Journal of the Society of Cosmetic Scientists of Korea (대한화장품학회지)

Society of Cosmetic Scientists of Korea (대한화장품학회)
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Investigation of the Study Plan and Statistical Method of Functional Cosmetics on Human Skin

기능성 화장품의 인체시험 설계 및 통계적용 방법에 대한 고찰

  • Seo, Young Kyoung (Dermapro Skin Research Center, Dermapro Co., LTD.) ;
  • Koh, Jae Sook (Dermapro Skin Research Center, Dermapro Co., LTD.) ;
  • Lee, Won Chul (Department of Preventive Medicine, College of Medicine, Catholic University of Korea)
  • 서영경 ((주)더마프로 피부과학연구소) ;
  • 고재숙 ((주)더마프로 피부과학연구소) ;
  • 이원철 (가톨릭대학교 의과대학 예방의학교실)
  • Received : 2012.10.10
  • Accepted : 2013.02.26
  • Published : 2013.06.30
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Abstract

In Korea, the human skin tests to evaluate the anti-wrinkles and whitening effect have been accomplished in accordance with the KFDA guideline. Regarding the data of the visual assessment and machinery evaluation of the results for the human skin test, unpaired t-test have been used in order to compare between the test and the control groups and paired t-test for the comparison of effects for before and after. Descriptive statistics such as frequency analyses was used for the questionnaire evaluation data. In many cases of the European and American clinical test centers, the methodology and the statistical analysis were similar to ours. But, the documentation obtained by repeated application from identical individual has high relation. For this reason, it is desirable to apply RM ANCOVA and RM ANOVA to a visual assessment and machinery evaluation. We suggested that RM ANCOVA and RM ANOVA is the new approach to statistical analysis of human test data of functional cosmetics.

국내의 주름개선 혹은 미백 효능을 평가하기 위한 인체시험 방법은 식약청 가이드라인에 근거하여 시행 되어왔으며, 인체시험에서 육안평가 및 기기평가 결과에 대해 시험군과 대조군 간의 효과를 비교하기 위해서 unpaired t-test를 주로 이용하였고, 시술 전후의 효과를 비교하기 위해서 paired t-test를 이용하였다. 설문평가 결과에 대해서는 빈도분석을 이용한 기술통계법이 이용되고 있다. 미국 및 유럽의 임상 평가기관에서도 이와 유사한 시험법 및 통계분석 방법을 이용하고 있다. 그러나 동일 개체에 대하여 처치를 반복 적용하여 얻은 자료는 서로 관련성이 높아 이를 감안한 분석법을 적용해야 한다. 따라서 본 연구에서는 화장품 분야에서는 처음으로 기능성 화장품 중 주름 개선 및 미백 효능 시험의 육안평가 및 기기평가 자료에 대해 repeated measures ANCOVA (RM ANCOVA)와 repeated measures ANOVA (RM ANOVA)를 적용하여 통계 방법의 타당성 여부를 검증함으로서 현재의 인체시험 방법에 적합한 새로운 통계분석 방법을 제시하였다.

Keywords

References

  1. 국내임상시험의 현황과 발전방안, 34th Forum on Health Industry Promotion, Korea Health Industry Development Institute (2003).
  2. 화장품안전성관리사업 연구보고서II. 식품의약품 안전청, 1(2) (2001).
  3. K. Katz, G. Crawford, D. Lu, J. Kantor, and J. Margolis, Statistical reviewing policies in dermatology journals: results of a questionnaire survey of editors, J. Am, Acad, Dermatol., 51(2), 234 (2004). https://doi.org/10.1016/j.jaad.2004.02.015
  4. D. Altman, Related Articles, The scandal of poor medical research. BMJ. 29, 283 (1994).
  5. H. Ahn, S. Kim, Y. Kye, Statistical Methods Used in Articles of the Korean Journal of Dermatology. Korean Journal of Dermatology, 44(3), 281 (2006).
  6. IEC, Anti-wrinkle effect. France (2001).
  7. RCTS Inc., Clinical efficacy evaluation of skin care product, containing indole-3-aceticacid, designed to reduce the appearance of surface fine lines and wrinkles. USA (1999).
  8. DERMSCAN, Evaluation, IN VIVO on Human Subjects, of the Anti-Wrinkle, Moisturizing and Firming Effects of a Product. FRANCE (2000).
  9. preDerm, Study Report-Marketing, Skin care homein- use. Germany (2004).
  10. LIPOTEC S.A., Study of anti-wrinkle effect of Argireline. Spain (2001).
  11. J. Cohen. Statistical Power Analysis. Current Directions in Psychological Science, 1(3), 98 (1992). https://doi.org/10.1111/1467-8721.ep10768783
  12. S. Nakagawa. A farewell to Bonferroni: the problems of low statistical power and publication bias. Behavioral Ecology, 15(6), 1044 (2004). https://doi.org/10.1093/beheco/arh107
  13. 박용규, 송혜향. 반복측정과 교차계획, 자료의 분석법. 자유 아카데미사, 서울 (1998).
  14. M. Lawrence, C. Friedman and D. Furberg, Fundamentals of Clinical Trials, Third Edition (1998).
  15. R. Carter, S. Sonne, and K. Brady. Practical considerations for estimating clinical trial accrual periods: application to a multi-center effectiveness study. BMC Med. Res. Methodol., 30, 11 (2005).
  16. M. Shermer. The Skeptic Encyclopedia of Pseudoscience 2 volume set. ABC-CLIO. p455 (2002).
  17. D. Sheskin. Handbook of Parametric and Nonparametric Statistical Procedures. 59, CRC Press, New York, Washington D.C. (2004).
  18. R. Carter, Application of stochastic processes to participant recruitment in clinical trials. Control Clin. Trials., 25(5), 429 (2004). https://doi.org/10.1016/j.cct.2004.07.002