Effect of Topical Brimonidine on Alcohol-Induced Flushing in Asian Individuals: A Randomized Clinical Trial

Abstract

Importance: Alcohol flushing syndrome (AFS, also known as Asian glow and Asian flush) affects 20% to 47% of East Asians and causes significant psychosocial distress. There are no approved treatments for this condition.

Objective: To determine whether brimonidine gel, 0.33%, decreases facial erythema in patients with AFS after consumption of alcohol.

Design, setting, and participants: In this randomized clinical trial, 20 healthy volunteers of East Asian descent with a self-reported history of AFS were recruited between April 2018 and March 2019.

Interventions: Participants were randomized to application of brimonidine gel to either the left or right half of their face. Placebo control was applied to the opposite side. After 30 minutes, participants ingested alcohol.

Main outcomes and measures: Outcomes were specified before data collection. The difference in erythema between the treated and placebo side of each participant's face was measured 60 minutes after drug application (primary outcome) and at 90 and 120 minutes after drug application (secondary outcomes). Participants were asked to rate their likelihood of using the medication again and their likelihood of recommending the medication to a friend on a scale of 0 to 10.

Results: The mean (SD) age of the 20 individuals enrolled in the study was 30.5 (8.4) years, and there were 10 women (50%). There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001). This effect persisted at 90 and 120 minutes. Individuals were likely to use the medication again (7.2; 95% CI, 6.0-8.3) and would also recommend it to a friend (7.6; 95% CI, 6.5-8.6).

Conclusions and relevance: This study demonstrates that brimonidine gel is effective in reducing the facial erythema of AFS. Patients with psychosocial distress due to AFS may benefit from treatment with brimonidine.

Trial registration: ClinicalTrials.gov identifier: NCT03497442.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Arron is an investigator for Leo Pharma, SunPharma, Menlo Therapeutics, Castle Biosciences, Genentech, Pfizer, Regeneron, Eli Lilly and Company, and PellePharm and a consultant for Enspectra Health, Regeneron, Sanofi Genzyme, Castle Creek Pharmaceuticals, SunPharma, Biossance, Gerson Lehrman Group, and Rakuten Medical. No other disclosures were reported.

Figures

Figure 1.. Patient Flow Diagram

Figure 2.. Erythema Scores Plotted With Respect to Time After Drug Application

Scores were assessed both by a blinded clinician (A) and by the blinded participant (B). Application of drug and placebo occurred immediately after the baseline evaluation (time 0). Ethanol was administered immediately after the 30-minute evaluation (time 30). Clinical photographs were taken at baseline (C, E) and 60 minutes after drinking alcohol (B, D). Both participants in these photographs had placebo applied to the right side of the face and brimonidine gel applied to the left side of the face. The periorbital area was not treated. NA indicates not applicable.