NCT01451619已完成1 期
A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Assess the Pharmacodynamics of MK-0524 in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea. (Protocol No. 155)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline
研究概览
简要总结
This study will assess the effect of MK-0524 relative to placebo, on signs and symptoms of rosacea and to determine the safety and tolerability profile of MK-0524 in participants with rosacea.
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
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
- •Moderate to severe erythematotelangiectatic rosacea with moderate to severe erythema of facial lesion
- •Generally healthy excluding rosacea
- •Presence of telangiectasia
- •Five or less facial inflammatory lesions
- •Able to restrict diet in order to avoid foods/drinks (including alcohol) that are known to exacerbate the signs/symptoms of rosacea
- •Females of childbearing potential must have negative serum pregnancy test and agree to use one form of contraception
排除标准
- •Diagnosis of skin disorders, including psoriasis, acne vulgaris, perioral dermatitis or atopic dermatitis that would interfere with the clinical evaluations of rosacea
- •Using and unable to discontinue use of phosphodiesterase (PDE) 4 inhibitors, theophylline, niacin greater than 500 mg/day
- •Known or suspected excessive alcohol intake
- •Sensitivity to tetracyclines
- •Ocular rosacea and/or blepharitis/meibomianitis
- •Pregnant or breastfeeding
- •Perimenopausal and has symptoms that cause flushing that may affect rosacea
- •Initiated hormonal method of birth contraception within 4 months of baseline, discontinues use during the course of the study, or changes hormonal method within 4 months
- •Active mycobacterial infection of any species within 3 years
- •History of mycobacterium tuberculosis infection
- •History of recurrent bacterial infection
- •Congenital or acquired immunodeficiency common variable immunodeficiency (CVID), Hepatitis B surface antigen positive or Hepatitis B core antibody positive
- •Human immunodeficiency virus (HIV) infection
- •Positive for hepatitis C antibodies
- •Malignancy or has had a history of malignancy greater than 3 years prior
- •Will continue to use any of the following treatments during the study: Systemic retinoids, therapeutic vitamin A supplements of greater than 10,000 units/day, systemic steroids, systemic antibiotics known to have an impact on the severity of facial rosacea, systemic treatment for acne, topical steroids, topical retinoids, topical acne treatments including prescription and over-the-counter (OTC) preparations, topical anti-inflammatory agents, topical antibiotics, topical imidazole antimycotics, cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy, pulse-dye laser, intense pulse light, astringents, abrasives, benzoyl peroxide products, sulfur containing washes, eye washes, Beta blockers, vasodilators, vasoconstrictors and/or chronic use (>14 days) of topical or systemic anti-inflammatory agents
研究组 & 干预措施
Laropiprant
Experimental
干预措施: Laropiprant (Drug)
Placebo
Placebo Comparator
干预措施: Placebo for Laropiprant (Drug)
结局指标
主要结局
Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline
时间窗: Baseline and Week 4
次要结局
- Change in Patient Self Assessment (PSA) Score from Baseline(Baseline and Week 4)
研究者
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