Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 主要终点
- Efficacy Assessments for Flushing
研究概览
简要总结
To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.
详细描述
To assess the improvement of facial erythema and flushing while using Mirvaso® and Dysport® treatments based on the clinician's and patient's assessments using a verified 5-point grading scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female
- •18 years of age or older
- •Clinical diagnosis of rosacea
- •Moderate to severe persistent facial erythema associated with rosacea at baseline, as determined by: a grade of greater than or equal to 3 on the 5 point grading scale1 (Figure 1)
- •No known medical conditions that may interfere with study participation
- •Willingness to not use any products on their face for the duration of the study
- •Read, understand, and sign informed consent forms
- •Willingness to sign photography release form
- •Willing and able to comply with all follow-up requirements
- •Willingness to undergo treatment using Mirvaso® Gel and Dysport®
排除标准
- •Any significant skin disease at treatment area
- •Any medical condition which could interfere with the treatment
- •Inability or unwillingness to follow the treatment schedule
- •Inability or unwillingness to sign the informed consent
- •Pregnant or lactating
- •Allergy to cow's milk protein
- •Previous or current use of Mirvaso® Gel
- •Known hypersensitivity to Dysport® , Mirvaso® Gel or any of their ingredients
- •Previous Dysport® treatment 6 months prior to the screening visit
研究组 & 干预措施
Dysport® in conjunction with Mirvaso
Dysport® in conjunction with Mirvaso
干预措施: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33% (Drug)
Mirvaso® (brimonidine) topical gel, 0.33%
Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older.
干预措施: Mirvaso® (brimonidine) topical gel, 0.33% (Drug)
Dysport®
Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
干预措施: Dysport® (Drug)
结局指标
主要结局
Efficacy Assessments for Flushing
时间窗: 6 months
% of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Flushing 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Flushing on the 5-point grading scale.
Efficacy Assessments for Erythema
时间窗: 6 months
% of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Erythema 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Erythema on the 5-point grading scale.
次要结局
- Safety Assessments(6 months)
研究者
David J. Goldberg, MD
Principal Investigator
Skin Laser & Surgery Specialists