Double-Blind, Randomized, Placebo-Controlled Study to Determine the Safety and the Efficacy of Using Botulinum Neurotoxin Type A Injections for Subjects With Mild to Moderate Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Mean Lesion Count From Baseline at 90 Days
研究概览
简要总结
• To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)
详细描述
• 90 day trial, with botox being injected at baseline/screening visit. Photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. Patient will complete a subject evaluation at each visit. Follow-up visits occur at Day 3, 7, 14, 30 and 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the age of 18 and 50 years of age
- •Not pregnant and negative pregnancy test, not planning on getting pregnant
- •Mild to moderate bilateral acne lesions on the face
- •Able to understand the requirements of the study and sign an Informed Consent Form
- •Have the time and ability to complete the study and comply with instructions(i.e will be around for the duration of the study)
- •Skin types I, II, III, IV and V
排除标准
- •Subject has skin type VI
- •Subject has a significant concurrent illness, such as diabetes, epilepsy, lupus or congestive heart disease
- •Concurrent skin conditions affecting area to be treated
- •Prior exposure to any serotype of botulinum toxin for any purpose in the 3 months immediately prior to study enrollment
- •Prior surgery on the area to be treated within 3 months of initial treatment or during this clinical evaluation
- •Open laceration, abrasion active cold sores or herpes sores, multiple dysplastic nevi in areas to be treated?
- •Permanent or semi-permanent dermal filler treatment within the last 6 months
- •Medium or deep depth chemical peel resurfacing procedure within 3 months of treatment or during this clinical evaluation
- •Has used oral isotretinoin (Accutane) within 6 months, or use of topical isotretinoin within 3 months, of initial treatment or during this clinical evaluation
- •Prior light /laser treatments at target locations within 3 months of enrollment or during the course of this clinical evaluation
- •Any physical or mental condition which, in the investigator's opinion would make it unsafe for the subject to participate in the clinical evaluation
- •Use of oral antibiotics for acne and/or medication that cause photosensitivity within 2 weeks of initial treatment
- •Participation in a study of another investigational devices or drugs within 3 months of enrollment
- •Subject shows symptoms of a hormonal disorder
- •Subject cannot be treated for (past or present) any form of treatment of active cancer or having a history of skin cancer or any other cancer in the area to be treated
- •Subject is currently using immunosuppressive medications
研究组 & 干预措施
Botox and Placebo on each side of face
Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)
干预措施: Botulinum Neurotoxin Type A (Drug)
Botox and Placebo on each side of face
Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)
干预措施: Bacteriostatic saline (Drug)
结局指标
主要结局
Change in Mean Lesion Count From Baseline at 90 Days
时间窗: Baseline and 90 days
To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)
次要结局
未报告次要终点
研究者
Steven H. Dayan
Medical Director
DeNova Research