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

The Society of Korean Medicine Ophthalmology, Otolaryngology & Dermatology (대한한방안이비인후피부과학회)
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A Clinical Study for the Efficacy and Safety of Functional Cosmetics Containing Humulus japonicus Extract in Patients with Dry Skin due to Mild Atopic Dermatitis

아토피성 피부로 건조함을 가진 대상자에 대한 환삼덩굴추출물 함유 기능성 화장품의 유효성 및 안전성을 평가하기 위한 임상적 연구

  • Park, Hye-Su (Dept. of Korean Medical Ophthalmology & Otolaryngology & Dermatology, College of Korean Medicine, Semyung University) ;
  • Kim, Yong-Min (Dept. of Cosmetic Science & Beauty Biotechnology, Semyung University) ;
  • Kim, Hee-Tack (Dept. of Korean Medical Ophthalmology & Otolaryngology & Dermatology, College of Korean Medicine, Semyung University)
  • 박혜수 (세명대학교 한의과대학 한방안이비인후피부과학교실) ;
  • 김용민 (세명대학교 한방화장품과학과) ;
  • 김희택 (세명대학교 한의과대학 한방안이비인후피부과학교실)
  • Received : 2019.04.05
  • Accepted : 2019.05.02
  • Published : 2019.05.25
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Abstract

Objectives : The purpose of this study is to confirm the Efficacy and Safety of "Functional cosmetics containing Humulus japonicus Extract" on dry skin due to mild atopic dermatitis. Methods : A total of 48 patients who visited Semyung Oriental Medical Center from March 20th, 2018 to July 5th, 2018 were included in the study. In this study, the patients were treated with Functional cosmetics containing Humulus japonicus Extract and positive control group. For 6 weeks of gross examination, instrumental assessment were made before and after the study to evaluate how well the products for treatment group with positive control products for control group in recovering the dry skin barriers by mild atopic dermatitis. Results : 1. In the primary endpoint, Skin Hydration showed a statistically significant increase and Transepidermal Water Loss(TEWL) showed a statistically significant decrease in treatment group between Baseline and 6 weeks. 2. In the secondary endpoint, Skin Hydration showed a statistically significant increase in treatment group between Baseline and 3 weeks, but TEWL showed no statistical significance. 3. In the secondary endpoint, Skin Hydration showed a statistically significant increase in treatment group between 3 weeks and 6 weeks, but TEWL showed no statistical significance. 4. In the secondary endpoint, Change of Skin Hydration and TEWL between treatment and control group showed a statistical significance in 6 weeks. 5. In the secondary endpoint, Change of Skin Hydration of 1cm below the medial aspect of the elbow between treatment and control group showed a statistical significance in 3 weeks. 6. In the secondary endpoint, Change of Skin Hydration between treatment and control group showed a statistical significance in 3 weeks and 6 weeks except Center between the medial aspect of the elbow and the wrist in 3 weeks, and Change of TEWL between treatment and control group showed a statistical significance in 6 weeks. 7. To evaluate the safety of the products for the human body, Adverse events, EASI Score, Itching Symptoms Assessment, vital sign check were conducted; There were no severe adverse events during this study. And both experimental group and control group showed no abnormal level. Therefore, it is suggested that products, if used for certain period, should be safe for the human body. Conclusions : According to the above experiments, it is suggested that "Functional cosmetics containing Humulus japonicus Extract" should be effective for dry skin due to mild atopic dermatitis.

Keywords

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Fig. 1. Change of Skin Hydration between Treatment Group and Control Group in Baseline and 6 weeks(1㎝ below the medial aspect of the elbow)

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Fig. 2. Change of Skin Hydration between Treatment Group and Control Group in Baseline and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Fig. 3. Change of Transepidermal Water Loss (TEWL) between Treatment Group and Control Group in Baseline and 6 weeks(1㎝ below the medial aspect of the elbow)

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Fig. 4. Change of Transepidermal Water Loss TEWL) between Treatment Group and Control Group in Baseline and 6 weeks Center between the medial aspect of the elbow and the wrist)

Table 1. Composition of PB301 lotion and Positive Control

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Table 2. Schedule of Clinical Trial

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Table 3. Distribution Chart of Participants

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Table 4. Distribution of Sex, Antecedent Drug, Age, Height and Weight

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Table 5. Change of Skin Hydration between Baseline and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 6. Change of Skin Hydration between Baseline and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 7. Change of Transepidermal Water Loss(TEWL) between Baseline and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 8. Change of Transepidermal Water Loss(TEWL) between Baseline and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 9. Change of Skin Hydration in Treatment Group between Baseline and 3 weeks(1㎝ below the medial aspect of the elbow)

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Table 10. Change of Skin Hydration in Treatment Group between Baseline and 3 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 11. Change of Transepidermal Water Loss(TEWL) in Treatment Group between Baseline and 3 weeks(1㎝ below the medial aspect of the elbow)

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Table 12. Change of Transepidermal Water Loss(TEWL) in Treatment Group between Baseline and 3 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 13. Change of Skin Hydration in Treatment Group between 3 weeks and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 14. Change of Skin Hydration in Treatment Group between 3 weeks and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 15. Change of Transepidermal Water Loss(TEWL) in Treatment Group between 3 weeks and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 16. Change of Transepidermal Water Loss(TEWL) in Treatment Group between 3 weeks and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 17. Change of Skin Hydration between Treatment Group and Control Group in Baseline and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 18. Change of Skin Hydration between Treatment Group and Control Group in Baseline and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 19. Change of Transepidermal Water Loss(TEWL) between Treatment Group and Control Group in Baseline and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 20. Change of Transepidermal Water Loss(TEWL) between Treatment Group and Control Group in Baseline and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 21. Change of Skin Hydration between Treatment Group and Control Group in Baseline and 3 weeks(1㎝ below the medial aspect of the elbow)

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Table 22. Change of Skin Hydration between Treatment Group and Control Group in Baseline and 3 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 23. Change of Transepidermal Water Loss(TEWL) between Treatment Group and Control Group in Baseline and 3 weeks(1㎝ below the medial aspect of the elbow)

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Table 24. Change of Transepidermal Water Loss(TEWL) between Treatment Group and Control Group in Baseline and 3 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 25. Change of Skin Hydration between Treatment Group and Control Group in 3 weeks and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 28. Change of Transepidermal Water Loss(TEWL) between Treatment Group and Control Group in 3 weeks and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 29. Change of Skin Hydration between Treatment Group and Control Group in Baseline, 3 weeks and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 26. Change of Skin Hydration between Treatment Group and Control Group in 3 weeks and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 27. Change of Transepidermal Water Loss(TEWL) between Treatment Group and Control Group in 3 weeks and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 30. Change of Skin Hydration between Treatment Group and Control Group in Baseline, 3 weeks and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 31. Change of Transepidermal Water Loss(TEWL) between Treatment Group and Control Group in Baseline, 3 weeks and 6 weeks(1㎝ below the medial aspect of the elbow)

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Table 32. Change of Transepidermal Water Loss(TEWL) between Treatment Group and Control Group in Baseline, 3 weeks and 6 weeks(Center between the medial aspect of the elbow and the wrist)

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Table 33. Adverse Events

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Table 34. Change of EASI Score

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Table 35. Change of itching Symptoms

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Table 36. Change of the Frequency of Itching Symptoms

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Table 37. Change of the Duration of itching Symptoms

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Table 38. Change of Systolic Blood Pressure

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Table 39. Change of Diastolic Blood Pressure

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Table 40. Change of Pulse

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Table 41. Change of Body Temperature

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