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

Official title

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

Overview

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.

Interventions

• Device Acupuncture
  The acupuncture sites are primarily located on the face, neck, and proximal limbs along major blood vessels. The specific acupoints include Jiquan (HT1), Yinlian (LR11), Weizhong (BL40), Chize (LU5), and facial Ashi points. The needles are inserted to a depth of 2-3 mm, retained, and stimulated with continuous waves at a frequency of 1 Hz for 20 minutes. Electrical stimulation is not applied to the facial Ashi points, where needles are retained only. The treatment course lasts for 8 weeks, with
• Procedure Sham Acupuncture
  Use blunt-tipped acupuncture needles to deliver sham stimulation. The blunt needles do not penetrate the skin. The treatment sites, needle retention time, and electrical stimulation frequency are identical to those in the acupuncture group. The treatment duration and frequency are also the same as in the acupuncture group.

Primary outcome measures

• proportion of successful treatment for rosacea erythema [Time frame: week0，4，8，12]

Secondary outcome measures (7)

• improvement in severity of rosacea flushing [Time frame: week0，4，8，12]
• improvement in burning sensation severity in rosacea [Time frame: week0，4，8，12]
• improvement in degree of telangiectasia in rosacea [Time frame: week0，4，8，12]
• Pittsburgh Sleep Quality Index (PSQI) [Time frame: week0，4，8，12]
• Rosacea-Specific Quality of Life Questionnaire (RosQoL) [Time frame: week0，4，8，12]
• improvement in the number/frequency of weekly flushing episodes in rosacea [Time frame: week0，4，8，12]
• Number of participants with treatment-related adverse events as assessed by the Rosacea Treatment-Related Adverse Event Recording Form (RTAERF) [Time frame: week0，4，8，12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT07296497 · 202507085-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗