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Multicenter, randomized, double-blind, placebo-controlled clinical trial for the efficacy and safety of paroxetine in the treatment of intractable rosacea

Multicenter, randomized, double-blind, placebo-controlled clinical trial for the efficacy and safety of paroxetine in the treatment of intractable rosacea

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073083
Enrollment
Unknown
Registered
2023-06-30
Start date
2023-08-16
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Interventions

Conventional dose group:Oral paroxetine, 25mg Qd, Four Months
Low dose group:Oral (paroxetine 12.5mg + placebo 12.5mg), Qd, Four Months.
Control group:Oral placebo, 25mg, Qd, Four Months

Sponsors

Xiangya Hospital Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Definition of intractable rosacea: after 12 weeks of oral administration of conventional drugs such as doxycycline, with or without other treatments (topical drugs /IPL, etc.), patients with treatment resistance (erythema not reduced by 1 grade or erythema greater than or equal to 3 degrees), or patients with frequent recurrence during 12 weeks of treatment. 2. And signed the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Age 65 years; 2. Pregnant and breastfeeding women and with recent pregnancy plans; 3. With nasal hyperplasia hypertrophy rosacea patients; 4. Patients with moderate or severe liver, kidney, lung or blood and other systemic diseases; 5. Suspected gastric acid deficiency, acute or chronic gastrointestinal ulcer or duodenal surgery (cannot absorb drugs); 6. History of mental illness; 7. Paroxetine allergy; 8. Patients with oral amine oxidase inhibitors (such as phenylethylhydrazine, seligilan, etc.); 9. Topical treatment was given within 2 weeks, systemic treatment with common drugs within 4 weeks or isotretinoic acid within 6 months; 10. Combined with other facial skin diseases (such as seborrheic dermatitis, eczema, etc.) or the facial manifestations of other diseases (such as dermatomyositis, systemic lupus erythematosus); 11. Patients who are not expected to follow up; 12. Participants in any clinical trial within one month; 13. Other ineligible conditions were considered by the researchers.

Design outcomes

Primary

MeasureTime frame
Clinical Erythema Assessment Effective Improvement Rate;

Secondary

MeasureTime frame
Rosacea Clinical Symptom Severity Assessment (Patient Self Assessment);Rating of existing skin lesions (physician evaluation);Flushing Assessment tool (patient evaluation) score;Skin Life Quality Index (DLQI) Questionnaire Score;Depression Anxiety Stress Scale (DASS-21) Score;Facial photographs ;VISIA facial imaging changes;

Countries

China

Contacts

Public ContactBen Wang

Dermatology Hospital of Central South University Xiangya Hospital

wangben0804@163.com+86 138 7588 5737

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026