Rosacea
Conditions
Interventions
Tofacitinib group:Tofacitinib 5mg, orally twice daily
after the 16th week, the dosage should be reduced to Tofacitinib 5mg, orally once daily.
Upadacitinib group:Upadacitinib 15mg, orally once daily
after the 16th week, the dosage should be reduced to Upadacitinib 15mg, orally once every other day.
Carvedilol group:Carvedilol 5mg, orally twice daily
after the 16th week, the dosage should be reduced to Carvedilol 5mg, orally once daily.
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Attending our outpatient department or the Acne and Rosacea Specialty Clinic during the study period; (2) Age: 18-65 years; (3) Gender: (no restriction); (4) Clinically diagnosed with ETR (according to the "2021 Chinese Diagnostic Criteria for Rosacea").
Exclusion criteria
Exclusion criteria: (1) Presence of other active dermatological conditions that may interfere with the study evaluation, aside from ETR; (2) Previous treatment with JAK inhibitors or other systemic immunosuppressive therapies; (3) Presence of severe systemic diseases: such as cardiovascular diseases, hepatic insufficiency, moderate to severe renal insufficiency, history of organ transplantation, history of malignant tumors, elderly patients with a history of severe diabetes, or individuals with a history of psychiatric disorders; (4) Pregnancy, suspected pregnancy, and lactating women; (5) Allergy to upadacitinib, tofacitinib, or carvedilol; (6) Contraindications to upadacitinib, tofacitinib, or carvedilol (wherein: Upadacitinib contraindications: a. Hypersensitivity to the active ingredient or any excipient; b. Active tuberculosis or active severe infections; c. Severe hepatic impairment; d. Pregnancy. Tofacitinib contraindications: None. Carvedilol contraindications: a. Decompensated heart failure requiring intravenous inotropic therapy (NYHA Class IV); b. Patients with asthma; c. Patients with chronic obstructive pulmonary disease (COPD) accompanied by bronchospasm; d. Patients with manifested hepatic dysfunction; e. Patients with second- or third-degree atrioventricular block; f. Patients with severe bradycardia (heart rate <50 beats per minute); g. Patients with cardiogenic shock; h. Patients with sick sinus syndrome (including sinoatrial block); i. Patients with severe hypotension (systolic blood pressure <85 mmHg); j. Patients allergic to carvedilol; k. Cardiogenic shock; l. Severe hypotension (systolic blood pressure <85 mmHg); m. Within 48 hours prior to surgery.); (7) Missing study-related medical history; (8) Unable to comply with treatment or follow-up for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Erythema Assessment Effective Improvement Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator's Global Assessment (IGA) Treatment Success Rate; Global Flushing Severity Scale (GFSS) Score;Rosacea-Specific Quality of Life Scale (RosQoL) Score;Anxiety and Depression Rating Scale (DASS-21) Score; | — |
Countries
China
Contacts
Public ContactZhang Chengfeng/Zhang Jiawen
Huashan Hospital, Fudan University
Outcome results
None listed