NCT01096472已完成2 期
Phase IIa, Two-center, Randomized, Double Blind Study With Parallel Groups to Evaluate the Anti-mycotic and Anti-inflammatory Efficacy of Topical Combinational Product LAS 41003 Versus Corresponding Mono-substances in Patients With Inflammatory Tinea Pedis
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
- 120
- 试验地点
- 2
- 主要终点
- Clinical assessment scores and mycological status of fungi (KOH test and mycological culture)
研究概览
简要总结
The aim of this study is to determine the efficacy and safety of a topical application of the combinational cream LAS41003 compared to application of its mono-substances after once daily treatment in patients with inflammatory tinea pedis.
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 tinea pedis caused by dermatophytes on one or both feet, characterized by physician's global assessment score of 2 ("notable signs and symptoms exist") or 3 ("prominent signs and symptoms exist") at baseline;
- •the physical examination must be without other disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- •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;
- •patients must be willing and able to comply with the requirements of the trial protocol;
- •written informed consent obtained.
排除标准
- •patients with hyperkeratotic chronic plantar tinea pedis (moccasin type);
- •receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit;
- •oral antifungal therapies within three months before study entry (8 months for oral terbinafine), systemic antibiotic or corticosteroid treatment, topical corticosteroids within 30 days before study entry;
- •patients with diabetes;
- •patients with compromised circulation;
- •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 the treatment phase and during the study;
- •participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this 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 treatment phase of the study (e.g. glucocorticosteroids);
研究组 & 干预措施
LAS41003
Experimental
Once daily
干预措施: LAS41003 (Drug)
LAS189962
Active Comparator
Once daily
干预措施: LAS189962 (Drug)
LAS189961
Active Comparator
Once daily
干预措施: LAS189961 (Drug)
结局指标
主要结局
Clinical assessment scores and mycological status of fungi (KOH test and mycological culture)
时间窗: 2 weeks
次要结局
- Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration)(2 weeks)
- Local skin reactions, AEs(2 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeNCT03662542Janssen Research & Development, LLC214
已完成
2 期
Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)Acute MalariaNCT05689047Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany38
撤回
2 期
Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's SyndromeTourette's SyndromeNCT01475383Pfizer
已完成
2 期
A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital IchthyosisCongenital IchthyosisNCT04154293LEO Pharma34
尚未招募
2 期
Preoperative Tislelizumab -Cetuximab - Chemotherapy Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell CarcinomaOral Squamous Cell Carcinoma (OSCC)Oropharyngeal Squamous Cell Carcinoma (SCC)Resectable Oral and Oropharyngeal Squamous Cell CarcinomaRecurrent Oral and Oropharyngeal Squamous Cell CarcinomaNCT06728618Shanghai Zhongshan Hospital28