NCT00666354Unknown2 期
Phase IIB Dose Response and Safety Study of Topical Formulations of Methotrexate (MQX-5902, MQX-5904 and MQX-5906) in the Treatment of Fingernail Psoriasis
MediQuest Therapeutics7 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 83
- 试验地点
- 7
- 主要终点
- Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators.
研究概览
简要总结
The purpose of this clinical study is to compare the efficacy and safety of three concentrations of topical methotrexate for the treatment of fingernail psoriasis.
详细描述
The purpose of this clinical study is to compare, in a controlled fashion, the response to three concentrations of methotrexate in novel topical formulations in the treatment of subjects with psoriasis of the fingernails. Such a determination will be used as the basis for evidence of efficacy and safety of these formulations as a therapeutic treatment for fingernail 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed moderate fingernail psoriasis of at least two fingernails.
- •Stable and unchanged psoriasis therapies for 2 months and must not have received methotrexate for 3 months prior to screening.
- •Female patients who are not 5 years post menopausal or surgically sterile must use appropriate birth control for specified time periods and have negative pregnancy tests.
排除标准
- •Target or control fingernails that are thicker than 2mm, abnormal or infected (bacterial or fungal).
- •Patients with immunosuppression, HIV, or neuropathies of the hand.
- •Use of any methotrexate preparation, any topical anti-psoriatic medications or ultraviolet treatment within 2 months of study visit
- •Use of more that one 2-week course of oral corticosteroid therapy or one injection during 3 months prior to the screening visit.
- •Use of manicures or cosmetic nail products during and within 7 days of the start of treatment.
- •Use of any drug known to have potential for toxicity to a major organ during and within 90 days prior to the start of treatment.
- •Patients who are nursing, pregnant or plan to become pregnant or father a child within the study time frame including within three months of the last dose of study medication.
研究组 & 干预措施
1
Active Comparator
干预措施: Methotrexate (Drug)
2
Active Comparator
干预措施: Methotrexate (Drug)
3
Active Comparator
干预措施: Methotrexate (Drug)
结局指标
主要结局
Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators.
时间窗: Monthly
次要结局
- Improvement in appearance of the control fingernail, improvement of the target fingernail using mNAPSI (a modification of the Nail Psoriasis Severity Index), and comparison of improvement of mNAPSI of the target and control fingernails.(Monthly)
- Information on the relative changes in nail psoriasis severity of the other affected fingernails will be collected.(Monthly)
- Comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs will be performed.(Monthly)
- Assess safety, i.e., the frequency and severity of adverse events associated with MQX-5902, MQX-5904 and MQX-5906 in the treatment of patients with fingernail psoriasis.(Monthly)
研究者
研究点 (7)
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