NCT00721331已完成1 期
A Phase I, Single-Center, Randomized, Vehicle-Controlled Study to Assess the Safety and Tolerability of Topical CRx-197 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: 2008年7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
- Safety and tolerability of CRx-197 as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus.
研究概览
简要总结
This will be a phase I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
- •Subject must be 18 to 60 years of age
- •Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test fields
- •Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
- •Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner.
排除标准
- •Suntan, hyper- or hypo-pigmentation, or tattoos in the area where they will place 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 less than LLN, or subject receiving any thyroid medication
- •Severe liver disease - ALT laboratory value that exceeds 1.5x ULN
- •Inflammatory dermatoses (e.g., atopic dermatoses/eczema, psoriasis)
- •Any skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, 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 treatments
- •Allergy to adhesives on the patches used for occlusion in the study
- •UV therapy or significant UV exposure in the four weeks before treatment application
- •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 treatment application that may influence the outcome of the study
- •Positive for HIV antibody
- •Systemic treatments in the four weeks prior to treatment application that may interact with any of the study drugs, such as: Glucocorticoids, MAO inhibitors, anti-depressants, anti-seizure medications, anti-psychotics and anti-histamines
- •Subjects who require medications that inhibit the CYP450 2D6 pathway such as:Quinidine, Cimetidine, Type 1 anti-arrhythmic, Phenothiazines, Selective serotonin reuptake inhibitors, Reserpine, other anticholinergic drugs, and sympathomimetic drugs
- •Treatment with any investigational agent within one month before treatment application for this trial
- •Female subject who is pregnant , lactating, or with a positive pregnancy test
- •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, make the subject unsuitable for enrollment
- •Subject is institutionalized because of legal or regulatory order
研究组 & 干预措施
CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine)
Experimental
干预措施: nortriptyline HCl + loratadine (Drug)
CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine)
Experimental
干预措施: nortriptyline HCl + loratadine (Drug)
0.1% nortriptyline HCl
Experimental
干预措施: nortriptyline HCl (Drug)
0.1% mometasone furoate
Active Comparator
干预措施: mometasone furoate (Drug)
Active ingredient free vehicle cream of CRx-197
Placebo Comparator
干预措施: Active ingredient free vehicle cream of CRx-197 (Drug)
结局指标
主要结局
Safety and tolerability of CRx-197 as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus.
时间窗: 2 months
次要结局
- Difference in change from baseline in psoriatic infiltrate measured by ultrasound between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s)(Days 8, 15, 22, 29 and 43)
- Difference in change from baseline in erythema measured by chronometry between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin(Days 8, 15, 22, 29 and 43)
- Modified PASI between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s)(Baseline, and Days 8, 15, 22, 29 and 43)
研究者
研究点 (1)
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