Gabapentin Alone and in Combination With Carvedilol for the Treatment of Rosacea-Associated Flushing and Erythema:a Randomized Controlled Clinical Trial

Phase 1

Completed

• Conditions: Rosacea; Rosacea Subtype 1 (Erythematotelangiectatic)
• Interventions: Drug: minocycline combined with hydroxychloroquine; Drug: gabapentin 300mg bid; Drug: gabapentin 300mg tid

• Registration Number: NCT06776445
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Brief Summary

The goal of this clinical trial is to learn if Gabapentin works to treat flushing/erythema associated with rosacea. It will also learn about the safety of drug Gabapentin. The main questions it aims to answer are:

* Does drug Gabapentin reduce flushing and erythema associated with rosacea?

* What medical problems do participants have when taking drug Gabapentin? Researchers will compare Gabapentin to a positive control (minocycline plus hydroxychloroquine, a first-line treatment for rosacea) to see if drug Gabapentin works to reduce flushing and erythema associated with rosacea

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-05
• Primary Completion: 2024-12-30
• Status Verified: 2025-01
• Study Completion: 2025-01-06
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Initial treatment in our hospital; ② Diagnosed by two experienced dermatologists and in accordance with the updated diagnostic criteria of the National Rosacea Society (NRS) Expert Committee [38], unconscious disorder and no communication disorder; ③ did not receive any other form of treatment within 4 weeks; ④ Patients who were followed up for 8 weeks or more and had complete clinical data; ⑤ Informed consent was signed before treatment, and the clinical data were agreed to be used for scientific research

Exclusion Criteria

① received other treatment within 4 weeks of this treatment; ② facial flushing caused by other diseases and local irritation; ③ Patients with contraindication to minocycline, hydroxychloroquine, gabapentin and carvedilol; ④ Unable to complete follow-up and serum specimen collection; ○5 patients were intolerant to minocycline, hydroxychloroquine and carvedilol; ○6 Lactation, pregnancy, liver and kidney dysfunction, psychiatric diseases, cardiovascular and cerebrovascular diseases, systemic lupus erythematosus and other systemic diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
minocycline combined with hydroxychloroquine	minocycline combined with hydroxychloroquine	-
gabapentin 300mg bid	gabapentin 300mg bid	-
gabapentin 300mg tid	gabapentin 300mg tid	-

Primary Outcome Measures

Name	Time	Method
the score of CEA ( Clinician Erythema Assessment )	4 weeks, 8 weeks, 12 weeks after treatment	The reduction of the CEA score was compared before treatment, 4 weeks and 8 weeks, 12 weeks after treatment. The CEA score was assessed by a scale, 0 = clear, 1= almost clear, 2 =Mild, 3= Moderate,4= Severe.

Trial Locations

Locations (1)

First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China