인체피부에서 화장품이나 화장품 원료의 안전성시험은 대체로 육안평가로 이루어져왔다. 하지만, 피부반응 초기의 미세한 변화에 대해서 육안으로는 감지하지 못하는 경우가 많다. 따라서, 본 연구에서는 수종의 화장품 원료에 의해 유발되는 홍반반응에 대해 육안평가뿐 아니라, 레이저도플러혈류이미지(LDPI) 측정장비를 이용한 혈류변화 측정, $Vapometer^{(R)}$를 이용한 경피수분손실량(TEWL) 측정, 분광광도계를 이용한 피부색 측정과 같은 기기평가를 병행하여 비교하였다. 30명의 건강한 여성 피험자를 대상으로 오일류 7종, 계면활성제류 6종, 보습제류 5종을 피험자의 등 부위에24 h 폐쇄첩포(D0)하여 피부반응을 유도하였고 첩포 제거 후 30 min (D1), 24 h (D2)에 육안평가와 기기평가를 각각 실시하였다. 육안평가 결과, 프로필렌글라이콜을 제외한 모든 오일류와 보습제류는 저자극 수준의 피부반응(반응도 0+ - 2.9+)을 보인 반면, 프로필렌글라이콜과 모든 계면활성제류는 중자극에서 강자극 수준의 피부반응(반응도 3+ - 5+)을 보였다. 기기측정 결과, 육안평가에서 저자극 범주의 피부반응에 대해서 혈류량이나 피부색보다 경피수분손실량이 가장 민감하게 피부변화를 감지하였다.
인체피부에서 화장품이나 화장품 원료의 안전성시험은 대체로 육안평가로 이루어져왔다. 하지만, 피부반응 초기의 미세한 변화에 대해서 육안으로는 감지하지 못하는 경우가 많다. 따라서, 본 연구에서는 수종의 화장품 원료에 의해 유발되는 홍반반응에 대해 육안평가뿐 아니라, 레이저도플러혈류이미지(LDPI) 측정장비를 이용한 혈류변화 측정, $Vapometer^{(R)}$를 이용한 경피수분손실량(TEWL) 측정, 분광광도계를 이용한 피부색 측정과 같은 기기평가를 병행하여 비교하였다. 30명의 건강한 여성 피험자를 대상으로 오일류 7종, 계면활성제류 6종, 보습제류 5종을 피험자의 등 부위에24 h 폐쇄첩포(D0)하여 피부반응을 유도하였고 첩포 제거 후 30 min (D1), 24 h (D2)에 육안평가와 기기평가를 각각 실시하였다. 육안평가 결과, 프로필렌글라이콜을 제외한 모든 오일류와 보습제류는 저자극 수준의 피부반응(반응도 0+ - 2.9+)을 보인 반면, 프로필렌글라이콜과 모든 계면활성제류는 중자극에서 강자극 수준의 피부반응(반응도 3+ - 5+)을 보였다. 기기측정 결과, 육안평가에서 저자극 범주의 피부반응에 대해서 혈류량이나 피부색보다 경피수분손실량이 가장 민감하게 피부변화를 감지하였다.
The safety of cosmetics or cosmetic ingredients on human skin is generally evaluated by visual assessment but some early subtle skin changes may not be noticed by the naked eyes. Thus, the present study was conducted to detect skin reactions induced by mildly irritating cosmetic ingredients by using...
The safety of cosmetics or cosmetic ingredients on human skin is generally evaluated by visual assessment but some early subtle skin changes may not be noticed by the naked eyes. Thus, the present study was conducted to detect skin reactions induced by mildly irritating cosmetic ingredients by using a laser Doppler perfusion imager (LDPI) method that measures blood flow, a $Vapometer^{(R)}$ that measure strans epidermal water loss (TEWL), and a spectrophotometer that measures the skin color as the erythema values ($a^*$). Visual assessment showed that all tested oils and humectants except propylene glycol belong to the low skin irritation ranges (grades 0+ to 2.9+) while all tested surfactants and propylene glycol belong to the moderate-to strong-skin irritation ranges (grades 3+ to 5+). Among three instrumental methods, TEWL assessment appeared to be more sensitive than spectrophotometric or LDPI method and suitable for the detection of subtle skin response invisible to the naked eye (grades 0+ to 2.9+). Skin reactions of grade 3+ to 5+ could be detected by all three instrumental methods. In conclusion, the current study suggested that the sub-clinical skin reactions due to mild irritants contained in cosmetics can be best assessed by TEWL measurements.
The safety of cosmetics or cosmetic ingredients on human skin is generally evaluated by visual assessment but some early subtle skin changes may not be noticed by the naked eyes. Thus, the present study was conducted to detect skin reactions induced by mildly irritating cosmetic ingredients by using a laser Doppler perfusion imager (LDPI) method that measures blood flow, a $Vapometer^{(R)}$ that measure strans epidermal water loss (TEWL), and a spectrophotometer that measures the skin color as the erythema values ($a^*$). Visual assessment showed that all tested oils and humectants except propylene glycol belong to the low skin irritation ranges (grades 0+ to 2.9+) while all tested surfactants and propylene glycol belong to the moderate-to strong-skin irritation ranges (grades 3+ to 5+). Among three instrumental methods, TEWL assessment appeared to be more sensitive than spectrophotometric or LDPI method and suitable for the detection of subtle skin response invisible to the naked eye (grades 0+ to 2.9+). Skin reactions of grade 3+ to 5+ could be detected by all three instrumental methods. In conclusion, the current study suggested that the sub-clinical skin reactions due to mild irritants contained in cosmetics can be best assessed by TEWL measurements.
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제안 방법
As a result of the visual assessment (Table 2), the tested cosmetic ingredients could be divided into non-irritation (no reaction, N. R), mild-irritation (1+ to 2.9+ grade), moderate-irritation (3.0+ to 4.9+ grade) and severe-irritation groups (above 5+ grade). Non-irritation group included three oils (HP, MS and CE) and three humectants (G, C-26 and PEG-400).
First, TEWL was measured with a VapoMeter® (Delfin, Technologies Ltd., Finland) to quantify the barrier status of the skin.
In this study, the skin reactions were measured using the following three instruments for instrumental assessments. First, TEWL was measured with a VapoMeter® (Delfin, Technologies Ltd.
Patch test was conducted on both volar forearms of the volunteers using IQ chambers® (Chemotechnique Diagnostics AB, Sweden).
The result of this measurement is given in units of g/m2⋅h. Second, skin color was assessed by colorimetric measurements made with a Spectrophotometer (CM2500d, Minolta, Japan), an instrument for use with well-reflected skin color. Measurement values were represented in L*, a*, and b*.
As in the cases associated with hyperkeratosis or scale caused by inflammaory reactions, the reations may affect the temperature, the skin color (a*) and the blood flow rate[14,15]. This study was conducted instrumental assessments to detect weak (sub-clinical) skin irritations that could not be observed by visual assessments. Skin reactions to mildly irritating cosmetic ingredients were monitored using a LDPI method that measures blood flow, a vapometer® that measures TEWL, and a spectrophotometer that measures the skin color as the erythema values (a*).
대상 데이터
Thirty healthy female volunteers between ages 20 and 49 participated in this study, with a mean age of 33.9 ± 8.0 years.
데이터처리
The rate of increase was analyzed as the different values calculated from the baseline (D0) and the arithmetical mean values (D1 and D2). Significant differences were determined by the Repeated Measures ANOVA using SPSS program (ver. 13, IBM Corp., USA).
이론/모형
The skin reactions were scored according to the system modified by the Frosch & Kligman[25] and CTFA guidelines[26].
Participation was completely voluntary. This study was conducted in compliance with the principles of Good Clinical Practice described in the Declaration of Helsinki[20].
성능/효과
Nonetheless it was suggested that use of these ingredients in cosmetics should be avoided or carefully controlled. In conclusion, this study demonstrated that instrumental methods may be useful to detect sub-irritation skin reactions developed by the mild irritants generally contained in cosmetics. TEWL assessment is considered to be the best way to evaluate skin reactions of oils and humectants.
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