The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology (한방안이비인후피부과학회지)

The Society of Korean Medicine Ophthalmology, Otolaryngology & Dermatology (대한한방안이비인후피부과학회)
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Efficacy and Safety of a Biodegradable Hyaluronic Acid Microneedle Patch for Dry Skin in Atopic Dermatitis : A Single-blinded, Split-body, Randomized Controlled Trial

아토피피부염 피부건조 증상 개선에 대한 용해성 마이크로니들 패치의 유효성 및 안전성 평가 임상연구

  • Ji-Hoon, Song (Department of Ophthalmology, Otolaryngology & Dermatology, College of Korean medicine, Dongshin University) ;
  • Gi-Hyun, Lee (College of Korean medicine, Dongshin University) ;
  • Min-Yeong, Jung (Department of Ophthalmology, Otolaryngology & Dermatology, College of Korean medicine, Dongshin University) ;
  • Jung-Hwa, Choi (Department of Ophthalmology, Otolaryngology & Dermatology, College of Korean medicine, Dongshin University) ;
  • Soo-Yeon, Park (Department of Ophthalmology, Otolaryngology & Dermatology, College of Korean medicine, Dongshin University)
  • 송지훈 (동신대학교 한의과대학 한방안이비인후피부과학교실) ;
  • 이기현 (동신대학교 한의과대학) ;
  • 정민영 (동신대학교 한의과대학 한방안이비인후피부과학교실) ;
  • 최정화 (동신대학교 한의과대학 한방안이비인후피부과학교실) ;
  • 박수연 (동신대학교 한의과대학 한방안이비인후피부과학교실)
  • Received : 2023.01.16
  • Accepted : 2023.02.10
  • Published : 2023.02.25
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Abstract

목적 : 마이크로니들 패치는 피부장벽의 주요 구성성분인 각질층을 관통할 수 있어 일반적인 경피를 통한 약물 전달 수단보다 더 효율적으로 약물을 전달할 수 있다는 장점이 있어 다양한 분야에서 응용되고 있다. 본 임상연구는 아토피피부염 환자의 피부 건조 증상에 대하여 용해성 히알루론산 마이크로니들 패치와 외용제를 병행하여 용해성 마이크로니들 패치의 유효성과 안전성을 평가하였다. 방법 : 본 연구는 단일 기관, 연구자 주도, 평가자 눈가림, 인체 분할 연구로 설계된 무작위 배정 임상시험으로, 피부건조 증상이 있는 아토피피부염 환자 20명을 대상으로 임상연구를 수행하였다. 한 명의 피험자에서 2곳의 시험 병변을 선택한 후, 무작위 배정으로 각각 시험 병변과 대조 병변을 결정하여 2주 동안 매일 양측 병변에 모두 아로마 크림을 도포한 다음, 시험 병변에만 용해성 히알루론산 마이크로니들 패치를 추가로 부착하였다. 결과 : 1차 유효성 평가지표인 local scoring atopic dermatitis(L-SCORAD) index는 치료 후에 시험 병변이 대조 병변보다 유의성 있게 호전되었다. 2차 유효성 평가지표 중 피부 건조감 VAS와 피부 수분 함유량도 시험 병변이 대조 병변보다 유의성 있는 개선을 보였다. Investigator's Global Assessment scale, 소양감 VAS, 경피수분손실량에 있어서는 시험 병변과 대조 병변 모두 치료 후에 유의성 있게 호전되었으나, 두 병변 간의 차이에는 유의성이 없었다. 이상 반응은 나타나지 않았으므로 안전성도 확인되었다. 결론 : 용해성 히알루론산 마이크로니들 패치와 외용제 병행치료는 외용제만 사용하였을 때보다 L-SCORAD index 및 피부 건조감 VAS, 피부 수분 함유량에 있어서 아토피피부염의 증상을 유의성 있게 개선시켰다.

Keywords

Acknowledgement

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). The BHMN patch used in this study was provided free of charge by Raphas Co., Ltd.(Seoul, Republic of Korea).

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