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A multicenter, randomized, double-blind, placebo-controlled clinical trial of the clinical efficacy and safety of gabapentin in the treatment of refractory rosacea

A multicenter, randomized, double-blind, placebo-controlled clinical trial of the clinical efficacy and safety of gabapentin in the treatment of refractory rosacea

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058642
Enrollment
Unknown
Registered
2022-04-13
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Rosacea

Interventions

placebo group:Oral placebo 0.3g + original treatment plan
high dose group:Oral gabapentin 0.3g tid
low dose group:Oral gabapentin 0.2g tid + placebo 0.1g

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Definition of refractory rosacea: After 12 weeks (or more) of oral conventional drugs such as doxycycline, with or without other treatments (such as topical drugs/IPL, etc.), treatment resistance (the erythema has not decreased by 1 Patients with grade or erythema greater than or equal to 3 or flushing and other symptoms affecting quality of life (DLQI moderate and above), or patients with frequent recurrence during the 12-week treatment period; 2. Voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Age65; 2. Pregnant and lactating women and those who have a recent pregnancy plan; 3. Patients with systemic diseases such as diabetes, moderate and severe liver, kidney, lung or blood; 4. Patients with depression or mental disorder; 5. Chronic pancreatitis; 6. Facial manifestations of rosacea patients with hypertrophic nose or other facial skin diseases (such as seborrheic dermatitis, eczema, etc.) or other diseases (such as dermatomyositis, systemic lupus erythematosus); 7. Engaged in driving or high-altitude operation or complex mechanical operation; 8. Patients who are not expected to insist on follow-up; 9. Those who have participated in any clinical trial within one month; 10. Allergies to gabapentin or any other component of the drug; 11. Other conditions that the researcher thinks cannot be included in the group.

Design outcomes

Primary

MeasureTime frame
Rosacea Clinical Symptom Severity Assessment (Patient Assessment);Rosacea Clinical Symptom Severity Assessment (Physician Assessment);

Secondary

MeasureTime frame
Quality of life scale for patients with rosacea (self-assessment by patients);Anxiety and Depression Rating Scale (patient self-assessment);Facial clinical photos of rosacea patients;Anxiety and Depression Rating Scale (patient self-assessment);Facial VISIA photos of rosacea patients;Safety indicators (physical examination, vital signs, routine blood and urine, liver and kidney function, adverse events);

Countries

China

Contacts

Public ContactLi Ji

Department of Dermatology, Xiangya Hospital, Central South University

liji_xy@csu.edu.cn+86 15674924749

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026