Phase Iv Study On The Safety And Efficacy Of The Full Face Applications Of Variable Doses Of 125 To 250 Units Of A Commercial Botulinum Toxin Type A (Dysport®)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Wrinkles' Severity (Periocular [Crow's Feet])
研究概览
简要总结
This is an open-label and phase IV study of full face injections of variable doses of botulinum toxin type A (BT-A). As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Each group will receive a specific dose according with the indication evaluated by the investigator. Six visits will be schedule in this study.
详细描述
4.2 Methodology
4.2.1 Patient evaluation After providing written informed consent, subject's eligibility will be assessed at a Screening Visit. The subject's general medical history will be recorded. This includes demographic data, history of surgical and cosmetic procedures, dermatological assessment, physical examination, and prior concomitant medications. A pregnancy test will also be performed.
4.2.1.1 Severity of wrinkles
One sub-investigator will rate the wrinkles with the following validated severity scales for the main areas of the face at Baseline, Week 4, Week 8, Week 16 and Week 24:
- Clinical 0-3 score for standardized assessment of facial wrinkles in the glabella area (from GLADYS study)
- Photometric Atlas for the Assessment of Crow's Feet Severity
- Facial Wrinkle Scale, for forehead lines (Carruthers A, et al. Dermatol Surg. 2003;29(5):461-7)
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
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written Informed Consent;
- •Subjects aged between 30 and 60 years;
- •Skin Fitzpatrick Phototypes I to VI;
- •Subjects that never received BT-A or who had previous injections of BT-A in no more than one third of the face with in the last 6 months;
- •Subjects presenting at least two indications for treatment with BT-A in each third of the face;
- •Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;
- •Subjects of childbearing age should present a negative urine pregnancy test (instant test) at baseline and should be using an effective contraceptive method (oral or injectable contraceptive, for at last three months, and use of preservative; subjects with: hysterectomy, oophorectomy or tubal ligation);
- •Availability of the patient throughout the duration of the study (24 weeks);
- •Subjects that agree not to undergo other cosmetic or dermatological procedures during the study;
- •Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by the study protocol.
排除标准
- •Pregnant women or women intending to become pregnant during the study;
- •Subjects participating in other clinical trials;
- •Presence of scars on the face that may interfere with the result of study;
- •Subjects with neoplastic, muscular or neurological diseases;
- •Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics.
- •Subjects with inflammation or active infection in the face;
- •Subjects with a history of sensitivity to the components of the formula;
- •Subjects with prior history of eyelid ptosis; marked facial asymmetry, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
- •Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases;
- •Subjects with coagulation disorders or using anticoagulants;
- •Subjects with known systemic autoimmune diseases;
- •Subjects clinically diagnosed anxiety disorder or any significant psychiatric disorder (e.g. depression) that, in the opinion of the Evaluator, might interfere with the Subject's participation in the study;
- •Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol.
研究组 & 干预措施
125 to 170 IU of "'Botulinum toxin' "
group with intervention of 125 to 170 IU of 'Botulinum toxin'
干预措施: Botulinum toxin (Drug)
171 to 210 IU of 'Botulinum toxin'
Patients who have received 171 to 210 IU of 'Botulinum toxin'
干预措施: Botulinum toxin (Drug)
211 to 250 IU of Botulinum toxin
Patients who have received 211 to 250 U of Botulinum toxi'
干预措施: Botulinum toxin (Drug)
结局指标
主要结局
Wrinkles' Severity (Periocular [Crow's Feet])
时间窗: Baseline; Week 4; Week 16; Week 20; Week 24
Photonumeric Atlas for the Assessment of Crow's Feet Severity: 0 - none, 1 - mild; 2 - moderate; 3 - severe
Wrinkles' Severity (Glabella)
时间窗: Baseline; Week 4; Week 16; Week 20; Week 24
GLADYS study Atlas: 0 - no wrinkles, 1 - mild wrinkles; 2 - moderate wrinkles; 3 - severe wrinkles
Wrinkles' Severity (Forehead)
时间窗: Baseline; Week 4; Week 16; Week 20; Week 24
Facial Wrinkle Scale: 0 - none, 1 - mild; 2 - moderate; 3 - severe
次要结局
未报告次要终点
研究者
Doris Hexsel
MD
Brazilan Center for Studies in Dermatology