Device-Free Auricular Acupressure for Rosacea: A Randomized Clinical Trial.

Importance

Transcutaneous auricular vagus nerve stimulation is effective for rosacea. However, its neuroimmunomodulatory effects lack sham-controlled serum biochemical evidence, and specialized device reliance limits its clinical popularization.

Objective

To evaluate the clinical efficacy of device-free auricular acupressure for rosacea and verify its neuroimmunomodulatory effects using serum biomarkers and immediate vascular imaging in a sham-controlled trial.

Design, setting, and participants

This single-center, randomized, sham-controlled, assessor-masked trial was conducted in the Dermatology Outpatient Department of the Second Affiliated Hospital of Xi'an Jiaotong University from October 2025 to May 2026 and included 204 patients with rosacea who were receiving standard first-line treatment. Participants were assigned in a 1:1 ratio using block randomization. Data analysis was initiated in May 2026.

Interventions

The active acupressure group received a Vaccaria segetalis seed on the bilateral cavum conchae (innervated by the auricular vagus branch), while the sham group received a seed on the auricular tubercle superior margin (pure somatosensory innervation). Participants performed acupressure 3 times daily for 30 seconds, with extra pressing allowed during acute flare-ups. The intervention lasted 8 weeks. Serum levels of cathelicidin antimicrobial peptide (LL-37), calcitonin gene-related peptide (CGRP), tumor necrosis factor α (TNF-α), and interleukin (IL) 6 were measured at baseline and week 8. Multispectral imaging was performed at baseline and week 4 to assess immediate vascular responses.

Main outcomes and measures

The primary outcome was treatment success, defined as an Investigator Global Assessment (IGA) score of 0 or 1 at week 8. The number needed to treat was calculated from absolute risk difference.

Results

The 204 participants were equally divided into 2 groups (102 each; active acupressure: mean [SD] age, 32.51 [10.60] years, 86 female individuals [84.3%]; sham acupressure: mean [SD] age, 30.82 [9.32] years, 86 female individuals [84.3%]). At week 8, the active acupressure group had a higher IGA success rate (58 [56.9%] vs 36 [35.3%]; relative risk, 1.61; 95% CI, 1.18-2.20; P = .003; number needed to treat, 5). Serum LL-37, CGRP, TNF-α, and IL-6 levels decreased more significantly in the active acupressure group. The immediate vascular improvement rate was 59.3% vs 7.4% (P < .001). At week 20, the active acupressure group maintained significantly lower IGA and Clinical Erythema Assessment scores. No serious adverse events occurred.

Conclusions and relevance

This randomized clinical trial found that device-free, on-demand intervention yielded substantial additional clinical benefits when combined with standard first-line therapy and established early sham-controlled, serum-based evidence for its neuroimmunomodulatory mechanism, potentially offering a strategy for self-management of rosacea.

Trial registration

Chinese Clinical Trial Registry Identifier: ChiCTR2500110787.