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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Процедура 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.

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT07296497 · 202507085-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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