Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Erythematotelangiectatic Rosacea

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 randomized into either the taVNS (36 [50.0%]) or SS groups (36 [50.0%]). At 3 weeks, the mean (SD) CEA score was lower in the taVNS group than the SS group (1.56 [0.84] vs 2.47 [0.81]; mean difference, −0.92; 95% CI, −1.3 to −0.53; P < .001). Moreover, taVNS also reduced the severity of anxiety (mean difference, −5.42; 95% CI, −8.11 to −2.73; P < .001) and depression (mean difference, −6.22; 95% CI, −9.69 to −2.75; P < .001). This relief persisted until the follow-up period. The effects on sleep disorders, migraine, and fatigue were consistent with the previously described indicators. Adverse events were not common for taVNS (2 of 36 [5.6%]) and SS (3 of 36 [8.3%]). Conclusions and Relevance This randomized clinical trial demonstrated that treating ETR with taVNS concurrently ameliorated cutaneous symptoms and systemic comorbidities, and the results suggest that taVNS is a novel therapeutic option for ETR management. Trial Registration Chinese Clinical Trial Register Identifier: ChiCTR2400080637