NCT01670513Unknown1 期
A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118
Dow Pharmaceutical Sciences2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The incidence of HPA axis suppression after treatment with investigational drug product and the comparators
研究概览
简要总结
Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.
详细描述
Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race, 18 to 65 (inclusive) years of age.
- •Freely given verbal and written informed consent obtained from the subject.
- •Clinical diagnosis of psoriasis at the Screening and Baseline visits with
- •At least 10% - 20% of total treatable BSA involvement, and
- •an Investigator's Global Evaluation score of 3 or 4 ( moderate or severe) on a scale of 0 to 5
- •Good general health as determined by the Investigator based on the subject's medical history and physical examination, with Screening hematology, serum chemistry, and urinalysis laboratory values within normal range limits.
排除标准
- •Presence of psoriasis that was previously treated with prescription medication prior to the Screening visit and is non-responsive to corticosteroid treatment, as determined by the Investigator.
- •Presence of any concurrent skin condition that could interfere with the evaluation of the study drug, as determined by the Investigator.
- •History of adrenal disease
- •Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
研究组 & 干预措施
IDP-118 Low Strength
Experimental
IDP-118 Low Strength
干预措施: IDP-118 Low Strength (Drug)
IDP-118 High Strength
Experimental
IDP-118 High Strength
干预措施: IDP-118 High Strength (Drug)
结局指标
主要结局
The incidence of HPA axis suppression after treatment with investigational drug product and the comparators
时间窗: 8 weeks
To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators
次要结局
- To evaluate the safety and cutaneous tolerability of the two formulations and the comparators(8 weeks)
研究者
研究点 (2)
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