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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Ben Wang
• Email: wangben0804@163.com
• Phone: 8613875885737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.