The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Changes interincisal distance
研究概览
简要总结
This study will evaluate the use of botulinum toxin for microstomia (also known as reduced oral aperture) in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1-3. The study will include three arms: the temporomandibular joint (TMJ) group who will receive injections of Botox to the masseter, the perioral group who will receive injections of Botox around the lips, and a control group who will receive no treatment for ROA. Outcome measurements will include measurement of oral aperture size through measurement inter-labial distance and between the upper and lower lips and the inter-incisal distance, patient satisfaction via a Skindex16 survey, mouth disability via the Mouth Handicap in Systemic Sclerosis Scale (MHISS), and patient and physician satisfaction using the Visual Analogic Scale (VAS). The maximum number of subjects to be consented for this study is 30. The study is expected to last four months per subject from time of consent to last clinical evaluation. Conditions that may result in a subject exiting the study prior to completion date include non-compliance, withdrawal of consent, or safety concerns such as adverse events as a result of treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ddiagnosis of scleroderma (defined by the 2013 Classification Criteria for Systemic Sclerosis4,5)23,24 ) who also have microstomia (reduced oral aperture), defined as an inter-incisal distance less than 50 mm 6-7)m13,14 .
- •Male and female subjects.
- •English and non-English speakers.
- •Subjects aged 18 years old to 65 years old will be considered
- •Exclusion Criteria
- •Patients under 18 years old will be excluded.
- •Patients with a known history of a hypersensitivity to any Botox formulation or to any of the components in the formulation,
- •Active skin infection at the proposed injection site.
- •Concomitant neuromuscular disorder.
- •Pregnant or lactating.
- •Missing incisors.
- •treatment with: cyclophosphamide, Ultraviolet A-1 therapy, or topical calcitriol..
排除标准
- 未提供
结局指标
主要结局
Changes interincisal distance
时间窗: This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.
Interincisal distance is defined by the didistance between upper and lower incisor at maximum mouth opening. Distance will be measured using digital calipers by the same operator
Changes in inter-labial distance
时间窗: This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.
Inter-labial distance is defined as the distance between the upper and lower lip at maximum mouth opening. Distance will be measured using digital calipers by the same operator
quality of life via a Skindex16 survey
时间窗: This information will be collected at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.
This is a patient quality of life survey using the skindex 16 survey form.
次要结局
- Changes in the inter-commissural distance(This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.])
- Changes in the Mouth Handicap in Systemic Sclerosis Scale (MHISS)(This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.])
研究者
Heather Woodworth Goff
Associate Professor
University of Texas Southwestern Medical Center