Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Erythematotelangiectatic Rosacea: A Randomized Clinical Trial.

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. To evaluate the efficacy of taVNS for ETR compared with sham stimulation (SS). 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. 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. 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. 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%]). 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. Chinese Clinical Trial Register Identifier: ChiCTR2400080637.