Acupuncture to reduce facial redness and flushing in treatment‑resistant rosacea.

A Randomized, Multicenter, Single-blind, Sham-controlled Clinical Trial on the Efficacy and Safety of Acupuncture in the Treatment of Refractory Rosacea.

This study will test whether acupuncture can reduce facial redness and flushing in adults whose rosacea has not improved with standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT07296497 on ClinicalTrials.gov

What this trial studies

This randomized, sham‑controlled trial will enroll 104 adults with refractory rosacea and randomly assign them 1:1 to electroacupuncture or sham acupuncture. The active group receives 20‑minute electroacupuncture sessions using continuous 1 Hz microcurrent across 16 sessions over 8 weeks, while the sham group receives noninvasive blunt‑tipped needle stimulation that does not penetrate the skin. The study includes a 1‑week baseline, an 8‑week treatment phase, and an 8‑week follow‑up with in‑person visits at weeks 0, 4, 8, and 12 and an online visit at week 16. The primary outcome is change in facial erythema and flushing episodes, and safety will be monitored throughout the 17‑week period.

Who should consider this trial

Good fit: Adults aged 18–65 with refractory rosacea who have had at least 12 weeks of conventional oral therapy (for example doxycycline) but still have persistent or recurrent erythema or flushing are the intended participants.

Not a fit: People who are pregnant or breastfeeding, those with mild rosacea that responds to standard care, or individuals unable to attend in‑person visits are unlikely to benefit from or be eligible for this trial.

Why it matters

Potential benefit: If effective, acupuncture could provide a non‑drug option to reduce persistent facial redness and flushing in people with treatment‑resistant rosacea.

How similar studies have performed: Small trials and case reports of acupuncture for rosacea and related facial redness suggest possible benefit, but high‑quality, sham‑controlled evidence is limited.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. Age between 18 and 65 years, inclusive, with no restriction on sex;
3. 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.

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
2. Patients with diabetes mellitus or moderate to severe systemic diseases affecting the liver, kidney, lung, or hematologic system;
3. Patients with depression or other psychiatric disorders;
4. Individuals with severe abnormal reactions to acupuncture (e.g., syncope during acupuncture, allergy to acupuncture needles);
5. Patients with rosacea accompanied by nasal hypertrophy or other facial dermatoses (such as seborrheic dermatitis, eczema) or facial manifestations of other systemic diseases (such as dermatomyositis, systemic lupus erythematosus);
6. Individuals with a bleeding tendency or coagulation disorders, or with skin damage, infection, or other lesions at the acupuncture sites;
7. Patients who discontinued oral antibiotics less than 1 month prior to enrollment; discontinued non-antibiotic oral medications less than 15 days prior (or isotretinoin less than 3 months prior); or discontinued topical medications less than 1 week prior;
8. Patients who are expected to be unable to comply with follow-up requirements;
9. Individuals who have participated in any other clinical trial within 1 month before screening (defined as having signed an informed consent form and received an investigational drug/device/placebo);
10. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.

Where this trial is running

Changsha, Hunan

• Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Ben Wang

Conditions Rosacea; rosacea; acupuncture