A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of AbobotulinumtoxinA (BTX-A) in Improving Forehead Wounds After Mohs Micrographic Surgery and Reconstruction for Skin Cancer
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
This study will test if the use of DysportTM (abobotulinumtoxinA) improves wound healing and scarring after Mohs surgery. Research in the laboratory as well as previous studies in humans have shown improved wound healing and scarring with the use of a similar medication called Botox.
Dysport may improve wound healing and scarring by relaxing facial muscles and therefore minimizes the muscle tension and possibly the inflammation around the wound.
详细描述
Primary Objective:
-To evaluate the efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS) at 6 weeks post surgery.
Secondary Objectives:
- To evaluate efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Patient and Observer Assessment Scale (POSAS) at week 1, 6, and 24.
- To evaluate the efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS) at week 1 and 24 post surgery.
- To evaluate patient satisfaction
- To evaluate safety (adverse events)
This is a 6 month, prospective, multicenter, double-blinded, randomized, placebo-controlled study. A total of 40 male or female healthy volunteers, 20 in each arm, will be enrolled. Up to 10 more patients can be enrolled to account for patient drop-out. Subjects will all undergo Mohs micrographic surgical removal of a skin cancer lesion on the forehead followed by reconstruction. Subjects will be randomized to receive either aboBTX-A injection or placebo injection in the frontalis, procerus, and corrugator muscles prior to reconstruction. Photographs, POSAS, and clinical assessments will be taken immediately after initial wound closure, at 1 week follow-up, at 6 weeks follow-up, and at 6 months follow-up. Adverse events will also be reviewed at each study visit. After the completion of the study, the photographs will be assessed (blinded as to the patient identifiers) using a 10 cm visual analog scale (VAS). The first few photographs will be evaluated by the surgeons together to calibrate the VAS and ensure inter-reliability.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment:
- •Ability to understand the risks, benefits, and alternative to participation and give informed consent
- •Have biopsy proven skin cancer on the medial forehead that is amenable to Mohs surgery. Medial forehead is defined as the area superiorly from the hairline, inferiorly at the eyebrow, and laterally to the tip of the lateral brow (see diagram).
- •Undergoing elective reconstruction of biopsy proven skin cancer that is amenable to Mohs surgery with defect size measuring 1.0 cm or greater
- •If female, not currently pregnant, no potential for pregnancy, or if of child-bearing age, must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for 30 days after the last dose of study drug. A negative urine pregnancy test is required at study entry for female subjects of childbearing potential: a woman is considered to be of child bearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oopherectomy, or is postmenopausal (without a menstrual period for at least one year)
- •Agrees to not use disallowed concomitant medications (retinoids)
排除标准
- •The presence of any of the following will exclude a patient from study enrollment.
- •Pregnant women, women who are breastfeeding, or women of child bearing age who are unwilling to use adequate contraception (described above) during the study period
- •Current or past history of a neuromuscular disease (such as myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)
- •Currently taking aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents)
- •History of radiation therapy or chemotherapy
- •History of keloid or other hypertrophic scar formation
- •Current or past history of scleroderma
- •Has used botulinum toxin in the forehead area within one year.
- •Has significant resting eyebrow ptosis
- •Has used any topical retinoids to the forehead area within the past 4 weeks
- •Undergo any scar revision procedure for the duration of the study including intralesional kenalog, laser treatment, and/or scar revision surgeries
- •Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein) or any previous hypersensitivity to any botulinum toxin A or related product.
- •Non-English speaking: These patients are excluded since translation of the informed consent into other languages is time-consuming and expensive as it requires a bona fide translator for the particular language of interest and this type of person may be difficult to locate.
- •House staff and students, medical students on a clerkship, and employees related to study personnel or who work for any study personnel, and members of the study team are not eligible to participate in this study as a subject.
- •The investigator feels that for any reason the subject is not eligible to participate in the study
研究组 & 干预措施
Dysport (abobotulinumtoxinA)
Each patient will be able to receive up to 120 units of Dysport/placebo at the initial visit to treat the entire forehead area (the frontalis, procerus, and corrugator muscles) to insure cosmetic symmetry. Injections will be placed a minimum of 1.5cm above the orbital rim at the mid papillary line to minimize the risk of lid ptosis. The actual amount to be injected will be at the discretion of the Mohs surgeon based on his or her opinion of what amount is needed for sufficient wound paralysis and cosmetic symmetry.
干预措施: Dysport (abobotulinumtoxinA) (Drug)
Placebo
干预措施: Bacteriostatic 0.9% Sodium Chloride (vehicle) (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 6 weeks post surgery
It consists of a 10 point scale to assess global scar assessment. Scar photographic images are assessed by independent physicians, and previous studies have shown very high intrarater consistency.
次要结局
- Patient and Observer Assessment Scale (POSAS)(at week 1, 6, and 24 post surgery)
- Visual Analogue Scale (VAS)(at week 1 and 24 post surgery)
研究者
Dr. Kevin Cooper
Principal Investigator
University Hospitals Cleveland Medical Center