A comparative study on a biodegradable hyaluronic acid microneedle patch with a needleless patch for dry skin in atopic dermatitis: a single-blinded, split-body, randomized controlled trial.

To overcome interruption of skin barrier in transdermal drug delivery, the microneedle (MN) patch penetrates the barrier by punching with its MNs. Setting a needleless patch (NL patch) as the control intervention, this study assessed the efficacy of a biodegradable hyaluronic acid MN patch (BHMN patch) for atopic dermatitis (AD) patients with dry skin. Similar two AD lesions were selected from the extremities of a participant. For one lesion, a BHMN patch was attached for 6-8 h on where an aroma cream was applied (BHMN patch group). Simultaneously, an NL patch was attached on the other lesion as in the BHMN patch group (NL patch group). For 2 weeks, the interventions were conducted 3 times a week. The local scoring AD (L-SCORAD) index, the visual analog scale for pruritus and skin dryness, skin hydration, the transepidermal water loss (TEWL), and safety were assessed. Fifteen participants finished this trial with no dropouts. Both groups improved the L-SCORAD index after 2 weeks (p < 0.05), but the score of the BHMN patch group decreased more than that of the NL patch group (p < 0.05). The other outcomes, except for the TEWL, also showed statistical significance in intragroup comparisons. Nevertheless, none of the other outcomes showed statistical significance in intergroup comparisons. The TEWL showed no statistical significance even in intragroup comparison. Recoverable minor adverse events were reported in three cases. Considering the result of L-SCORAD index, the BHMN patch may be effective for ameliorating AD. However, a large-scale confirmatory trial is necessary to reassess other outcomes.Trial Registration: This study was registered with the Clinical Research Information Service, Republic of Korea (Submitted date: 04/01/2022, Registered date: 23/02/2022, The first participant enrollment: 01/12/2021, Registration No. KCT0007037).