Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Erythematotelangiectatic Rosacea: A Randomized Clinical Trial
Abstract
Importance: Treatment of facial flushing and erythema for patients with erythematotelangiectatic rosacea (ETR) is challenging. Transcutaneous auricular vagus nerve stimulation (taVNS) therapy may be beneficial for treating ETR; however, it has not been rigorously evaluated in a randomized clinical trial.
Objective: To evaluate the efficacy of taVNS for ETR compared with sham stimulation (SS).
Design, setting, and participants: Enrollment for this single-center, randomized, double-blind, sham-controlled device clinical trial was initiated in February 2024 and ended in August 2024. The follow-up period ended in February 2025, and data were analyzed in March 2025. Patients with ETR that was accompanied by a Clinician's Erythema Assessment (CEA) score of at least 2 were selected from the Department of Dermatology of Southwest Hospital in China.
Interventions: Patients were allocated to the taVNS group (stimulation pulses at a frequency of 30 Hz and a pulse width of 200 μs for 30 minutes per day) or the SS group at a 1:1 ratio. Both groups received 3 weeks of treatment and 24 weeks of follow-up.
Main outcomes and measures: The primary outcome was CEA score after 3 weeks of treatment. The secondary outcomes included improvements in erythema and facial flushing, sleep disorders, migraine, anxiety, fatigue, and depression, as measured via clinical tools.
Results: Seventy-two participants (67 female individuals [93.1%]; median [IQR] age: 29.5 [24.0-36.0] years) with ETR were…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 67 participants or records.
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