NCT02249065已完成4 期
MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 205
- 试验地点
- 12
- 主要终点
- Pre-Treatment Clinician Erythema Assessment (CEA)
研究概览
简要总结
This study is designed to:
- assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel
- further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment
- gain a better understanding of the real-world use of Mirvaso® on the pattern and management of facial erythema of rosacea.
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
- 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
- 否
入选标准
- •Subjects must be 18 years of age or older at time of study consent.
- •Subjects with a board certified dermatologist (BCD) clinical diagnosis of facial erythema of rosacea and eligible for treatment with Mirvaso® (brimonidine) topical gel, 0.33% per package insert.
- •Subjects with a clinician's erythema assessment (CEA) score of ~3 at Screening Visit
- •Subjects with less than 3 facial inflammatory lesions of rosacea at Screening/Visit
- •Subjects must be willing and able to give written informed consent including photography consent. Consent and photo consent will be obtained prior to any study related procedures
- •Females of childbearing potential with a negative urine pregnancy test (UPT) at Visit 1 (prior to test article application) or females of non-childbearing potential (deemed as post-menopausal [absence of menstrual bleeding for at least 1 year prior to enrollment], hysterectomy or bilateral oophorectomy).
排除标准
- •Subjects with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
- •Subjects with current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjogren's syndrome or depression.
- •Subjects with previous refractive eye surgery such as photorefractive keratectomy, laser-assisted sub-epithelial keratectomy, or laser-assisted in situ keratomileusis.
- •Current treatment with monoamine oxidase inhibitors.
- •Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha- agonists.
- •Less than 3 months (90 days) stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
- •Subjects with any uncontrolled chronic or serious disease or medical condition that would normally prevent participation in a clinical study, or, in the judgment of the investigator, would put the subjects at undue risk, or might confound the study assessments (e.g., other dermatological diseases), or might interfere with the subjects' participation in the study, (e.g., planned hospitalization during the study).
- •Subjects who have received, applied, or taken treatments with drugs, cosmetics or devices known to cause facial erythema and who are deemed ineligible by the investigator.
- •Subjects with known allergies or sensitivities to any component of the study drug, including the active ingredient brimonidine tartrate label (refer to the package insert for Mirvaso® (brimonidine) topical gel, 0.33%).
- •Subjects with prior treatment with brimonidine gel, oxymetazoline or other (topical and/or systemic) alpha adrenergic agonists.
- •Subjects who are pregnant or breast-feeding or planning to become pregnant during the course of the study.
- •Subjects exposed to excessive ultraviolet (UV) radiation within I week prior to baseline and/or subject was unwilling to refrain from excessive exposure to UV radiation during the course of the study.
- •Subjects with the presence of a beard or excessive facial hair that would interfere with the study treatments or study assessments as deemed by the investigator, and refusal to remove beard or facial hair for duration of the study.
- •Subjects with non-stable dose of current (last 60 days) use of prescription rosacea medications.
- •Subjects with uncontrolled rosacea associated with inflammatory pustules and papules.
- •Study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.
- •Subjects with participation in any investigational study within 30 days of entry into this study or concomitantly with this study
研究组 & 干预措施
Mirvaso Gel
Experimental
Brimonidine topical gel, 0.33%
干预措施: Brimonidine (Drug)
结局指标
主要结局
Pre-Treatment Clinician Erythema Assessment (CEA)
时间窗: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)
The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.
次要结局
- Inflammatory Lesions(14 days (Day 1 (Baseline) and Day 14/Exit))
- Facial Redness Visual Analog Scale (VAS)(14 days (Day 1 (Baseline), Day 14/Exit))
- Subject Facial Redness Questionnaire(14 days (Day 1 (Baseline) and Day 14/Exit))
- Subject Treatment Satisfaction Questionnaire(14 days (Day 14/Exit))
研究者
研究点 (12)
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