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Human Evaluation Test for Firming Efficacy of Cosmetics

According to the Standard for the Evaluation of Efficacy Claims of Cosmetics, cosmetics with firming efficacy (helps maintain skin firmness and elasticity) should be evaluated by means of human efficacy evaluation test/consumer use test/laboratory test (at least one item must be selected).


At present, China NMPA (National Medical Products Administration) has not yet issued a unified human efficacy evaluation method and standard for firming efficacy. The main human efficacy evaluation methods and standards referenced by industry testing institutions and laboratories are: T/TDCA 003-2021 Method for Assessment of Cosmetics Firmness Efficacy; T/GDCDC 020-2022 Test Method for Efficacy Measurement of Skin Firming Cosmetics Products; T/CAB 0152-2022 Seven Efficacy Test Methods for Anti-Wrinkle, Firming, Moisturizing, Oil Control, Repairing, Nourishing and Soothing of Cosmetics, etc.


This article mainly verifies the firming efficacy of cosmetics based on data such as skin elasticity, dermis thickness, and density.


Test instrument

Skin elasticity tester: Cutometer or its equivalent

Skin ultrasound diagnostic instrument: Ultrascan UC22 or its equivalent


Measurement index

Skin elasticity value and skin tightness value

Thickness and density of dermis


Test design

Select 30 qualified subjects, randomly select product application areas and blank control areas from the left and right face areas of the subjects, ensuring that each measurement area is at least 3cm*3cm.


Before using the test sample, measure three times at different locations within the measurement area of the sample application area and the control area, with a 3-minute interval between each measurement. The average values are taken as the initial value.


The subjects use the samples according to the instructions, and the application of the samples should fully cover each measurement area. The subjects return to the laboratory at the set measurement time point and measured 3 times at different locations within the measurement area, with a 3-minute interval between each measurement. The average values are taken as the measurement values.


Multiple measurement time points can be set according to product evaluation needs, and the entire testing cycle should be at least 2 weeks.


Data collection and analysis

Apply statistical analysis software for statistical analysis of test data, represented as mean ± standard deviation.


If the test data is a normal distribution, the t-test method should be used for statistical analysis; If the test data is a non-normal distribution, the rank sum test method should be used for statistical analysis.


A two-tailed test is used for all statistical methods, with a testing level of α=0.05.


Conclusion

Positive: There is a significant improvement in skin parameters measured by the test instrument before and after using the product (p<0.05), indicating that the test sample has a firming efficacy.


Negative: There is no significant improvement in skin parameters measured by the test instrument before and after using the product (p≥0.05), indicating that the test sample doesn’t have a firming efficacy.


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