JAMA Dermatology

<jats:sec><jats:title>Importance</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To evaluate the efficacy of taVNS for ETR compared with sham stimulation (SS).</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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; <jats:italic>P</jats:italic> &amp;amp;lt; .001). Moreover, taVNS also reduced the severity of anxiety (mean difference, −5.42; 95% CI, −8.11 to −2.73; <jats:italic>P</jats:italic> &amp;amp;lt; .001) and depression (mean difference, −6.22; 95% CI, −9.69 to −2.75; <jats:italic>P</jats:italic> &amp;amp;lt; .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%]).</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>Chinese Clinical Trial Register Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.chictr.org.cn/hvshowproject.html?id=245983&amp;amp;amp;v=1.0">ChiCTR2400080637</jats:ext-link></jats:p></jats:sec>

Epidemiology of acne and rosacea: a worldwide global study.

J Am Acad Dermatol

Patients with rosacea have increased risk of depression and anxiety disorders: a Danish nationwide cohort study.

Dermatology

The relationship between migraine and rosacea: systematic review and meta-analysis.

Cephalalgia

Relationship between rosacea and sleep.

J Dermatol

Exploring the lived experience of women with rosacea: visible difference and psychological impact.

Br J Dermatol

Managing a burning face: clinical manifestations and therapeutic approaches for neurogenic rosacea.

Int J Mol Sci

Therapeutic strategies focusing on immune dysregulation and neuroinflammation in rosacea.

Front Immunol

Paroxetine is an effective treatment for refractory erythema of rosacea: primary results from the prospective rosacea refractory erythema randomized clinical trial.

Carvedilol ameliorates persistent erythema of erythematotelangiectatic rosacea by regulating the status of anxiety/depression.

Comparison of 3 treatment strategies for medication overuse headache: a randomized clinical trial.

JAMA Neurol

Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study.

J Neural Transm (Vienna)

The effects of transcutaneous vagus nerve stimulation on conditioned fear extinction in humans.

Neurobiol Learn Mem

Vagus nerve and vagus nerve stimulation, a comprehensive review: part I.

Headache

Transcutaneous auricular vagus nerve stimulation treatment for cutaneous dirt-adherent disease complicated with rosacea.

Indian J Dermatol Venereol Leprol

Standard classification and pathophysiology of rosacea: the 2017 update by the National Rosacea Society Expert Committee.

Reliability of clinician erythema assessment grading scale.

Erythema of rosacea: validation of patient’s self-assessment grading scale.

J Drugs Dermatol

Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial.

Int J Clin Pract

The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response.

Sleep (Basel)

Gabapentin is an efficacy treatment for facial flushing and erythema of erythematotelangiectatic rosacea: a randomized clinical noninferiority trial.

The work and social adjustment scale: reliability, sensitivity and value.

Int J Psychiatry Clin Pract

Screening for depression in primary care with Patient Health Questionnaire-9 (PHQ-9): a systematic review.

J Affect Disord

Fatigue in the general population: a translation and test of the psychometric properties of the Norwegian version of the fatigue severity scale.

Scand J Public Health

A win ratio approach to comparing continuous non-normal outcomes in clinical trials.

Pharm Stat

Is vagal-nerve stimulation safe during pregnancy? a mini review.

Epilepsy Res

Neural reflexes in inflammation and immunity.

J Exp Med

LncRNA NEAT1 targets miR-125/ADAM9 mediated NF-?B pathway in inflammatory response of rosacea.

Skin Res Technol

Increased frequency of circulating classical monocytes in patients with rosacea.

Clin Cosmet Investig Dermatol

Neuroinflammation mechanisms of neuromodulation therapies for anxiety and depression.

Transl Psychiatry

Is rosacea a systemic disease?

Clin Dermatol

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.

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

Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Erythematotelangiectatic Rosacea

Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Erythematotelangiectatic Rosacea

Clinical Summary

What was studied

Key findings

Study limitations

Clinical implications

Related Questions