A Phase I/III, Randomized, Two-armed, Double-blinded, Parallel, Active-controlled, Non-inferiority Clinical Trial to Compare Efficacy and Safety of AbobotulinumtoxinA (Espad Pharmed) Versus AbobotulinumtoxinA (Dysport®, Ipsen Co.) for Correction of Moderate to Severe Glabellar Lines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Responders at maximum frown by investigator's assessment
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) for correction of moderate to severe glabellar lines.
Hypothesis: AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) has acceptable efficacy and safety profile for correction of moderate to severe glabellar lines.
Primary Outcome: To verify the non-inferiority of the efficacy of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) compared with AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.) by percentage of responders at maximum frown at day 30 after treatment.
Researchers will compare the efficacy and safety profile of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) with AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.).
The study is designed as phase III, randomized, two armed, double-blind, parallel, active controlled, non-inferiority clinical trial.
Participants received a total dose of 40-60 units into 3 to 5 sites. After two weeks, a touch-up intervention could be done based on physician's assessment.
详细描述
The study schedule includes Visit 0 (Screening), Visit 1 (Intervention, Day 0), and Follow-up Visits 2 (Day 14), 3 (Day 30), 4 (Day 90), and 5 (Day 120). At Visit 0, informed consent is obtained, and eligibility is assessed through initial evaluations and review of inclusion and exclusion criteria. At Visit 1, subjects are randomized (1:1) and receive the investigational treatment. Full-face photographs are obtained at Visit 1 (Before receiving the investigational treatment), and at Follow-up Visits 2, 3, 4, and 5, in both resting state and maximum frown. Efficacy is evaluated at Visits 3, 4, and 5. All adverse events are Recorded at all visits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 to ≤65 years of age
- •Willingness for signing and having signed the informed consent form
- •Moderate to severe glabellar wrinkle at maximum frown based on glabellar lines severity scale (GLSS)
- •be able to participate in the visit schedules and the study procedures.
排除标准
- •Hypersensitivity to botulinum toxin or any other component of the formulation, as well as to injectable fillers in the facial region.
- •Previous treatment with botulinum toxin in facial areas within the past 6 months.
- •Previous treatment with dermal fillers, dermabrasion, or photo rejuvenation in the glabellar region within the past 12 months.
- •History of dermal filler injection in the forehead region within the past year.
- •History of eyebrow tattooing or any other procedure involving the eyebrow area within the past month.
- •Use of aminoglycosides, penicillamine, quinine, chloroquine, hydroxychloroquine, or calcium channel blockers within the past week.
- •Use of anticoagulants or aspirin within the past 10 days (participants are not required to discontinue their anticoagulant therapy to be enrolled in the study).
- •History of any cosmetic surgery (e.g., filler injections, chemical peels, or laser treatments) or use of products that induce skin remodeling or significantly affect the forehead area or its surroundings, including any aesthetic procedure involving the glabellar lines within the past 6 months.
- •History of any surgical procedure involving facial muscles or scarring in the forehead or surrounding areas (including the eyebrows).
- •Any planned aesthetic procedure involving the upper face during the course of the study.
- •Presence of disorders that may affect neuromuscular function (e.g., myasthenia gravis, amyotrophic lateral sclerosis [ALS], or Eaton-Lambert syndrome).
- •History of facial nerve paralysis.
- •Presence of clearly visible and defined facial asymmetry.
- •Ptosis of the eyelids or eyebrows due to facial muscle paralysis or a history thereof.
- •Presence of any active infection or acute dermatological condition in the injection areas.
- •Pregnancy (confirmed by urine test) or lactation.
- •Participation in other clinical studies within 30 days prior to randomization or intention to participate in other clinical trials.
- •Any other condition or circumstance that may pose a risk to the participant or interfere with the satisfactory completion of the clinical outcome.
- •History of participation in other clinical trials involving botulinum neurotoxin products or fillers within the past 6 months.
研究组 & 干预措施
Abobotulinumtoxin A (produced by Espad Pharmed Darou Co.)
Vial of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.), administered via deep intramuscular injection into 3 to 5 sites in the glabellar area using a 1 ml syringe, with a total dose of 40 to 60 International Units (IU), administered in a single treatment session.
干预措施: Abobotulinumtoxin A (Espad Pharmed Darou Co.) (Drug)
Abobotulinumtoxin A (Dysport®, produced by Ipsen Co.)
Vial of AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.), administered via deep intramuscular injection into 3 to 5 sites in the glabellar area using a 1 ml syringe, with a total dose of 40 to 60 International Units (IU), administered in a single treatment session.
干预措施: Abobotulinumtoxin A (Ipsen Co.) (Drug)
结局指标
主要结局
Responders at maximum frown by investigator's assessment
时间窗: Day 30
Percentage of responders measured by the investigator's live assessment based on Glabellar Line Severity Scale (GLSS) at maximum frown at day 30 after treatment The Glabellar Line Severity Scale (GLSS) is a 4-grade scale defined as follows: 0 = no glabellar lines, 1 = mild lines, 2 = moderate lines, 3 = severe lines. Higher scores indicate more severe glabellar lines. Participants were considered responders if they showed a reduction of at least 2 points from baseline on the scale.
次要结局
- Responders at rest by investigator's assessment(Days 30, 90 and 120)
- Responders at maximum frown by subject's self-assessment(days 30, 90 and 120)
- Responders at rest by subject's self-assessment(days 30, 90 and 120)
- Responders at maximum frown by investigator's assessment(days 90 and 120)
- Total injected dose (visit 1 and touch-up visit)(Day 14)
- Onset of action measured by the subject's self-assessment (SSA) at rest(Day 14)
- Onset of action measured by the subject's self-assessment (SSA) at maximum frown(Day 14)
- Safety assessment by evaluation of adverse events (AEs)(Visit 0 (screening), visit 1 (Day 0), visit 2 (Day 14), visit 3 (Day 30), visit 4 (Day 90), visit 5 (Day 120))