NCT04886167进行中（未招募）1 期
A Dose-Ranging Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Platysmal Bands
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Investigator Live Assessment (Dynamic) - 1 month
研究概览
简要总结
This is a double-blinded, dose-ranging study in the US to assess the efficacy, safety, and duration of response of abobotulinumtoxinA for the treatment of moderate to severe platysmal bands.
详细描述
This study is intended to evaluate the efficacy and safety of an initial dose of 120 U, 180 U, and 240 U of abobotulinumtoxinA (with optional touch-up) in the treatment of moderate to severe platysmal bands. The platysmal bands will be treated by intramuscular injection of abobotulinumtoxinA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Male or female, 18 to 65 years of age.
- •Moderate to severe platysmal bands (grade 3 or 4 on the Photographic Platysma Bands Scale, which ranges from 1 [minimal] to 5 [extreme]) at rest and at maximum contraction as assessed by the Investigator Live Assessment (ILA).
- •Females of non-childbearing potential (i.e., post-menopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], or has undergone hysterectomy or bilateral oophorectomy) or
- •Females of childbearing potential with a negative urine pregnancy test at screening and baseline, and agrees to use a highly effective and approved contraceptive method for the duration of the study. A highly effective method of contraception is defined as:
- •Bilateral tubal ligation;
- •Combined (estrogen and progesterone containing) oral, intravaginal or transdermal contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit;
- •Intrauterine device (IUD) inserted at least 28 days prior to screening visit;
- •Intrauterine hormone-releasing system;
- •Partner vasectomized for at least three months prior to screening visit;
- •Progestogen -only oral, injectable or implantable contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit; or prior to screening visit; or
- •Strict abstinence (i.e., refraining from heterosexual intercourse for the entire duration of the subject's participation in the study).
- •Time and ability to complete the study and comply with instructions.
- •Understands the study requirements and signed the informed consent form (ICF).
排除标准
- •Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment.
- •Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
- •Known hypersensitivity to any component of the study product, or allergy to cow's milk protein* (according to the package insert/information).
- •*This criterion does not exclude subjects who are lactose intolerant. Lactose intolerance is a gastrointestinal disorder caused by an enzyme deficiency (lactase). An allergy to cow's milk protein is an immunological disorder that results in a systemic reaction, such as anaphylaxis.
- •Known allergy or sensitivity to any botulinum toxin serotype.
- •Female who is breast-feeding.
- •Female who intends to conceive a child during the study.
- •Current smoker of any kind (e.g., tobacco, cloves, marijuana, vape pens, hookah, etc.), and agrees not to smoke for the duration of the study.
- •Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck or chest within 12 months prior to study treatment.
- •Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, Poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck or chest within 24 months prior to study treatment.
- •History of lower face (i.e., below the level of the bottom of the nose), neck or chest surgery, aesthetic procedures (e.g. ablative skin resurfacing, laser, microneedling, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non- surgical fat reduction procedure) in the previous 12 months, or any other procedures which the Investigator's opinion would interfere with study evaluations.
- •Planned surgery or aesthetic procedures to the lower face (i.e., below the level of the bottom of the nose), neck or chest (e.g. ablative skin resurfacing, laser, mesotherapy, Platelet-Rich Plasma (PRP) treatment, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure) during the study period.
- •Clinically significant abnormal focused physical examination finding(s) at screening or baseline visits.
- •History of clavicular or sternal fracture.
- •Presence of inflammation, active infection or skin disorder, such as eczema, rosacea, psoriasis, pseudofolliculitis barbae, herpes zoster etc, near (i.e., superior to the clavicle and inferior to the mandible) or in the platysmal bands area.
- •History of neck pain, cervical disc degeneration, cervical dystonia, previous cervical neck surgeries, arm pain, numbness or weakness, asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, or breathing difficulties.
- •History or presence of cancerous or pre-cancerous lesions, or radiation near (i.e., superior to the clavicle and inferior to the mandible) or in the platysmal bands area.
- •Marked lower face (i.e., below the level of the bottom of the nose) or neck asymmetry, excessive neck skin or subcutaneous neck fat; excessive skin laxity, sagging, or banding; or deep horizontal neck folds.
- •Presence of scars, hair, or tattoos (facial, neck or chest) in the treatment area that may interfere with study evaluations.
- •History of bleeding disorder or current use of anticoagulant.
- •History or presence of any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Lambert-Eaton- syndrome, amyotrophic lateral sclerosis, voice disorders (aphonia, dysphonia, etc.), stroke, facial nerve palsy, or any other condition that might interfere with neuromuscular function.
- •Use of medications that affect neuromuscular transmission such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases, and aminoglycoside antibiotics.
- •Use of a muscle relaxant within 2 weeks prior to study treatment or planned use during the study.
- •Treatment with any investigational drug or device within 30 days prior to study treatment.
- •Any prior or current psychiatric illness (e.g. psychosis, depression, anxiety), alcohol or drug abuse, or is taking antidepressant, anxiolytic, or antipsychotic medication that, in the Investigator's opinion, could affect the subject's safety and/or the conduct or outcome of the study.
- •Other concurrent medical conditions, therapy or other condition that, in the Investigator's opinion, would interfere with the evaluation of the study medication safety or efficacy and/or put the subject at risk if he/she participates to the study.
- •Study center personnel, close relatives of the study center personnel (e.g. parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.
研究组 & 干预措施
120U abobotulinumtoxinA
Active Comparator
Treatment of platysmal bands using a total of 120 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.025mL (5 U).
At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 18 injection sites, with each injection site receiving 0.025mL (5 U).
干预措施: AbobotulinumtoxinA (Drug)
180U abobotulinumtoxinA
Active Comparator
Treatment of platysmal bands using a total of 180 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.0375mL (7.5 U).
At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.0375mL (7.5 U).
干预措施: AbobotulinumtoxinA (Drug)
240U abobotulinumtoxinA
Active Comparator
Treatment of platysmal bands using a total of 240 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.05mL (10 U).
At the 14 day visit, an optional touch-up using up to 120 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.05mL (10 U).
干预措施: AbobotulinumtoxinA (Drug)
结局指标
主要结局
Investigator Live Assessment (Dynamic) - 1 month
时间窗: 1 month
Responder rate at 1 month using the Investigator Live Assessment 5-point Photographic Scale at maximum contraction. The scale ranges from 1 to 5, with higher scores meaning a worse outcome.
次要结局
- Subject Self Assessment (Dynamic)(5 months)
- Investigator Live Assessment (At Rest)(5 months)
- Subject Self Assessment (At Rest)(5 months)
- Response Duration(5 months)
- Investigator Live Assessment (Dynamic)(5 months)
研究者
研究点 (1)
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