Skip to main content
OpenTrials
Completed

NCT Number: NCT06776445

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rosacea Rosacea Subtype 1 (Erythematotelangiectatic) Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

First Affiliated Hospital of Chongqing Medical University

Chongqing, 404100, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

minocycline combined with hydroxychloroquine

Drug

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

gabapentin 300mg bid

Drug

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

gabapentin 300mg tid

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Acronym: Gabapenti

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.