Evaluation of Different Doses of Botulinum Toxin Type A for the Treatment of Gummy Smile
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduction of the upper gum exposure at 4 weeks and 12 weeks.
研究概览
简要总结
This is a two part study to measure and observe the efficacy of botulinum toxin A for the treatment of gummy smiles.
Part A will randomly compare three different doses of botulinum toxin type A (abobotulinumtoxin A) for the treatment of upper anterior gummy smile with larger gingival exposure (> 4 mm).
Part B will assign one of two doses of botulinum toxin type A for participants with smaller gingival exposure (< 4 mm).
Follow-up visits with photography will occur 4 and 12 weeks after their treatment. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
This study is a pilot study designed to determine feasibility of this procedure.
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
- Single (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
- •Written informed consent
- •Males or females ≥ 18 years old
- •Anterior gingival exposure during smiling larger than 4 mm measured from the central incisor tooth (part A), or 2-4 mm (part B).
- •Subjects of childbearing potential who present a negative urine pregnancy test at baseline and use an effective contraceptive method.
- •Subjects are in good health as judged by the investigator.
- •Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
排除标准
- •Pregnant women or women intending to become pregnant in the next 8 months after the screening for eligibility
- •Subjects participating in other clinical trials
- •Any prior surgery affecting the area of study
- •Subjects with neoplastic, muscular or neurological disease
- •Subjects who have received botulinum toxin treatment for gummy smile in the previous 12 months before the inclusion date
- •Subjects who have received Botulinum toxin treatment for any other cosmetic indication in the previous 6 months before the inclusion date
- •Subjects using aminoglycosides and penicillamine antibiotics, quinine or calcium channel blockers
- •Subjects with inflammation or active infection in the area to be injected
- •Subjects with history of sensitivity to the components of the formulation.
- •Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- •Subjects who are unable to understand the protocol or give informed consent.
研究组 & 干预措施
2.5 U dose
Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows:
- 2.5 U
- 5 U
- 7.5 U
干预措施: Botulinum toxin type A (Drug)
5 U dose
Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows:
- 2.5 U
- 5 U
- 7.5 U
干预措施: Botulinum toxin type A (Drug)
7.5 U dose
Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows:
- 2.5 U
- 5 U
- 7.5 U
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Reduction of the upper gum exposure at 4 weeks and 12 weeks.
时间窗: [Baseline, 4 weeks,12 weeks]
Reduction in millimeters in the upper gum exposure of subjects after botulinum toxin type A (abobotulinumtoxin A) treatment.
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Northwestern University