A Single Center, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA to the Depressor Anguli Oris
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- One grade improvement on Depressor Anguli Oris Scale
研究概览
简要总结
Single Center, Double Blind, Placebo- Controlled Study of 20 subjects with 10 active drug/10 placebo
Standardized baseline/pre-treatments and follow-up images will be taken.
Subjects will receive injection of either study drug or placebo to the Depressor Anguli Oris. Follow ups will occur at 2 weeks, 4 weeks, and 12 weeks.
详细描述
- This study is a prospective single-center, clinical trial to be conducted at one clinical site. Up to 20 subjects will be enrolled and treated (total enrollment may be more than 20 due to screen failures) if they meet the inclusion/exclusion criteria and provide written informed consent.
- Duration of Study The duration from when the study opens to enrollment until completion of data analysis is anticipated to be six months
- Study Endpoints 3.1 Primary Endpoint: One grade improvement on Depressor Anguli Oris Scale as assessed by the Principal Investigator
Depressor Anguli Oris Scale
0-None Slight or no muscle contraction
- Mild Mild contraction with mild pull down of corner of the mouth
- Moderate Moderate muscle contraction and moderate pull down of corner of mouth
- Severe Severe Muscle contraction with sever pull down of corner of the mouth
3.2 Secondary Endpoints
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
- •Male or non-pregnant, non-breastfeeding females
- •Age ranging between 18-65
- •Subject seeking augmentation therapy of the depressor anguli oris.
- •Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the horizontal line from the sub nasal for the duration of the study. (e.g. laser or chemical peels, skin resurfacing, microdermabrasion, etc.)
- •If the subject is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test at the screening/enrollment visit and prior to treatment.
- •Acceptable forms of effective birth control include:
- •Barrier methods of contraception: Condom or Occlusive cap
- •(diaphragm or cervical caps) with spermicidal foam/gel/film/cream/suppository;
- •Bilateral tubal ligation;
- •Combined oral contraceptives (estrogens and progesterone), implanted or Injectable contraceptives on a stable dose for at least 28 days prior to Day 1;
- •Hormonal or copper intra uterine device (IUD) inserted at least 28 days prior to Day 1;
- •Vasectomized partner (in monogamous relationship) for at least 3 months prior to screening;
- •Strict abstinence (at least one month prior to baseline and agrees to continue for the duration of the study or use acceptable form of birth control). Negative urine pregnancy test at screening.
- •Subjects willing to provide written consent for use of photography -
排除标准
- •History of other facial treatment/procedure in the previous 6 months below the level of the horizontal line from sub nasal that, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessments or exposes the subject to undue risk by study participation.
- •Presence of any disease or lesions near or on the area to be treated:
- •Inflammation, active or chronic infection (e.g., in mouth, dentals, head and neck region);
- •Facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes simplex or herpes zoster;
- •Scars or deformities
研究组 & 干预措施
Active- onabotulinumtoxinA
BOTOX Cosmetic (onabotulinumtoxinA) for injection, is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
干预措施: OnabotulinumtoxinA 50 UNT [Botox Cosmetic] (Drug)
Placebo-Bacteriostatic 0.9% Sodium Chloride
Placebo subjects will have injections in the same manner, but will be injected with Bacteriostatic 0.9% Sodium Chloride.
干预措施: OnabotulinumtoxinA 50 UNT [Botox Cosmetic] (Drug)
结局指标
主要结局
One grade improvement on Depressor Anguli Oris Scale
时间窗: 2 weeks Post Treatment
The scale will be used to measure if the subject has had any grade improvement in the treated area since baseline. Scale measures the severity of the depressor Anguli Oris from a 0-none-3 Severe as explained in the Detailed description section 3
次要结局
- Improvement on Investigator Global Aesthetic Improvement Scale(2 weeks Post Treatment)
- Patient Satisfaction Questionnaire(2 weeks Post Treatment)
- Photographic Analysis(2 weeks Post Treatment)
- Improvement on Subject Global Aesthetic Scale(2 weeks Post Treatment)
- Safety Assessments such as Focused Physical & adverse event, or expected treatment effects(12 weeks Post Treatment)
研究者
Amir Moradi MD, MBA
Principal Investigator
Moradi MD