NCT01102387已完成2 期
Phase IIa, Two-centre, Randomized, Double Blind Study to Evaluate the Anti-mycotic and Anti-inflammatory Efficacy of Topical Combinational Product LAS41003 Versus Corresponding Mono-substances in Patients With Candida Infections in Intertriginous Areas at the Trunk
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
- 137
- 试验地点
- 6
- 主要终点
- Clinical efficacy and mycological culture
研究概览
简要总结
The aim of this study is to determine the efficacy and safety of once daily topical application of the combinational cream LAS41003 compared to the corresponding mono-substances in the treatment of candida infections in intertriginous areas at the trunk.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of candida infections in one or more intertriginous areas (trunk), confirmed by positive mycological sample at baseline;
- •female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
- •written informed consent
排除标准
- •receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit;
- •patients who have been treated with oral anti-fungal agents within the 12 weeks prior to study entry or treated with topical anti-fungal agents on the intertrigines within the previous 2 weeks;
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •treatment with any other investigational drug in the four weeks preceding the study;
- •known allergic reactions to components of the study preparations, hypersensitivity against cetylstearyl alcohol;
- •treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study (e.g. glucocorticosteroids);
- •in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable non-compliance or inability to
研究组 & 干预措施
LAS41003
Experimental
干预措施: LAS41003 (Drug)
LAS189962
Active Comparator
干预措施: LAS189962 (Drug)
LAS189961
Active Comparator
干预措施: LAS189961 (Drug)
结局指标
主要结局
Clinical efficacy and mycological culture
时间窗: Day 14
Clinical assesment scores and mycological status of candida (mycological culture)
次要结局
- Physical examination, AEs(14 Days)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
A Twelve Week Safety and Efficacy Study in RosaceaPapulopustular RosaceaNCT01784133Maruho Co., Ltd.240
已完成
2 期
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) PathwayGenetic ObesityNCT04963231Rhythm Pharmaceuticals, Inc.164
已完成
3 期
Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big ToenailOnychomycosisNCT00443820Novartis Pharmaceuticals526
已完成
3 期
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big ToenailOnychomycosisNCT00443898Novartis Pharmaceuticals518
已完成
2 期
Efficacy and Safety of LAS41003 in the Treatment of Inflammatory Tinea PedisTinea PedisNCT01096472Almirall, S.A.120