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

The Society of Korean Medicine Ophthalmology, Otolaryngology & Dermatology (대한한방안이비인후피부과학회)
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Characteristics of Clinical Trials in Korea for Atopic Dermatitis - Focus on ClinicalTrials.gov Registered Clinical Trials -

식약처 승인 아토피 피부염 의약품 국내 임상 시험의 특성 - ClinicalTrials.gov 등록 임상시험을 중심으로-

  • Hwang, Mi-Lee (Department of Korean Medicine Ophthalmology & Otolaryngology & Dermatology, College of Korean Medicine, Daejeon University) ;
  • Ahn, Jae-Hyun (Department of Korean Medicine Ophthalmology & Otolaryngology & Dermatology, College of Korean Medicine, Daejeon University) ;
  • Jea, Ha-Kyung (Department of Korean Medicine Ophthalmology & Otolaryngology & Dermatology, College of Korean Medicine, Daejeon University) ;
  • Kim, Soo-Young (Department of Korean Medicine Ophthalmology & Otolaryngology & Dermatology, College of Korean Medicine, Daejeon University) ;
  • Jung, Hyun-A (Department of Korean Medicine Ophthalmology & Otolaryngology & Dermatology, College of Korean Medicine, Daejeon University)
  • 황미리 (대전대학교 대학원 한의학과 외관과학 교실) ;
  • 안재현 (대전대학교 대학원 한의학과 외관과학 교실) ;
  • 제하경 (대전대학교 대학원 한의학과 외관과학 교실) ;
  • 김수영 (대전대학교 대학원 한의학과 외관과학 교실) ;
  • 정현아 (대전대학교 대학원 한의학과 외관과학 교실)
  • Received : 2019.04.05
  • Accepted : 2019.04.24
  • Published : 2019.05.25
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Abstract

Objective : This study summarized the characteristics of clinical trials for atopic dermatitis medicines approved by the Ministry of Food and Drug Safety(MFDS). This study may be a reference for the design of clinical trials of atopic dermatitis herbal medicine treatment which may be carried out later. Method : The characteristics of the clinical trial were analyzed for clinical trials registered with ClinicalTrials.gov, CRIS, and the Korea Health Industry Development Institute among the clinical trial approval statuses posted on the website of the MFDS. Result : 1. Clinical trial drugs were developed in various formulations such as oral medicines, injections, dermatologic agents, and similar proportions. Relatively little clinical trials were found for herbal medicine. 2. In the control evaluation test, most of the treatments for the control group were performed with placebo using Vehicle. 3. In most clinical trials, one intervention group was in the form of a parallel assignment with only one treatment. 4. The age of the subjects was 11 out of 28 studies including minors, and clinical trials targeting minors were also found to be significant. 5. In the case of atopic dermatitis, the cases of subacute chronic or atopic dermatitis more than 6 months or more than 1 year were often used. 6. Most clinical trials were divided into mild to moderate atopic dermatitis or moderate to severe atopic dermatitis. The SCORAD index, EASI, IGA, BSA, and NRS were used as the evaluation criteria. 7. Regulations for the drugs used prior to the trial period for the treatment of atopic dermatitis vary somewhat from one clinical trial to another. 8. IGA was used most often as a primary efficacy tool, and SCORAD index, EASI, and NRS were also used.

Keywords

Table 5. Primary Efficacy Evaluation

OOBHC1_2019_v32n2_68_t0001.png 이미지

Table 1. Clinical Trials List and Designs.

OOBHC1_2019_v32n2_68_t0002.png 이미지

Table 2. Inclusion Criteria of Clinical Trials

OOBHC1_2019_v32n2_68_t0003.png 이미지

Table 3. Inclusion Criteria of Severity of Atopic dermatitis

OOBHC1_2019_v32n2_68_t0004.png 이미지

Table 4. Exclusion Criteria of Clinical Trials

OOBHC1_2019_v32n2_68_t0005.png 이미지

References

  1. Cho AR, Han SR, Park G, Seo S. Retrospective Study about the Effectiveness of Korean Medicine Treatment on 89 Severe Atopic Dermatitis Patients. J Korean Med Ophthalmol Otolaryngol Dermatol. 2016;29(2):161-79. https://doi.org/10.6114/jkood.2016.29.2.161
  2. Lee SE, Yoon HJ, Ko WS. Recent Trend and Proposal for Acupuncture Clinical Trial on Atopic Dermatitis. J Korean Med Ophthalmol Otolaryngol Dermatol. 2017;30(3):76-87. https://doi.org/10.6114/JKOOD.2017.30.3.076
  3. Kim EJ, Ri SH, Seo SC, Choung JT, Yoo Y. Prevalence of atopic dermatitis and its associated factors for elementary school children in Gyeonggi-do province. Allergy Asthma Respir Dis. 2016;4(5):346-53. https://doi.org/10.4168/aard.2016.4.5.346
  4. Min DL, Park EJ, Kang KH. Review of Clinical and Experimental Studies on External Application Treatment for Atopic Dermatitis in the Korean Literature. J Pediatrics of Korean Medicine. 2013;27(1):36-49. https://doi.org/10.7778/jpkm.2013.27.1.036
  5. Kwon HJ, Kim YJ, Jang SH, Bae BK, Youn HY, Lee HW. Stimulatory Effect of Staphylococcal Protein A on Inflammatory Response in Human HaCaT Keratinocytes. The Korean Journal of Microbiology. 2011;47(4):348-55.
  6. Kim GW, Bak JW, Sim BY, Kim DH. An experimental study for the development of prescription on atopic dermatitis. Kor. J. Herbology. 2014;29(4):13-20. https://doi.org/10.6116/KJH.2014.29.4.13
  7. Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermatovener. 1980;60(92):44-7.
  8. Gallant C, Kenny P. Oral glucocorticoids and their complications. A review. Journal of the American Academy of Dermatology. 1986;14(2):161-77. https://doi.org/10.1016/S0190-9622(86)70018-2
  9. Sowden JM, Berth-Jones J, Ross JS, Motley RJ, Marks R, Finlay AY, et al. Double-blind, controlled, cross-over study of cyclosporin in adults with severe refractory atopic dermatitis. Lancet. 1991;338(8760):137-40. https://doi.org/10.1016/0140-6736(91)90134-B
  10. Hwang SB, Park SM, Oh MJ, Kim HT. A Double-blind, Randomized, Placebocontrolled Intervention Study of the Efficacy and Safety of 'Atomento solution & cream' in patients with Atopic Dermatitis. J Korean Med Ophthalmol Otolaryngol Dermatol. 2009;22(2):223-37.
  11. Song YM. Legal Issues in Clinical Trial on Minor. Journal of The Korean Society of law and Medicine. 2016;17(2):125-44.
  12. Choi SY, Park KY, Li KS, Seo SJ, Kim KH, Kim DW, et al. Comparison of Severity Scoring Systems of Atopic Dermatitis. Korean J Dermatol. 2013;51(4):243-8.
  13. Futamura M, Leshem YA, Thomas KS, Nankervis H, Williams HC, Simpson EL. A Systematic Review of Investigator Global Assessment (IGA) in Atopic Dermatitis (AD) Trials: Many options, no Standards. J AM ACAD DERMATOL. 2016;74(2):288-94. https://doi.org/10.1016/j.jaad.2015.09.062