jRCT2031240257已完成不适用
A Phase I, repeated application study with SKE-18 1% cream in patients with persistent facial erythema associated with rosacea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Japanese males or female aged 18 years or older at the time of signing the Informed Consent Form
- •Patients diagnosed with rosacea
- •Patients with moderate to severe persistent facial erythema associated with rosacea
- •Patients who received full explanations regarding the objective of the study, details of the study and the study drug and provided voluntary written informed consent
排除标准
- •Patients with severe or unstable or uncontrolled cardiovascular disease, or with a medical history of such disease
- •Patients with uncontrolled hypertension or hypotension
- •Patients with cerebral or coronary insufficiency, Raynaud's syndrome thromboangiitis obliterans, scleroderma, Sjogren's syndrome
- •Patients with closed-angle glaucoma or open-angle glaucoma with a narrow-angle eye
- •Patients with inflammatory lesions (papules and pustules) of >=4 on the face
- •Patients with significant intra- and inter-day fluctuations in erythema associated with rosacea
- •Patients considered ineligible for the study by the investigator
结局指标
主要结局
-
Pharmacokinetic parameters and plasma concentration-time profile of SKE-18
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
1 期
The purpose of this study is to evaluate the steady state pharmacokinetics and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed pregnant women in their second and third trimesters.Human Immunodeficiency Virus (HIV-1) InfectionsMedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862EUCTR2021-001073-23-Outside-EU/EEAGilead Sciences, Inc.
进行中（未招募）
1 期
MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin AloneEUCTR2011-002803-13-SEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.119
进行中（未招募）
1 期
MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin AloneEUCTR2011-002803-13-HUMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.119
进行中（未招募）
1 期
MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin AloneMedDRA version: 18.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864Ovarian cancerEUCTR2011-002803-13-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.119
尚未招募
3 期
Effect of KECTS (Knee Expert Clinic Treatment Strategy) on Knee osteoarthritisCTRI/2024/06/068462TECH CLINIC CONNECT PRIVATE LIMITED