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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

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Abstract

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).

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Availability of data and materials

All data generated or analyzed during this study are included in this published article.

Abbreviations

AD:

Atopic dermatitis

SC:

Stratum corneum

TEWL:

Transepidermal water loss

TDD:

Transdermal drug delivery

MN:

Microneedle

BHMN patch:

Biodegradable hyaluronic acid MN patch

NL patch:

Needleless patch

NDSUKH:

Naju Dongshin University Korean Medicine Hospital

L-SCORAD:

Local Scoring Atopic Dermatitis

VAS:

Visual analog scale

SCORAD:

Scoring atopic dermatitis

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Funding

This study was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health & Welfare, Republic of Korea (Grant No.: HI19C0553).

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Authors and Affiliations

  1. Department of Ophthalmology, Otolaryngology and Dermatology, College of Korean Medicine, Dongshin University, 120-9, Dongsindae-gil, Naju-si, Jeollanam-do, 58245, Republic of Korea

    Ji-Hoon Song & Soo-Yeon Park

  2. Raphas Co., Ltd., 62, Magokjungang 8-ro 1-gil, Gangseo-gu, Seoul, 07793, Republic of Korea

    Eun ** An, Chang Yub Sung & Do Hyeon Jeong

  3. College of Korean Medicine, Dongshin University, 120-9, Dongsindae-gil, Naju-si, Jeollanam-do, 58245, Republic of Korea

    Gihyun Lee

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Contributions

Conceptualization: S-YP; methodology: S-YP; formal analysis: GL; investigation: J-HS and S-YP; resources: DHJ; writing—original draft preparation: J-HS; writing—review and editing: S-YP and J-HS; visualization: J-HS; supervision: EJA, CYS, and S-YP; project administration: S-YP and DHJ; funding acquisition: DHJ. All authors have read and agreed to the published version of the manuscript.

Corresponding author

Correspondence to Soo-Yeon Park.

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The authors declare that they have no competing interests.

Ethics approval and consent to participate

This study was conducted according to the guidelines of the Declaration of Helsinki, and it was approved by the Institutional Review Board of the Naju Dongshin University Korean Medicine Hospital (Approval No. NJ-IRB-010). Informed consent was obtained from all subjects involved in the study.

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Song, JH., An, E.J., Sung, C.Y. et al. 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. Arch Dermatol Res 315, 569–581 (2023). https://doi.org/10.1007/s00403-022-02400-9

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