An Open-Label Pilot Study to Compare the Efficacy of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids
试验速览
- 阶段
- 4 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Efficacy of escalating doses of Xeomin® in the treatment of glabellar rhytids
研究概览
简要总结
The objective of the study is to compare the efficacy and duration of escalating doses of IncobotulinumtoxinA (Xeomin®) in the treatment of glabellar rhytids (frown lines between the eyes). Fifteen subjects will be enrolled in the study; specifically 60 male or female patients 18 years of age or older with moderate to severe glabellar rhytids at maximum contracture. Each patient will be randomized to receive one of 5 doses of Xeomin®, in a one-time dose to the treatment area.
The efficacy endpoints will be determined by investigator and subject live assessment of the glabellar rhytids 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 4 point photographic scale (minimal wrinkles [0], mild wrinkles [1], moderate wrinkles [2], or severe wrinkles [3]) used in previous studies. A written description of each photograph will be included to help standardize the application of the Photographic Scale.
详细描述
Introduction 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. Approximately two years ago, Dysport® (Medicis, Scottsdale, AZ) also received FDA approval for the treatment of dynamic glabellar rhytids. While both products have been on the market in Europe for over two decades, they have only been used in the United States for cosmetic applications for the past ten years. Xeomin® (Merz Pharmaceuticals, Frankfurt, Germany), at first, obtained FDA approval for the treatment of cervical dystonia and blepharospasm - two applications which the previous two botulinum type A toxins (onabotulinumtoxinA and abobotulinumtoxinA) had initially received prior to cosmetic approval. More recently, Xeomin® has been approved for cosmetic use. This study aims to assess the efficacy of varying doses of incobotulinumtoxinA in the treatment of glabellar rhytids.
Background Cosmetic procedures have been in increasing demand to reverse the appearance of advancing age, particularly procedures that improve the appearance of the aging face. Noninvasive procedures with little to no downtime that offer significant improvement to the aging appearance of the skin and underlying musculature are often preferred procedures to surgical options. Although no procedure is entirely risk free, continuing research is required to provide a safe and efficacious approach to aesthetic procedures for treating the aging face.
Although there are five factors that contribute to the appearance of the aging face,1 there are two anatomical units that most influence the appearance of facial rhytids: the skin and its underlying musculature. Many therapies have evolved to treat rhytids including resurfacing, topical preparations, soft tissue injectable fillers, and lastly, botulinum toxin.
Relaxation of facial musculature is routinely accomplished for cosmetic use by the use of Clostridium botulinum type A (BoNT-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 (onabotulinumtoxinA) is FDA-approved for cosmetic use in the treatment of rhytids in the glabellar region. Dysport® (abobotulinumtoxinA) has been used similarly to treat the glabellar region received FDA approval in 2009. Xeomin® (incobotulinumtoxinA) received FDA approval in October 2010 for the treatment of cervical dystonia and blepharospasm, and has been used globally since 2005. Several studies have noted its efficacy in these clinical applications.12-16 More recently, Xeomin® (incobotulinumtoxinA) obtained FDA approval in July 2011 for cosmetic use. Its maker employs a manufacturing process which has isolated the active protein and eliminated accessory proteins present in other formulations.
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
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 vertical glabellar lines at maximum frown (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 with Dysport® or Botox® Cosmetic or other botulinum toxin within 90 days of entry into the study. Botulinum toxin treatment of areas other than the glabellar area 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 glabellar lines by physically spreading them apart.
- •Soft tissue augmentation of the glabellar area (e.g. collagen-type implants, or hyaluronic acid fillers) at any time during the current study.
- •Permanent or semi-permanent dermal fillers in the glabellar area at any time.
- •Ablative skin resurfacing on the glabellar area 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 glabellar area for skin dyschromias (e.g. Intense Pulsed Light, light-emitting diodes) at any time during the current study.
- •Non-ablative dermal treatment in the glabellar area for skin tightening (e.g. radiofrequency treatments at any time preceding the current study or plan to have this done during the current study)
- •Retinoid, microdermabrasion, or prescription-level glycolic acid treatments to the glabellar 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 glabellar 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.
结局指标
主要结局
Efficacy of escalating doses of Xeomin® in the treatment of glabellar rhytids
时间窗: 12 months
Investigator and subject assessed grading
次要结局
- Duration of action of escalating doses of Xeomin® in the treatment of glabellar rhytids(12 months)
- Safety and presence of any adverse effects of Xeomin® in the treatment of glabellar rhytids(12 months)
研究者
Corey S. Maas, M.D.
Director
The Maas Clinic