A Double Blinded Randomized Controlled Trial to Compare the Efficacy, Time to Onset, and Duration of Two Botulinum Type A Exotoxins (Onabotulinum Toxin A and Abobotulinum Toxin A) in the Treatment of "Crow's Feet."
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the time to onset of action, efficacy and duration of Dysport® versus Botox® Cosmetic in the treatment of lateral orbital rhytids.
研究概览
简要总结
The objective of the study is to compare the time to onset of Dysport® versus Botox® in the treatment of lateral orbital rhytids ("crow's feet"). Thirty subjects were enrolled in the study; specifically 30 male or female patients 18 years or older with moderate to severe lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated with Dysport® on one side and Botox® on the other side. Both the injector and patient were blinded to the injected toxin.
The efficacy endpoints were determined by investigator and subject live assessment of "crow's feet" at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 5 point photographic scale(no wrinkles [0], very fine wrinkles [1], fine wrinkles [2], moderate wrinkles [3] or severe wrinkles [4]) used in previous studies. A written description of each photograph was included to help standardize the application of the Photographic Scale.
详细描述
INTRODUCTION:
Dysport® (Medicis, Scottsdale, AZ) is the formulation (previously known as 52120 and Reloxin®) of Clostridium botulinum type A (BoNT-A) toxin-hemagglutinin complex to be used in the United States (US) cosmetic clinical program. It is identical to the Ipsen product marketed outside the United States and under clinical studies in the United States for cosmetic and non-cosmetic use. Dysport® injections are used to relax the musculature of the upper face, reducing the appearance of dynamic rhytids. Previously FDA-approved Botulinum type A toxins have been utilized in the upper face to treat glabellar rhytids for nearly two decades. Botox® Cosmetic (Allergan, Irvine, CA), is the first FDA-approved Botulinum toxin type A to be approved in the United States for the treatment of glabellar rhytids. Its efficacy and safety have been proven in multiple studies. However, no comparison to onset of action exists amongst the different BoNT-A products. This study seeks to compare the onset of action between two BoNT-A products, Dysport® and Botox® Cosmetic.
BACKGROUND:
Relaxation of facial musculature is routinely accomplished for cosmetic use by the use of Clostridium botulinum type A. Clostridium botulinum type A toxin reduces the recruitment of specific muscle groups. Many studies have been published in peer-reviewed medical journals regarding the cosmetic use of this biologic.2-11 Clostridium botulinum in the form of Botox® Cosmetic is FDA-approved for cosmetic use in the treatment of rhytids in the glabellar region. Dysport®, the brand name of the Ipsen product marketed outside the United States and under clinical studies in the United States for cosmetic and non-cosmetic use, and the current name now used under FDA-approval.
Many studies have demonstrated the effect of botulinum toxin on facial rhytids produced by underlying coordinated muscle groups. Those of the glabellar area, upper forehead, lower forehead, periocular and perinasal area are particularly well-documented. Previous reports of Dysport® and Botox® Cosmetic medications show effective relaxation of glabellar rhytids after injection.12-17
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients who meet all of the following criteria are eligible for this study:
- •Eighteen years of age or older.
- •Moderate to severe lateral orbital rhytids at maximum smile (score of [2] or [3] by physician assessment)
- •Negative pregnancy test for females of childbearing potential.
- •Time and ability to complete the study and comply with instructions.
- •Understanding of the study and contents of the informed consent.
排除标准
- •Patients who meet any of the following criteria are not eligible for this study:
- •Previous treatment to the glabellar area, forehead or lateral orbital rhytids with Dysport® or Botox® Cosmetic or other botulinum toxin within 180 days of entry into the study. Botulinum toxin treatment of areas other than the lateral orbital rhytids at any time during the study.
- •Patients with an ongoing treatment-related AE from any Dysport® or Botox® Cosmetic or botulinum toxin study.
- •Inability to substantially lessen lateral orbital lines by physically spreading them apart.
- •Permanent or semi-permanent dermal fillers in the lateral orbital rhytids at any time.
- •Ablative skin resurfacing on the lateral orbital rhytids at any time preceding the study or planning to during the current study.
- •Upper eyelid blepharoplasty or brow lift at any time preceding the study or planning to during the current study.
- •Non-ablative treatments in the lateral orbital region for skin dyschromias (e.g. Intense Pulsed Light, light-emitting diodes) at any time during the current study.
- •Non-ablative dermal treatment in the lateral orbital area for skin tightening (e.g. radiofrequency treatments at any time preceding the current study or planned to have this done during the current study.
- •Retinoid, microdermabrasion, or prescription-level glycolic acid treatments to the lateral orbital area within 2 weeks prior to study participation or during the current study.
- •Concurrent therapy that, in the investigator's opinion, would interfere with evaluation of the efficacy or safety of the medication.
- •Active infection of the lateral orbital area (e.g. acute acne lesions or ulcers).
- •Pregnant women, nursing mothers, or women who are planning pregnancy during the study, or think they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential must use reliable forms of contraception (e.g. abstinence, oral contraceptives for more than 12 consecutive weeks prior to enrollment, or spermicide and condoms).
- •Current history of chronic drug or alcohol abuse.
- •Enrollment in any active study involving the use of investigational devices or drugs.
- •Current facial palsy.
- •Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
- •Neuromuscular junctional disorders (myasthenia gravis).
- •Known allergy or hypersensitivity to any botulinum toxin or any component of Dysport® or Botox® Cosmetic.
- •Clinically diagnosed anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that, in the opinion of the investigator, might interfere with the patient's participation in the study.
- •Concurrent use of medications that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle, and aminoglycoside antibiotics.
- •Presence of any condition( e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function) or circumstance that, in the judgment of the investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
研究组 & 干预措施
Lateral orbital injection of Botox Cosmetic or Dysport
Lateral orbital injection of either Botox Cosmetic, 10 units or Dysport, 30 units as a single dose in a randomized (right or left sides) double blind fashion in 90 consecutive subjects
干预措施: Right lateral orbital injection of Botox Cosmetic or Dysport (Drug)
Lateral orbital injection of Botox Cosmetic or Dysport
Lateral orbital injection of either Botox Cosmetic, 10 units or Dysport, 30 units as a single dose in a randomized (right or left sides) double blind fashion in 90 consecutive subjects
干预措施: Left lateral orbital injection of Botox Cosmetic or Dysport (Drug)
结局指标
主要结局
To compare the time to onset of action, efficacy and duration of Dysport® versus Botox® Cosmetic in the treatment of lateral orbital rhytids.
时间窗: 9 months
Subject and investigator assessed grading as well as subject preference
次要结局
- To determine the safety and presence of any adverse effects of Dysport® (25 units) versus Botox® Cosmetic (10 units) in the treatment of lateral orbital rhytids.(9 months)
研究者
Corey S. Maas, M.D.
Director
The Maas Clinic