NCT01360944已完成2 期
An Investigator-blind, Controlled Exploratory Study to Assess the Efficacy and Safety of Different Concentrations of Active Ingredients in the Project LAS 41004 Compared to a Bland Ointment and to Active Control in a Psoriasis- Plaque- Test
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Decrease in thickness of infiltration
研究概览
简要总结
The aim of the exploratory study is to compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT).
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
- Triple (Participant, 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
- •Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 12 months
- •Psoriatic plaques that are suitable to be defined as target area lesions by the following criteria:
- •oPsoriatic plaques must be located on the trunk and/or extremities. Plaques that are located on the head (incl. scalp), palms, sole of the feet, intertriginous or genitoanal areas are not suitable as target areas
- •Comparable psoriatic plaques with at least "2" in each score (range 0-4) for the three distinct signs: scaling, erythema and induration
- •No more than 3 points difference in total score (= sum of scores for scaling, erythema and induration; Range 0-12) of the chosen comparable psoriatic plaques
- •Enough surface area to the psoriatic plaque to define eight clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² size - Effective contraceptive methods for the duration of the study and for the 4 weeks after study drug discontinuation, for a patient of childbearing potential.
排除标准
- •Too small a body surface area covered with psoriasis plaques that meet the specified inclusion criteria
- •Any condition that may interfere with the study assessments or ultrasound measurements of the skin and/or may have an influence on the skin immune response (incl. open wounds)
- •Current diagnosis of guttate, erythrodermic or pustular psoriasis
- •Patients who have received any topical anti-psoriatic drug in the test area within the last 2 weeks before treatment with the IMP.
- •Patients who have received topical products in the test area containing DEET (N,N-diethyl-m-polyamide), a common component of insect repellent products within 1 week before treatment with the IMP.
- •Patients who have received systemic biologics within the last 6 months before treatment with the IMP or any systemic antipsoriatic treatment (corticosteroids, ciclosporin, methotrexate, fumaric acid esters, acitretin etc)within the last 3 months before treatment with the IMP.
- •Significant skin diseases other than plaque-type psoriasis (psoriasis vulgaris), including but not limited to: skin disease due to tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, skin atrophy, striae distensae, increased fragility of skin blood vessels, ichthyosis, ulcers, wounds and reaction after vaccination
- •Significant skin infections (including but not limited to: herpes, varicella, mycotic skin infections, bacterial skin infections or parasitic skin infections)
- •Excessive sunlight exposure within 28 days prior to study entry and during the conduct of the study
- •Usage of any topical formulation (incl. cosmetics, emollients, etc) on the designated target areas during the course of the study
- •Vitamin A intake > 15,000 IU/day
研究组 & 干预措施
LAS 41004, variant 1, once daily
Experimental
variant 1, once daily
干预措施: LAS41004 (Drug)
LAS41004, variant 2, once daily
Experimental
variant 2, once daily
干预措施: LAS41004 (Drug)
LAS41004, variant 3, once daily
Experimental
variant 3, once daily
干预措施: LAS41004 (Drug)
LAS41004, variant 4, once daily
Experimental
variant 4, once daily
干预措施: LAS41004 (Drug)
LAS41004, variant 5, once daily
Experimental
variant 5, once daily
干预措施: LAS41004 (Drug)
LAS41004, variant 6, once daily
Experimental
variant 6, once daily
干预措施: LAS41004 (Drug)
reference
Placebo Comparator
once daily, 100microgram
干预措施: reference (Drug)
reference, once daily
Active Comparator
once daily
干预措施: reference (Drug)
结局指标
主要结局
Decrease in thickness of infiltration
时间窗: Day 1 (baseline) vs day 15 day (final)
measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)
次要结局
- Change in Induration score(day 1 (baseline) vs day 15 (final))
- Change in clinical score(day 1 (baseline) vs day 15 (final))
- Change in erythema score(day1 (baseline) vs day 15 (final))
- Change in Scaling score(day 1 (baseline) vs day 15 (final))
研究者
研究点 (1)
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