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Clinical Safety Evaluation of L’ACRIMA Skincare ProductsL’ACRIMA CATECHIN ACTIVE NIGHT CREAM L’ACRIMA CATECHIN ACTIVE DAY CREAM L’ACRIMA CATECHIN ACTIVE EYE CREAM The objective of these studies was to determine the irritation and/or sensitization potential of the test articles after repeated application under occlusive patch test conditions to the skin of human subjects. Ethical Conduct of the Study: The studies were conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in Title 21 of the U.S. Code of Federal Regulations (CFR), the Declaration of Helsinki and/or Essex Testing Clinic (ETC) Standard Operating Procedures. Subject Information and Consent: The study was conducted in compliance with CFR Title 21, Part 50 (Informed Consent of Human Subjects). Informed Consent was obtained from each subject in the study and documented in writing before participation in the study. A copy of the Informed Consent was provided to each subject. Test Material: The test articles used in the study were provided by: The American Catechin Research Institute & Laboratory,Malibu, California Test Subjects: L’ACRIMA Catechin Active Day Cream - a total of 53 subjects, 11 males and 42 females ages 20 to 68 years, were empaneled for this test L’ACRIMA Catechin Active Night Cream -a total of 55 subjects, 14 males and 41 females ages 18 to 69 years, were empaneled for this test L’ACRIMA Catechin Eye Repair Cream - a total of 55 subjects, 14 males and 41 females ages 18 to 69 years, were empaneled for this test The subjects chosen were dependable and ale to read and understand instructions. The subjects did not exhibit any physical or dermatological condition that would have precluded application of the test articles or determination of potential effects of the test articles. Results: There was no skin reactivity on any subject at any time during the study. Conclusions: Under the conditions of a repeated insult (occlusive) patch test procedure, Test Articles: L’ACRIMA Catechin Active Day Cream L’ACRIMA Catechin Active Night Cream L’ACRIMA Catechin Eye Repair Cream The creams were “ Dermatologist Tested” and did not induce skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects. Note: For more in depth information on these tests please click here. |
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