Actively Recruiting
A Randomized, Multicenter, Single-blind, Sham-controlled Clinical Trial on the Efficacy and Safety of Acupuncture in the Treatment of Refractory Rosacea
Led by Xiangya Hospital of Central South University · Updated on 2026-01-30
104
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of acupuncture on patients with refractory rosacea, a skin condition that causes persistent facial redness and flushing. This randomized, multicenter, sham-controlled clinical trial aims to determine whether acupuncture can effectively reduce facial erythema and flushing episodes compared to sham acupuncture. The study will enroll 104 participants aged 18 to 65 years who have not responded to conventional treatments. Participants will be randomly assigned to one of two groups: the acupuncture group or the sham acupuncture group. The acupuncture group will receive electroacupuncture treatment at specific points on the face, neck, and limbs with continuous waves at 1 Hz for 20 minutes per session, twice a week for 8 weeks (total of 16 sessions). The sham group will receive non-penetrating stimulation with blunt needles at the same locations and schedule, without electrical stimulation on facial points. The study consists of a 1-week baseline observation, an 8-week treatment phase, and an 8-week follow-up phase. Participants will attend five in-person visits at weeks 0, 4, 8, 12, and an online follow-up at week 16. During these visits, researchers will assess rosacea symptoms including redness, flushing severity, burning sensation, and telangiectasia using questionnaires and clinical evaluations. They will also monitor sleep quality and quality of life. Safety will be tracked through reports of treatment-related adverse events. The total participation duration is 17 weeks, including baseline, treatment, and follow-up periods.
CONDITIONS
Brief Title
Acupuncture for Refractory Rosacea: A Study on Its Effectiveness and Safety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with refractory rosacea who have had at least 12 weeks of conventional oral medication without sufficient improvement
- Age between 18 and 65 years, inclusive
- Ability to understand the study, voluntarily agree to participate, sign informed consent, and comply with study procedures and follow-up
You will not qualify if you...
- Women who are pregnant, breastfeeding, or planning pregnancy soon
- Patients with diabetes or moderate to severe systemic disease affecting liver, kidney, lung, or blood system
- Patients with depression or other psychiatric disorders
- Severe abnormal reactions to acupuncture (e.g., syncope, allergy)
- Rosacea with nasal hypertrophy, other facial dermatoses, or systemic disease facial symptoms
- Bleeding disorders or skin damage, infection, or lesions at acupuncture sites
- Recent discontinuation of oral antibiotics less than 1 month ago or other medications as specified
- Inability to comply with follow-up
- Participation in other clinical trials within 1 month before screening
- Any condition making participation unsuitable by investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo a 1-week baseline observation period before starting treatment.
1 visit (in-person) at week 0 for baseline assessment
Duration - 8 weeks
Participants receive either electroacupuncture or sham acupuncture treatment over 8 weeks, with two sessions per week.
16 treatment sessions and 3 in-person assessment visits at weeks 4 and 8
Duration - 8 weeks
Participants are followed for 8 weeks after treatment to assess long-term effects and safety.
2 in-person visits at weeks 12 and 16 (week 16 follow-up is online)
Trial Site Locations
Total: 1 location
1
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
B
Ben Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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