Effect of Biodegradable Microneedle Acupuncture in Mild to Moderate Atopic Dermatitis: a single-blinded randomized controlled pilot trial

Abstract

Objectives: The need for alternative therapies for atopic dermatitis (AD) has emerged due to the side effects of conventional therapies. Biodegradable microneedle acupuncture (BMA) is a novel medical device that overcame the shortcomings of traditional intradermal acupuncture (IDA), such as foreign body feeling and allergic dermatitis. This study aimed to evaluate the efficacy and safety of BMA for patients with Mild to Moderate AD compared with the IDA.

Methods: An assessor-blinded, parallel, non-superiority, randomized controlled pilot trial was conducted. Thirty adult participants were recruited from a single hospital and were equally divided into the experimental or control group. They were treated with BMA or IDA on both sides of LI11, ST36, and PC6 for four hours. Over four weeks, both interventions were performed eight times in total. The primary endpoint was the objective scoring AD (O-SCORAD) index. The secondary endpoints were visual analog scale (VAS) for itch and sleep disturbance, dermatology life quality index (DLQI), skin hydration, and transepidermal water loss (TEWL).

Results: Enrolled thirty participants completed the trial. After the trial, all endpoints remarkably improved compared with the baseline in both groups, except for the TEWL. Between the two interventions, there were no remarkable differences in the fourth week, except for the VAS score for itch and DLQI. No serious adverse events occurred during the study period.

Conclusion: Both BMA and IDA were effective in improving Mild to Moderate AD, and they were safe. BMA can be an alternative to conventional acupuncture for patients with sensitive skin, including metal allergies.

Keywords: atopic dermatitis; biodegradable microneedle acupuncture; efficacy; randomized controlled trial; thumbtack needle.

Figure 1

Participants were treated with each intervention. (a) The BMA, made from programed biodegrade material, 5 needles per patch, was attached to both sides of the PC6 acupoint of a male participant. (b) The IDA with the metal needle, was attached to the same acupoints of a female participant. (c) Three commonly targeted acupuncture points—LI11 (on the arm), ST36 (on the lower leg), and PC6 (on the forearm). BMA, biodegradable microneedle acupuncture; IDA, intradermal acupuncture.

Figure 2

Study schedule. *The visits are allowed to be scheduled on the same day: screening visit and visit 1, visits 8 and 9; ^†visit 9 was scheduled for within three days from when four weeks passed since visit 1. O-SCORAD, objective scoring atopic dermatitis; VAS, visual analog scale; DLQI, dermatology life quality index; TEWL, transepidermal water loss.

Figure 3

The CONSORT flowchart of the study. BMA-AD, treated with biodegradable microneedle acupuncture for atopic dermatitis; IDA-AD, treated with intradermal acupuncture for atopic dermatitis.

Figure 4

The results of the primary and secondary endpoints. Values were presented as mean ± standard deviation. (a) Objective scoring atopic dermatitis (O-SCORAD). (b) Visual analog scale (VAS) for itch. (c) VAS for sleep disturbance. (d) Dermatology life quality index (DLQI). (e) Skin hydration. (f) Transepidermal water loss (TEWL). BMA-AD, treated with biodegradable microneedle acupuncture for atopic dermatitis; IDA-AD, treated with intradermal acupuncture for atopic dermatitis. *p < 0.05 in intergroup comparisons; ^†p < 0.05 on comparing the result after two weeks with baseline; ^‡p < 0.05 on comparing the result after four weeks with baseline.