ChiCTR2600117795 版本V1.0 版本创建时间2026/01/29 08:22:52 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600117795 

最近更新日期：

Date of Last Refreshed on：

2026-01-29 08:22:47 

注册时间：

Date of Registration：

2026-01-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Qasim S. Al Chalabi 

研究负责人：

Ahmed M. Al Obaidi 

Applicant：

Qasim S. Al Chalabi 

Study leader：

Ahmed M. Al Obaidi 

申请注册联系人电话：

Applicant telephone：

+964 770 161 8688

研究负责人电话：

Study leader's telephone：

+964 770 161 8688

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

Qasimalchalabi@uomosul.edu.iq

研究负责人电子邮件：

Study leader's E-mail：

Qasimalchalabi@uomosul.edu.iq

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

94QJ+XWG, 80, Mosul, Nineveh Governorate

研究负责人通讯地址：

94QJ+XWG, 80, Mosul, Nineveh Governorate

Applicant address：

94QJ+XWG, 80, Mosul, Nineveh Governorate

Study leader's address：

94QJ+XWG, 80, Mosul, Nineveh Governorate

申请注册联系人邮政编码：

Applicant postcode：

41002

研究负责人邮政编码：

Study leader's postcode：

41002

申请人所在单位：

University of Mosul

Applicant's institution：

University of Mosul

研究负责人所在单位：

University of Mosul

Affiliation of the Leader：

University of Mosul

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

UOM\COM\MERC\25-26\JAN19

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Medical Ethics Research Committee (MERC) of University of Mosul

Name of the ethic committee：

Medical Ethics Research Committee (MERC) of University of Mosul

伦理委员会批准日期：

Date of approved by ethic committee：

2026-01-19 00:00:00

伦理委员会联系人：

Professor Dr. Azzam Abdul-kadir Ahmed

Contact Name of the ethic committee：

Professor Dr. Azzam Abdul-kadir Ahmed

伦理委员会联系地址：

94QJ+XWG, 80, Mosul, Nineveh Governorate

Contact Address of the ethic committee：

94QJ+XWG, 80, Mosul, Nineveh Governorate

伦理委员会联系人电话：

Contact phone of the ethic committee：

+964 770 457 9617

伦理委员会联系人邮箱：

Contact email of the ethic committee：

medicine@uomosul.edu.iq

研究实施负责（组长）单位：

University of Mosul

Primary sponsor：

University of Mosul

研究实施负责（组长）单位地址：

94QJ+XWG, 80, Mosul, Nineveh Governorate

Primary sponsor's address：

94QJ+XWG, 80, Mosul, Nineveh Governorate

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Iraq

省(直辖市)：

Nineveh

市(区县)：

Mosul

Country：

Iraq

Province：

Nineveh

City：

Mosul

单位(医院)：

University of Mosul

具体地址：

Al Majmoah Street, Mosul, Iraq

Institution
hospital：

University of Mosul

Address：

Al Majmoah Street, Mosul, Iraq

经费或物资来源：

University of Mosul

Source(s) of funding：

University of Mosul

Target disease：

Rosacea

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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

Objectives of Study：

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

药物成份或治疗方案详述：

Patients were instructed to apply a thin layer of the treatment prescribed on involved facial regions twice daily (morning and night) after mild washing with a nonirritating soap-free cleanser. Patients could use an everyday sunscreen (SPF 50, broad spectrum, non-comedogenic) as needed during the day. Patients were instructed to avoid sun exposure, spicy diet, alcohol intake, emotional stress, and exposure to extreme temperatures. 

Description for medicine or protocol of treatment in detail：

Patients were instructed to apply a thin layer of the treatment prescribed on involved facial regions twice daily (morning and night) after mild washing with a nonirritating soap-free cleanser. Patients could use an everyday sunscreen (SPF 50, broad spectrum, non-comedogenic) as needed during the day. Patients were instructed to avoid sun exposure, spicy diet, alcohol intake, emotional stress, and exposure to extreme temperatures. 

纳入标准：

- 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.

Inclusion criteria

- 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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2026-01-19 00:00:00至 To 2026-08-14 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-29 00:00:00 至 To 2026-06-18 00:00:00  

干预措施：

Interventions：

组别：

Tofacitinib Group

样本量：

30

Group：

Tofacitinib Group

Sample size：

干预措施：

Topical application of Tofacitinib ointment twice daily

干预措施代码：

Intervention：

Topical application of Tofacitinib ointment twice daily

Intervention code：

组别：

Metronidazole Group

样本量：

30

Group：

Metronidazole Group

Sample size：

干预措施：

Topical application of Metronidazole ointment twice daily

干预措施代码：

Intervention：

Topical application of Metronidazole ointment twice daily

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Iraq

省(直辖市)：

 Nineveh 

市(区县)：

 Mosul 

Country：

Iraq 

Province：

Nineveh 

City：

Mosul 

单位(医院)：

Al Salam Teaching Hospital 

单位级别：

N/A 

Institution
hospital：

Al Salam Teaching Hospital

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

Change in Investigator's Global Assessment (IGA) score from baseline to week 16, on a validated 5-point scale (0 = clear, 4 = severe)

指标类型：

主要指标

Outcome：

Change in Investigator's Global Assessment (IGA) score from baseline to week 16, on a validated 5-point scale (0 = clear, 4 = severe)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Baseline to Week 16 change in Erythema Severity Score (ESS) on a 4-point scale (0 = none, 3 = severe)

指标类型：

主要指标

Outcome：

Baseline to Week 16 change in Erythema Severity Score (ESS) on a 4-point scale (0 = none, 3 = severe)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Percentage of patients with >=2-point reduction in IGA score

指标类型：

次要指标

Outcome：

Percentage of patients with >=2-point reduction in IGA score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Change in Patient Satisfaction Score (PSS) on a 10-point Likert scale at week 16

指标类型：

次要指标

Outcome：

Change in Patient Satisfaction Score (PSS) on a 10-point Likert scale at week 16

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Incidence and severity of flushing episodes by patient report (via patient diaries)

指标类型：

次要指标

Outcome：

Incidence and severity of flushing episodes by patient report (via patient diaries)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Change in visibility of telangiectasia (assessed using standardized photographs)

指标类型：

次要指标

Outcome：

Change in visibility of telangiectasia (assessed using standardized photographs)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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)

Randomization Procedure (please state who generates the random number sequence and by what method)：

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)

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

None

Blinding：

None

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

None

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-01-29 08:22:47