CD Formulation is a cosmetic testing center integrating testing and development, with the ability to conduct physical, chemical and microbiological testing, safety and efficacy evaluation testing, toxicology testing, etc. It basically covers the whole range of cosmetic products, providing technical support for cosmetic research and development as well as listing and registration.
Cosmetics with spot whitening effect, should be through the human efficacy evaluation test for efficacy claims evaluation. Cosmetic efficacy evaluation test should have a reasonable test program, the program design should be consistent with the principles of statistics, test data meet the statistical requirements, and in accordance with the requirements of the technical guidelines for cosmetic efficacy evaluation test. Human efficacy evaluation test and consumer use test should be completed before the necessary product safety evaluation to ensure that in normal, foreseeable circumstances shall not be hazardous to the human health of the subjects, all subjects should sign an informed consent form before carrying out the test.
Priority should be given to the back as the test site, and non-exposed areas such as thighs and upper arms can also be selected. The area of each darkening test area should be not less than 0.5 cm2 and should be located in each sample application area.
The visual assessment and instrumental test should be conducted in an environment with a temperature of 21±1℃ and a relative humidity of 50±10% RH. The visual assessment should also be conducted under constant light conditions, and subjects should adapt to these environmental conditions for at least 30 minutes before assessment and testing.
Volunteer subjects were recruited for enrollment as required and signed a written informed consent form. Prior to enrollment, subjects are asked a series of questions about their disease history, health status, etc. based on inclusion and exclusion criteria, while skin conformity assessment and skin color test screening of the subject area are performed and documented.
Eligible subjects enter the stage of establishing the human skin melanization model. First, the MED of the test site should be determined for each subject, and then each test area in the test site should be selected and irradiated once a day at the same irradiation point with a sunlight simulator at a dose of 0.75 times the MED for 4 consecutive days.
The skin was left untreated for 4 days after irradiation as a period of skin darkening.
On the 5th day after irradiation, the skin color of each test area was visually evaluated and examined by the skin color instrument, and the test areas with poor consistency should be excluded. Beginning on that day, apply the appropriate subject material to each darkening test area according to the randomization table.
The subjects were applied continuously for at least 4 weeks, and visual assessment and instrumentation of skin color should be performed and recorded at 1, 2, 3, and 4 weeks after application.
Data were statistically analyzed using statistical analysis software.
After the test is completed, the evaluation report on the efficacy of cosmetic lightening issued should generally include the following contents:
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