NCT01701843终止2 期
A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Evaluation of mechanically induced changes of lesions
研究概览
简要总结
The purpose of this exploratory study is to investigate the clinical efficacy of study drug (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded, randomised, single centre setting.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent has been obtained
- •Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign
- •Age between 18 and 70 years
- •Either sex
- •Any race or ethnicity
- •Attending hospital outpatient clinic or the private practice of a dermatologist.
排除标准
- •The presence of autoimmune and infectious disease including aggressive systemic mastocytosis
- •Medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- •Medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia
- •Evidence of severe renal dysfunction (creatinine > 1,5 times upper reference value)
- •Evidence of significant hepatic disease (liver enzymes > 2 times upper reference value)
- •Presence of active cancer which requires chemotherapy or radiation therapy
- •Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG
- •Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
- •Intake of oral corticosteroids within 14 days prior to randomisation
- •Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to randomisation
- •Radiation therapy of target areas including UV therapy within 4 weeks prior to randomisation
- •Confounding other dermatological diseases or conditions that can affect the symptoms of the target areas
- •Known or suspected hypersensitivity to component(s) of investigational products.
- •Current participation in any other interventional clinical trial.
- •Subjects who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
- •Previously randomised in this clinical trial
- •In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
- •Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
- •Females of child-bearing potential with positive pregnancy test at visit
- •Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
研究组 & 干预措施
Placebo (left) / Cromoglicate (right)
Other
Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside)
干预措施: Cromoglicate (Drug)
Placebo (left) / Cromoglicate (right)
Other
Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside)
干预措施: Placebo (Drug)
Placebo (right) / Cromoglicate (left)
Other
Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside)
干预措施: Cromoglicate (Drug)
Placebo (right) / Cromoglicate (left)
Other
Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside)
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of mechanically induced changes of lesions
时间窗: Baseline to week 2
次要结局
- Evaluation of mechanically induced wheal and flare response(Baseline to week 2)
研究者
研究点 (1)
Loading locations...
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