CTRI/2018/11/016357已完成4 期
A prospective, Phase IV, multi-center, open label, Single dose clinical study to demonstrate the safety and efficacy of DYSPORT® in adult subjects for treatment of moderate-to-severe glabellar lines
Cliniexperts Services Private Limited0 个研究点目标入组 105 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Subjects is an adult, of at least 18-65 years of age
- •2.Subject has grade 2-3 moderate to severe glabellar lines at maximum frown as assessed by the investigator using 4-point photographic glabellar line severity scale (GLSS)
- •3.Subject is willing and able to complete the entire course of the study as per the study protocol.
- •4.Subject is able to provide informed consent and comply with study instructions
排除标准
- •1.Previous treatment with botulinum toxin of any serotype in any area within the last 6 months.
- •2.Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
- •3.Previous insertion of permanent material in the glabellar area
- •4.Planned treatment with botulinum toxin of any serotype in any other body region during the study period
- •5.Any surgery in the glabellar area including surgical removal of the corrugators, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
- •6.Energy-based or cryo-therapy based treatment of facial muscles superior to the lateral canthus
- •7.Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine)
- •8.Marked facial asymmetry
- •9. Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.
- •10.History of facial nerve palsy
- •11.Subjects with previous or current diagnosis of Bellâ??s paresis.
- •12.Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants.
- •13. Subjects who are taking anticholinergics or aminoglycoside antibiotics.
- •14.Subjects with active inflammation or infection in the areas to be treated.
- •15. Subjects with history of any other adverse effect, which should prevent the subject from participating in the study according to the investigatorâ??s opinion.
- •16. Subjects who are study site staff for this study, or close relatives of the study site staff, as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company.
- •17.14. Other condition preventing the subject from entering the study in the investigatorâ??s opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
- •18.Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin
- •19.Any active infection in the area of the injection sites
- •20.Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
- •21.Evidence of recent alcohol or drug abuse
- •22.Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
- •23.Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception in next 12 months.
- •24.Known allergy or hypersensitivity to botulinum toxin preparation
- •25.Participation in another interventional clinical study within the last 30 days
研究者
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