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

Inclusion Criteria:

1. Patients diagnosed with refractory rosacea, defined as those who have received atleast 12 weeks of conventional oral medication (such as doxycycline), with orwithout other treatments (e.g., topical medications or intense pulsed light [IPL]therapy), but remain treatment-resistant - characterized by no improvement oferythema by at least one CEA grade, persistent erythema ≥ grade 3, or recurrentflushing 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 arewilling 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 nearfuture;

2. Patients with diabetes mellitus or moderate to severe systemic diseases affectingthe 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 duringacupuncture, 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 systemicdiseases (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 (orisotretinoin less than 3 months prior); or discontinued topical medications lessthan 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 beforescreening (defined as having signed an informed consent form and received aninvestigational drug/device/placebo);

10. Any other condition that, in the opinion of the investigator, makes the participantunsuitable for enrollment.