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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031479
Enrollment
Unknown
Registered
2020-04-02
Start date
2020-04-13
Completion date
Unknown
Last updated
2020-04-06

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

Conditions

Rosacea

Interventions

experimental group:Paroxetine
control group:placebo

Sponsors

Xiangya Hospital Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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. And signed the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: Subjects who meet one of the following conditions will not be included in the study: (1) Age 65 years old. (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
Assessment of clinical severity of rosacea;Assessment of clinical severity of rosacea;

Secondary

MeasureTime frame
Quality of life scale for patients with rosacea;Anxiety and depression rating scale;A clinical photograph of the face of a patient with rosacea;A VISIA photograph of the face of a patient with rosacea;

Countries

China

Contacts

Public ContactHongfu Xie

Department of Dermatology, Xiangya Hospital, Central South University

xiehongfu@csu.edu.cn+86 13908455353

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 19, 2026