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【ChiCTR2600117795】Effectiveness and Safety of Topical Tofacitinib 2% Ointment versus Metronidazole 0.75% Cream in Erythematotelangiectatic Rosacea: A Randomized Controlled Trial.

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基本信息

登记号

ChiCTR2600117795

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2026-01-29

临床申请受理号

靶点

适应症

Rosacea

试验通俗题目

Effectiveness and Safety of Topical Tofacitinib 2% Ointment versus Metronidazole 0.75% Cream in Erythematotelangiectatic Rosacea: A Randomized Controlled Trial.

试验专业题目

Effectiveness and Safety of Topical Tofacitinib 2% Ointment versus Metronidazole 0.75% Cream in Erythematotelangiectatic Rosacea: A Randomized Controlled Trial.

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

41002

联系人通讯地址

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临床试验信息

试验目的

To compare the effectiveness and safety of topical tofacitinib 2% ointment with metronidazole 0.75% cream in patients with moderate-to-severe ETR.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Randomization was done by a computer-generated permuted block randomization method (block size = 6). Group allocation was concealed using sequentially numbered opaque sealed envelopes made by a researcher not involved in clinical assessment. Patients were randomly assigned in a 1:1 ratio to: - Group A: Tofacitinib 2% ointment (n=30) (Tofanol©,Pharma Tower, India) - Group B: Metronidazole 0.75% cream (n=30) (Metroza©,Philadelphia Pharmaceuticals, Jordan)

盲法

None

试验项目经费来源

University of Mosul

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-01-19

试验终止时间

2026-08-14

是否属于一致性

入选标准

- Age between 18 and 65 years. - Clinical diagnosis of ETR of at least 6 months duration. - Investigator's Global Assessment (IGA) score >=3 (moderate to severe) (22). - Fitzpatrick skin types I to IV. - Willingness to comply with all study-related procedures.；

排除标准

Other rosacea subtypes (papulopustular, phymatous, ocular). - Recent (within 4 weeks) systemic corticosteroids, immunosuppressive agents, oral antibiotics, or retinoid use. - Topical rosacea treatment or cosmetic treatments in the past 2 weeks. - Active facial dermatoses, eg, seborrheic dermatitis, lupus erythematosus, acne vulgaris. - History of known allergy to any component of the study medication. - Pregnancy, lactation, or intention to conceive. - Severe systemic disease or immunodeficiency.；

研究者信息

研究负责人姓名

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试验机构

University of Mosul

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

41002

联系人通讯地址