NCT00544687已完成1 期
A Phase I, Single-Center, Randomized, Vehicle and Active-Controlled Study to Assess and Compare the Atrophy-Causing Potential of Topical CRx-191 Formulations in Healthy Volunteers
Zalicus1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
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
- Full skin thinning produced by treatment of CRx-191 in comparison with its components at corresponding dose levels, and vehicle with a marketed corticosteriod. Assess tolerability and safety of CRx-191.
研究概览
简要总结
CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of psoriasis.
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 (Participant, Investigator)
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
- •Subject must voluntarily give written informed consent
- •Subject must be at least 18 years of age
- •Subject must have healthy skin on which reddening can be easily recognized in the area of the test fields
- •The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study
- •Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen; systemic contraceptive (combined oral contraceptive, implant, injection), or safe intrauterine device (IUD)
- •Written informed consent obtained
排除标准
- •Acne, suntan, eczema, hyper- or hypopigmentation, or tattoos in the test fields
- •Dark skinned persons whose skin color prevents ready assessment of skin reactions
- •Cardiac disease including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
- •Narrow angle glaucoma
- •Hyperthyroidism by medical history, TSH < LLN, or receiving thyroid medication
- •Severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values that exceed 1.5x ULN)
- •Inflammatory dermatoses (e.g. atopic dermatitis, psoriasis), bacterial, viral, or fungal skin infections; facial rosacea
- •Active varicella, tuberculosis, syphilis or post-vaccine reactions
- •Autoimmune disease (e.g., lupus erythematosis)
- •Known allergic reactions or hypersensitivity to any of the components of the study preparations
- •Allergy to adhesives on the patches used for occlusion in this study
- •UV therapy in the four weeks before the study
- •History of malignancy (except for treated or excised basal cell carcinoma)
- •Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- •History of drug or alcohol abuse (as defined by the Investigator)
- •Symptoms of a clinically significant illness in the four weeks before the study that may influence the outcome of the study
- •Positive for human immunodeficiency virus (HIV) antibody
- •Systemic treatments in the two weeks preceding and during the study that may interact with any of the study drugs, such as: Glucocorticoids (po, im, iv), MAO inhibitors, Anti-depressants, Anti-seizure medications, Anti-psychotics, Antihistamines
- •Subjects who require medications that inhibit the cytochrome P450 (CYP450) 2D6 pathway such as: Quinidine, Cimetidine, Type 1 antiarrhythmics, Phenothiazines, Selective serotonin reuptake inhibitors such as fluoxetine, paroxetine, and sertraline, reserpine, other anticholinergic drugs, and sympathomimetic drugs
- •Participation in another clinical trial and/or treatment received with any investigational agent within one month before the initial dose of study medication
- •Female subject who is pregnant or lactating
- •Significant UV exposure in the four weeks before the study
- •Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
- •Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment
- •Subject is institutionalized because of legal or regulatory order
研究组 & 干预措施
1
Experimental
CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl)
干预措施: CRx-191 (Drug)
2
Experimental
CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl)
干预措施: CRx-191 (Drug)
3
Active Comparator
0.1% mometasone furoate
干预措施: mometasone furoate (Drug)
4
Active Comparator
0.1% nortriptyline HCl
干预措施: nortriptyline HCl (Drug)
5
Active Comparator
Karison® Creme (clobetasol-17-propinate 0.05%)
干预措施: Karison® Creme (Drug)
6
Placebo Comparator
Vehicle (placebo)
干预措施: Vehicle (Drug)
结局指标
主要结局
Full skin thinning produced by treatment of CRx-191 in comparison with its components at corresponding dose levels, and vehicle with a marketed corticosteriod. Assess tolerability and safety of CRx-191.
时间窗: 28 Days
次要结局
未报告次要终点
研究者
研究点 (1)
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