
- Percentage of participants experiencing Adverse Events of Special Interest (AESIs), severity and nature of these AESIs(At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks))
- Percentage of participants with clinically significant changes from baseline in vital signs(At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks))
- Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination(At all timepoints post-injection (Day 1) until end of study (up to 55 Weeks))
研究者
研究点 (9)
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