NCT01119339已完成2 期
An Investigator-blind, Controlled Study to Assess the Efficacy of Six Distinct Combinations of LAS 41004 in Different Concentrations Compared to Placebo 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
- 20
- 试验地点
- 1
- 主要终点
- Decrease in skin thickness
研究概览
简要总结
The aim of the study is to intra-individually 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
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 6 month
- •Psoriasis plaques that are suitable to be defined as target area lesions by the following criteria:
- •Psoriasis plaques must be located at 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 psoriasis plaques with at least "2" in each score (Range 0-4) for the three distinct symptoms 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 psoriasis plaques
- •Enough psoriatic surface area to define 8 clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² plaque size
- •Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must adhere to concomitant therapy prohibitions of the test areas and must agree to avoid intense UV exposure of the test areas during the study
- •Written informed consent to participate in the study, prior to any study related procedures, indicating an understanding of the purpose of the study
- •A patient of childbearing potential agrees to use one of the following contraceptive methods for the duration of the study:
- •Strict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed)
- •Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance
- •Intrauterine device (IUD) inserted for at least 1 month prior to study entrance
排除标准
- •Too few body surface area covered with psoriasis plaques that meet the specified inclusion criteria to be defined as 8 clearly distinguishable test areas
- •Any condition that may interfere with the study assessments or sonographic measurements of the skin and/or may have an influence on skin immune response (incl. open wounds)
- •Known adverse reactions of any severity or hypersensitivity to any ingredient of the test products
- •No willingness to avoid induction of heavy sweating, e.g. due to sauna visits, excessive sports activities during the study course
- •No willingness to avoid swimming, bathing or wetting of the designated test areas between visits
- •Pregnant or breast-feeding women
- •A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial (including but not limited to: serious infectious diseases, major surgery within the last 4 weeks, coronary artery disease, renal impairment, hepatic impairment, uncontrolled metabolic diseases, disorders of the calcium metabolism, autoimmune diseases)
- •History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases
- •Current diagnosis of guttate, erythrodermic or pustular psoriasis
- •Patients who did not respect the following wash-out periods prior or during the study
研究组 & 干预措施
LAS 41004 dosage 1
Experimental
干预措施: LAS 41004 (Drug)
LAS 41004 dosage 2
Experimental
干预措施: LAS 41004 (Drug)
LAS 41004 dosage 3
Experimental
干预措施: LAS 41004 (Drug)
LAS 41004 dosage 4
Experimental
干预措施: LAS 41004 (Drug)
LAS 41004 dosage 5
Experimental
干预措施: LAS 41004 (Drug)
LAS 41004 dosage 6
Experimental
干预措施: LAS 41004 dosage 6 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Reference
Active Comparator
干预措施: Reference (Drug)
结局指标
主要结局
Decrease in skin thickness
时间窗: 15 days
measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)
次要结局
- Number of skin reactions per patient as a measure of safety and tolerability(15 days)
- change in clinical score(15 days)
- change in erythema score(15 days)
- change in induration score(15 days)
- Number of Adverse Events per patients as a measure of safety and tolerability(15 days)
- change in scaling score(15 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Clinical Trial to Investigate Efficacy of LAS41004 in PsoriasisPsoriasisNCT01283698Almirall, S.A.20
已完成
2 期
Exploratory Study to Investigate Efficacy of LAS41004 in a Psoriasis Plaque TestPsoriasisNCT01360944Almirall, S.A.22
已完成
2 期
Efficacy and Tolerability of LAS41004 Formulations in a Non-occlusive Psoriasis Plaque TestPsoriasisNCT01462643Almirall, S.A.22
撤回
2 期
Study of LJP 394 (Abetimus Sodium) in Lupus PatientsSystemic Lupus ErythematosusNCT00390091La Jolla Pharmaceutical Company
已完成
1 期
A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy ParticipantsAutoimmune DisorderHealthy VolunteersNCT06342700Sanofi28