A Multi Center Prospective Single Arm Post Market Surveillance Study to Evaluate the Safety and Efficacy of Botulinum Toxin Type A in Management of Moderate to Severe Facial Wrinkles
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- To assess the safety of Botulinum Toxin Type A
研究概览
简要总结
This study is a Multi-Center, Prospective, Single Arm, Post Market Surveillance Study to Evaluate the Safety & Efficacy of Botulinum Toxin Type A in Management of Moderate to Severe Facial Wrinkles for Four months (120 days) in 100 patients with severe facial wrinkles. Subjects will complete a screening visit (V1) to determine eligibility for the study based on Inclusion & Exclusion Criteria, medical history and safety measures. The primary end point is Evaluation of safety will include assessment of safety of the formulation with respect to adverse events. Evaluation of efficacy will include: Proportion of subjects reported by the investigator at least ‘improved’ on ‘Modified Global Aesthetic Improvement Scale (GAIS)’ at the end of study visit, Proportion of subjects self-reported at least ‘improved’ on ‘Modified Global Aesthetic Improvement Scale (GAIS)at the end of study visit, Comparison of subject’s Self-perception of age will be done between baseline and end of study visit. The rating will be reported as I look my current age, I look _ years younger, or I look _ years older.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male/Femles of 30-50 years of age 2) Subject who can and willing to provide written informed conscent 3)Subjects motivated and aesthetically conscious with moderate to severe facial wrinkles 4)Females of child bearing potential must have negative urine pregnancy test, must be practicing a medically acceptable method of birth control and not lactating.
排除标准
- •Subjects with a known severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies 2) Subjects with a known allergy or sensitivity to any of the study medication or their components 3) Subjects having a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol 4) Subjects has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration 5) Subjects with a history of vision loss not corrected by lenses, or LASIX surgery, glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease 6) Subjects with acute infection
- •Subject with myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function 8) Concurrent use of aminoglycoside antibiotics that interfere with neuromuscular function 9) Subjects with history of previous injection of botulinum Toxin within eight months 10) Subjects with severe thin skin in treatment area as determined by the investigator 11) Subjects with infection at the injection site 12) Subjects having received anticoagulation, anti-platelet and thrombolytic treatment (eg Warfarin), anti-inflammatory drugs (NSAIDs aspirin, Ibuprofen, etc) or any other substance known to increase the coagulation time from 10 days pre to 3 days post injection.
结局指标
主要结局
To assess the safety of Botulinum Toxin Type A
时间窗: 4 Months
次要结局
- Evaluation of efficacy(4 months)