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

NCT ID: NCT07296497

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2027-04-30

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.

Conditions

Rosacea

Keywords

rosacea; acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

acupuncture group

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

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 two sessions per week, for a total of 16 sessions.

sham acupuncture group

Group Type: SHAM_COMPARATOR

Sham Acupuncture

Intervention Type: PROCEDURE

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.

Interventions

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 two sessions per week, for a total of 16 sessions.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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;

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 are willing 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 near future;

2. Patients with diabetes mellitus or moderate to severe systemic diseases affecting the 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 during acupuncture, 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 systemic diseases (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 (or isotretinoin less than 3 months prior); or discontinued topical medications less than 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 before screening (defined as having signed an informed consent form and received an investigational drug/device/placebo);

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ben Wang

Role: CONTACT

Phone: 8613875885737

Email: wangben0804@163.com

Other Identifiers

202507085-2

Identifier Type: -

Identifier Source: org_study_id