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