Rosacea
Conditions
Interventions
Tofacitinib Group:Topical application of Tofacitinib ointment twice daily
Metronidazole Group :Topical application of Metronidazole ointment twice daily
Sponsors
University of Mosul
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Investigator's Global Assessment (IGA) score from baseline to week 16, on a validated 5-point scale (0 = clear, 4 = severe);Baseline to Week 16 change in Erythema Severity Score (ESS) on a 4-point scale (0 = none, 3 = severe); | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with >=2-point reduction in IGA score;Change in Patient Satisfaction Score (PSS) on a 10-point Likert scale at week 16;Incidence and severity of flushing episodes by patient report (via patient diaries);Change in visibility of telangiectasia (assessed using standardized photographs); | — |
Countries
Iraq
Contacts
Public ContactAhmed M. Al Obaidi
University of Mosul
Outcome results
None listed