Effects of PrabotulinumtoxinA-xvfs on Facial Skin Quality, Fine Wrinkles, and Texture
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Scientific Assessment Scale of Skin Quality (SASSQ) Rating
研究概览
简要总结
The goal of this split-face clinical trial is to test the efficacy of microtox in improving facial skin quality, fine wrinkles, and texture. Participants will:
- be randomly assigned to Group A (which will receive 20 units of neuromodulator on the left side of the forehead and a placebo saline treatment on the right side) or Group B (which will receive 20 units of neuromodulator on the left side of the forehead and 20 units of a different neuromodulator brand on the right side as a comparator)
- have one treatment session at week 0, and two live assessment visits at weeks 2 and 12
- have their pictures taken at each visit to track progress
详细描述
Twenty (20) subjects will be enrolled in the study. The subjects will have one treatment session at week 0, and two live assessment visits at weeks 2 and 12. Office visits will last approximately 2 hours. All subjects will have their photographs taken at the beginning of each visit to track progress. Photographs will be taken of the forehead in a relaxed state, with eyebrows furrowed, and with eyebrows raised. All pictures will be taken via the Quantificare LifeViz Micro and will be stored via a HIPAA-compliant server.
Subjects will be randomly assigned to one of two groups. Group A will receive 10 units of prabotulinumtoxinA-xvfs delivered intramuscularly to the corrugator supercilii on the left of the glabellar lines, 10 units of prabotulinumtoxinA-xvfs delivered intradermally (~1 mm depth) to the left side of the forehead region, and a placebo saline treatment on the right side of the glabellar lines and forehead region. Group B will receive 10 units of prabotulinumtoxinA-xvfs delivered intramuscularly to the corrugator supercilii on the left of the glabellar lines, 10 units of prabotulinumtoxinA-xvfs delivered intradermally (~1 mm depth) to the left side of the forehead region, and 20 units of incobotulinumtoxinA on the right side (intramuscularly in the glabellar region and intradermally in the forehead region.
100 units of botulinum toxin A will be reconstituted with 5 mL of bacteriostatic saline. After subjects have their picture taken, topical Lidocaine/Tetracaine 23%/7% ointment cream will be applied to the treatment sites. After 15 minutes of numbing, the topical anesthetic will be cleaned off with alcohol. Subjects will be asked to repeatedly furrow and raise their eyebrows to let the treating physician assess the muscle of interest. With the subject in a semi-reclined position, the treating physician will inject microboluses using a standard 30 gauge 0.5" needle.
At each visit, the treating physician will rate each subject according to the Scientific Assessment Scale of Skin Quality (SASSQ). The Global Aesthetic Improvement Scale (GAIS) will be used by the treating physician and subjects to rate aesthetic improvement at each visit after baseline. Subjects will also rate their overall aesthetic improvement and treatment satisfaction at each visit after baseline according to a 5-point scale: (1) Extremely dissatisfied, (2) Dissatisfied, (3) Slightly satisfied, (4) Satisfied, (5) Extremely satisfied. Before and after photos of treated patients will be independently evaluated by the blinded, secondary evaluator using the SASSQ scale at each time interval of photos taken.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biological females, 18-65 years old, of any race and ethnic background
- •Individuals with mild to moderate facial wrinkles
- •All skin types (Fitzpatrick I-VI)
- •Willingness to participate and provide written informed consent
- •Ability to follow study instructions and likely to complete all required visits
排除标准
- •Females who are pregnant, breastfeeding, chronically using nonsteroidal anti-inflammatory drugs, have autoimmune conditions or have a known allergy to the study medications.
- •Previous cosmetic procedures near the forehead within the last 6 months or botulinum toxin treatments within the last 4 months
- •Known neuromuscular disorders or a hypersensitivity to botulinum toxin
- •Significant dermatological conditions affecting the face
- •Use of medications affecting neuromuscular function or skin healing within 2 weeks prior to the beginning of study
- •Subject has a condition or is in a situation which, in the opinion of the Investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.
研究组 & 干预措施
Treated with prabotulinumtoxinA-xvfs and placebo
Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and a placebo saline treatment will be injected into the right side of the subject's glabellar lines and forehead region.
干预措施: PrabotulinumtoxinA-Xvfs (Drug)
Treated with prabotulinumtoxinA-xvfs and placebo
Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and a placebo saline treatment will be injected into the right side of the subject's glabellar lines and forehead region.
干预措施: saline solution (placebo) (Drug)
Treated with prabotulinumtoxinA-xvfs and incobotulinumtoxinA
Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and approximately 20 units of incobotulinumtoxinA will be injected into the right side of the subject's glabellar lines and forehead region.
干预措施: PrabotulinumtoxinA-Xvfs (Drug)
Treated with prabotulinumtoxinA-xvfs and incobotulinumtoxinA
Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and approximately 20 units of incobotulinumtoxinA will be injected into the right side of the subject's glabellar lines and forehead region.
干预措施: IncobotulinumtoxinA (Drug)
结局指标
主要结局
Scientific Assessment Scale of Skin Quality (SASSQ) Rating
时间窗: Up to 12 weeks
The treating physician and the blinded, secondary evaluator will rate the subject after the final treatment. The scale identifies 6 parameters of skin quality: (1) loss of elasticity, (2) wrinkles, (3) roughness, (4) pigmentation/lentigines, (5) erythema, and (6) pore size. The scale has 5 points to describe the intensity of parameters 1-5: 0 implies none, 1 implies mild, 2 implies moderate, 3 implies severe, and 4 implies very severe. For parameter 6, 0 implies fine, 1 implies small, 2 implies moderate, 3 implies large, and 4 implies very large.
Global Aesthetic Improvement Scale (GAIS) Rating
时间窗: Up to 12 weeks
The treating physician and the blinded, secondary evaluator will rate the subject after the final treatment. Based on aesthetic appearance, qualitative success of treatment will be evaluated using the GAIS. Aesthetic appearance will be rated one of the five following options: - Worse: The appearance is worse than the original condition - No Change: The appearance is essentially the same as the original condition - Improved: Obvious improvement in appearance from the initial condition, but a touchup or re-treatment is indicated - Much Improved: Marked improvement in appearance but not completely optimal for this patient. A touchup would slightly improve the result - Very Much Improved: Optimal cosmetic result for the treatment in this patient.
次要结局
- Scientific Assessment Scale of Skin Quality (SASSQ) Rating(Up to 12 weeks)
- Global Aesthetic Improvement Scale (GAIS) Rating(Up to 12 weeks)
- Patient Satisfaction with Treatment and Aesthetic Appearance(Up to 12 weeks)
研究者
Kalpna Kay Durairaj, MD, FACS
Principal Investigator
K. Kay Durairaj, MD, FACS, A Medical Corporation