Effect of biodegradable microneedle acupuncture for symptom relief moderate or milder atopic dermatitis: a study protocol for a multicenter, randomized, sham-controlled trial

Atopic dermatitis (AD) has no definitive cure; therefore, alternative treatments should be developed. We have demonstrated in preliminary clinical trials that Biodegradable Microneedle Acupuncture (BMA) treatment improves symptoms and is safe for mild to moderate AD. The study focused on evaluating the effectiveness and safety of a new medical device called BMA for AD, while also assessing its cost-effectiveness. It also explored the gut microbiome of patients with AD before and after BMA treatment. This multicenter, participant-assessor-blinded, sham-controlled trial will be conducted from January 10, 2025, to January 10, 2026. In total, 184 participants with AD (n = 92 per group) will be recruited. Participants will be assigned randomly to two equal-sized groups: the BMA and sham groups. Treatment will be administered three times per weekduring the 4-week intervention phase. The primary outcome measure will be the objective SCORing Atopic Dermatitis index. Secondary outcome measures will include the Eczema Area and Severity Index, Dermatology Life Quality Index, Patient-Oriented Eczema Measure, and pruritus Visual Analog Scale scores. Other outcome measures will include gut microbiome, economic and safety evaluations. This study protocol will provide an important and thorough assessment of the effectiveness of BMA treatment in improving the symptoms of moderate or milder AD. In addition, we will evaluate the safety and costeffectiveness of BMA. We will also determine the link between AD and the microbiome. This clinical trial has been registered with the Korean Clinical Trial Registry (registration number: KCT0009870; date of registration: 25 October 2024).