Efficacy and Safety of Different Dose Regimens of Gabapentin for Treating Erythema/Flushing in Rosacea: A Randomized Controlled Trial (Gabapenti)

December 30, 2025 updated by: Bin Wei, First Affiliated Hospital of Chongqing Medical University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China, 404100
        • First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: minocycline combined with hydroxychloroquine
Drug: minocycline combined with hydroxychloroquine
Patients with rosacea were collected and randomly divided into three groups for treatment, one group was treated with minocycline combined with hydroxychloroquine, one group was treated with gabapentin 300mg Bid, and the other group was treated with gabapentin 300mg tid. Before treatment, 4 weeks after treatment, and 8 weeks after treatment, the patient's condition score was statistically analyzed, and the efficacy and difference of each group were observed
Active Comparator: gabapentin 300mg bid
Drug: gabapentin 300mg bid
Patients with rosacea were collected and randomly divided into three groups for treatment, one group was treated with minocycline combined with hydroxychloroquine, one group was treated with gabapentin 300mg Bid, and the other group was treated with gabapentin 300mg tid. Before treatment, 4 weeks after treatment, and 8 weeks after treatment, the patient's condition score was statistically analyzed, and the efficacy and difference of each group were observed
Active Comparator: gabapentin 300mg tid
Drug: gabapentin 300mg tid
Patients with rosacea were collected and randomly divided into three groups for treatment, one group was treated with minocycline combined with hydroxychloroquine, one group was treated with gabapentin 300mg Bid, and the other group was treated with gabapentin 300mg tid. Before treatment, 4 weeks after treatment, and 8 weeks after treatment, the patient's condition score was statistically analyzed, and the efficacy and difference of each group were observed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the score of CEA ( Clinician Erythema Assessment )
Time Frame: 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.
4 weeks, 8 weeks, 12 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

January 15, 2025

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024MSXM069 (Other Grant/Funding Number: Joint project of Chongqing Health Commission and Science and Technology Bureau)
  • CSTB2023NSCQ-MSX0078 (Other Grant/Funding Number: Natural Science Foundation of Chongqing, China General Project)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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