An interventional study of Acupuncture and Sham Acupuncture in Rosacea, sponsored by Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
This study is a randomized, multicenter, sham-controlled clinical trial designed to evaluate the efficacy and safety of acupuncture for patients with refractory rosacea. A total of 104 participants will be enrolled and randomly assigned in a 1:1 ratio to the acupuncture group or the sham acupuncture group (52 participants in each group, regardless of sex). The primary aim is to determine whether acupuncture can effectively alleviate facial erythema and flushing episodes compared with sham stimulation.
Participants in the acupuncture group will receive electroacupuncture treatment using continuous waves at a frequency of 1 Hz, delivering microcurrent intensity comparable to human bioelectric levels for 20 minutes per session. Participants in the sham group will receive noninvasive stimulation with blunt-tipped needles that do not penetrate the skin. The study duration is 17 weeks in total, consisting of a 1-week baseline observation period, an 8-week treatment phase (16 treatment sessions in total), and an 8-week follow-up phase. Five in-person assessment visits will be conducted at weeks 0, 4, 8, and 12, followed by an online follow-up at week 16. The study will assess improvements in rosacea symptoms and monitor treatment safety throughout the study period.
Exclusion Criteria:
Device: Acupuncture
Procedure: Sham Acupuncture
The acupuncture sites are primarily located on the face, neck, and proximal limbs along major blood vessels. The specific acupoints include Jiquan (HT1), Yinlian (LR11), Weizhong (BL40), Chize (LU5), and facial Ashi points. The needles are inserted to a depth of 2-3 mm, retained, and stimulated with continuous waves at a frequency of 1 Hz for 20 minutes. Electrical stimulation is not applied to the facial Ashi points, where needles are retained only. The treatment course lasts for 8 weeks, with two sessions per week, for a total of 16 sessions.
Use blunt-tipped acupuncture needles to deliver sham stimulation. The blunt needles do not penetrate the skin. The treatment sites, needle retention time, and electrical stimulation frequency are identical to those in the acupuncture group. The treatment duration and frequency are also the same as in the acupuncture group.
proportion of successful treatment for rosacea erythema
The treatment is defined as successful when the Clinician's Erythema Assessment (CEA) score is ≤ 1 or has decreased by 2 points from baseline.
Time frame: week0，4，8，12
improvement in severity of rosacea flushing
This outcome is evaluated using the Rosacea Clinical Severity Assessment Scale - Patient Version (RCSAS-P), a patient-reported questionnaire capturing daily symptom burden. Patients score subjective symptoms-including facial flushing, erythema intensity, burning/stinging sensations, warmth, and overall discomfort-on structured rating items. The scale reflects symptom severity from the patient's perspective and complements clinician assessments.
Time frame: week0，4，8，12
improvement in burning sensation severity in rosacea
This outcome is evaluated using the Rosacea Clinical Severity Assessment Scale - Patient Version (RCSAS-P), a patient-reported questionnaire capturing daily symptom burden. Patients score subjective symptoms-including facial flushing, erythema intensity, burning/stinging sensations, warmth, and overall discomfort-on structured rating items. The scale reflects symptom severity from the patient's perspective and complements clinician assessments.
Time frame: week0，4，8，12
improvement in degree of telangiectasia in rosacea
This outcome is evaluated using the Rosacea Clinical Severity Assessment Scale - Patient Version (RCSAS-P), a patient-reported questionnaire capturing daily symptom burden. Patients score subjective symptoms-including facial flushing, erythema intensity, burning/stinging sensations, warmth, and overall discomfort-on structured rating items. The scale reflects symptom severity from the patient's perspective and complements clinician assessments.
Time frame: week0，4，8，12
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week0，4，8，12
Rosacea-Specific Quality of Life Questionnaire (RosQoL)
Time frame: week0，4，8，12
improvement in the number/frequency of weekly flushing episodes in rosacea
This outcome is evaluated using the Rosacea Diary, a structured patient-reported daily log designed to document symptom fluctuations. Participants record the presence, frequency, and severity of flushing episodes, as well as associated erythema, burning, stinging, and discomfort. The diary captures day-to-day variability and provides quantitative data on weekly flushing patterns and symptom burden.
Time frame: week0，4，8，12
Number of participants with treatment-related adverse events as assessed by the Rosacea Treatment-Related Adverse Event Recording Form (RTAERF)
Treatment-related adverse events (AEs) will be collected using the Rosacea Treatment-Related Adverse Event Recording Form (RTAERF), an investigator-developed safety assessment tool. The form captures all local and systemic AEs, including onset, duration, severity, relationship to the intervention, and outcome. AEs will be summarized as the number and proportion of participants experiencing at least one treatment-related AE during the study period. Serious adverse events (SAEs) will also be documented and reported separately.
Time frame: week0，4，8，12
Plan to share: No — Only aggregated statistical results will be shared through academic publication. Individual participant data will not be shared due to confidentiality and privacy protection requirements.
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Xiangya Hospital of Central South University