About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with refractory rosacea, defined as those who have received at least 12 weeks of conventional oral medication (such as doxycycline), with or without other treatments (e.g., topical medications or intense pulsed light [IPL] therapy), but remain treatment-resistant - characterized by no improvement of erythema by at least one CEA grade, persistent erythema ≥ grade 3, or recurrent flushing that affects quality of life (DLQI indicating at least a moderate impact); or patients who experience frequent relapses during the 12-week treatment period;

Age between 18 and 65 years, inclusive, with no restriction on sex;

Individuals who fully understand the purpose and significance of the study, voluntarily agree to participate, sign the informed consent form (ICF), and are willing to comply with all study procedures and follow-up requirements.

Disqualifiers

Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;

Patients with diabetes mellitus or moderate to severe systemic diseases affecting the liver, kidney, lung, or hematologic system;

Patients with depression or other psychiatric disorders;

Individuals with severe abnormal reactions to acupuncture (e.g., syncope during acupuncture, allergy to acupuncture needles);

Trial design

Design model

Parallel

Treatments tested in this trial

Acupuncture
Device
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.
Sham Acupuncture
Procedure/Surgery
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.

Treatment groups

104 Participants

are divided into 2 treatment groups

Group A: acupuncture groupExperimental treatment 1 intervention

Group B: sham acupuncture groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

2

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

3

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

4

Pittsburgh Sleep Quality Index (PSQI)

Time frame

week0，4，8，12

Acupuncture for Refractory Rosacea: A Study on Its Effectiveness and Safety

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts