A Randomized, Multicenter, Single-blind, Sham-controlled Clinical Trial on the Efficacy and Safety of Acupuncture in the Treatment of Refractory Rosacea.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Xiangya Hospital of Central South University
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- proportion of successful treatment for rosacea erythema
Overview
Brief Summary
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.
Detailed Description
Participants in the acupuncture group will receive electroacupuncture treatment using continuous waves at a frequency of 1 Hz, delivering microcurrent intensity comparable to human bioelectric levels for 20 minutes per session. Participants in the sham group will receive noninvasive stimulation with blunt-tipped needles that do not penetrate the skin. The study duration is 17 weeks in total, consisting of a 1-week baseline observation period, an 8-week treatment phase (16 treatment sessions in total), and an 8-week follow-up phase. Five in-person assessment visits will be conducted at weeks 0, 4, 8, and 12, followed by an online follow-up at week 16. The study will assess improvements in rosacea symptoms and monitor treatment safety throughout the study period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
- •Patients with diabetes mellitus or moderate to severe systemic diseases affecting the liver, kidney, lung, or hematologic system;
- •Patients with depression or other psychiatric disorders;
- •Individuals with severe abnormal reactions to acupuncture (e.g., syncope during acupuncture, allergy to acupuncture needles);
- •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);
- •Individuals with a bleeding tendency or coagulation disorders, or with skin damage, infection, or other lesions at the acupuncture sites;
- •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;
- •Patients who are expected to be unable to comply with follow-up requirements;
- •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);
- •Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.
Arms & Interventions
acupuncture group
Intervention: Acupuncture (Device)
sham acupuncture group
Intervention: Sham Acupuncture (Procedure)
Outcomes
Primary Outcomes
proportion of successful treatment for rosacea erythema
Time Frame: week0，4，8，12
The treatment is defined as successful when the Clinician's Erythema Assessment (CEA) score is ≤ 1 or has decreased by 2 points from baseline.
Secondary Outcomes
- improvement in severity of rosacea flushing(week0，4，8，12)
- improvement in burning sensation severity in rosacea(week0，4，8，12)
- improvement in degree of telangiectasia in rosacea(week0，4，8，12)
- Pittsburgh Sleep Quality Index (PSQI)(week0，4，8，12)
- Rosacea-Specific Quality of Life Questionnaire (RosQoL)(week0，4，8，12)
- improvement in the number/frequency of weekly flushing episodes in rosacea(week0，4，8，12)
- Number of participants with treatment-related adverse events as assessed by the Rosacea Treatment-Related Adverse Event Recording Form (RTAERF)(week0，4，8，12)