EUCTR2005-005252-40-BE进行中（未招募）不适用
A Prospective Evaluation of BOTOX® and Dysport® in Temporal Brow Elevation - BOTOX® vs. Dysport® in Brow Lift
Aalst Dermatology Group0 个研究点目标入组 40 人开始时间: 2005年12月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female subjects of any race, between 18 and 65 years of age.
- •- Subjects who desire botulinum toxin type A injections for brow lift as a means to rejuvenate the upper face and who, in the opinion of the Investigator, will benefit cosmetically from such a procedure.
- •- Able to understand the requirements of the study and sign Informed Consent and Photography Release forms.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant (positive urine pregnancy test), are planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- •- Subjects planning a facial cosmetic procedure during the study period or with prior cosmetic procedures (i.e., surgery) or visible scars that may affect the evaluation of response and/or quality of photography.
- •- Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin
- •- Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.).
- •- Laser resurfacing, dermabrasion, or soft tissue augmentation in the frontal glabellar periocular area in the 12 months preceding Visit 1.
- •- Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function.
- •- Current use of aminoglycoside antibiotics, curare-like agents, or agents that might interfere with neuromuscular (skeletal) function.
- •- Profound atrophy/excessive weakness of muscles in target areas of injection.
- •- History of facial nerve palsy.
- •- Infection at the injection site or systemic infection (in this case, postpone study entry until one week following recovery).
- •- Allergy or sensitivity to any component of the study medication (Section 5.2).
- •- Previous botulinum toxin therapy of any serotype for any reason within six (6) months of the Baseline/Screening Visit.
- •- Evidence of recent alcohol or drug abuse.
- •- Medical and/or psychiatric problems that, in the Investigator’s opinion, are severe enough to interfere with the study results.
- •- History of poor cooperation, non-compliance with medical treatment, or unreliability.
- •- Participation in an investigational drug study within 30 days of the Baseline Visit.
研究者
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