# US 2025/0375149 A1 · Method for improving the real-world skin sensitization impact of formulated products > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2025/0375149 A1 - Document ID: US20250375149A1 - Status: Published application - Kind: A1 - Application number: 18/876,799 - Filed: 2023-07-07 - Published: 2025-12-11 - Earliest claimed: 2022-07-07 - Assignees: Kenvue Brands LLC - Applicants: Kenvue Brands LLC - Inventors: Ladan Fakhrzadeh; Evren Atillasoy; James P. Bowman; Michael Cork; Alain Khaiat; Tony J. McGuire; Otto Mills; Teginder Singh - Web page: https://patentgrep.com/patent/US20250375149A1 ## CPC - A61B 5/411: {Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance} - G16H 50/00: ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics - A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor} - G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A method of predictively assessing skin sensitization of a personal care product formulation includes: calculating an upper confidence limit at a desired confidence level from multiple physical tests for skin sensitization of each of the ingredients in the personal care product formulation to define calculated skin sensitization values for the respective ingredients; applying at least one safety factor to at least one of the calculated skin sensitization values for the ingredients to define adjusted skin sensitization values for the respective ingredients; summing the adjusted skin sensitization values of the ingredients to define a total sensitization of the personal care product formulation; and comparing the total sensitization to a target product sensitization for the personal care product formulation. Such personal care product formulations do not require further testing and are capable of application to skin by users. Predictive systems and methods of preparing a personal care products are also disclosed. ## Claims ### Claim 1 A method of predictively assessing skin sensitization of a personal care product formulation including a plurality of ingredients, the method comprising: calculating an upper confidence limit at a desired confidence level from multiple physical tests for skin sensitization of each of the ingredients in the personal care product formulation in order to define calculated skin sensitization values for the respective ingredients; applying at least one safety factor to at least one of the calculated skin sensitization values for the ingredients to define adjusted skin sensitization values for the respective ingredients; summing the adjusted skin sensitization values of the ingredients to define a total sensitization of the personal care product formulation; and comparing the total sensitization to a target product sensitization for the personal care product formulation, wherein the product formulation for the personal care product formulation does not require further testing and is capable of application to skin by users when the total sensitization is less than the target product sensitization. ### Claim 2 (depends on 1) The method of claim 1, wherein the skin sensitization of each of the ingredients is defined as the percentage of subjects having an allergic response to physical allergic tests. ### Claim 3 (depends on 2) The method of claim 2, wherein the physical allergic tests are human repeat insult tests. ### Claim 4 (depends on 1) The method of claim 1, further comprising: setting an initial sensitization target for the personal care product formulation; and obtaining the skin sensitization of each of the ingredients from a computer database having multiple test results for each ingredient. ### Claim 5 (depends on 4) The method of claim 4, wherein the initial sensitization target is about 0.2 percent or less than 0.2 percent. ### Claim 6 (depends on 1) The method of claim 1, wherein the target product sensitization is about 0.1 percent or less than 0.1 percent. ### Claim 7 (depends on 1) The method of claim 1, further comprising selecting the ingredients that have used in multiple personal care products. ### Claim 8 (depends on 1) The method of claim 1, wherein the step of selecting ingredients further comprises selecting ingredients that have used in about ten or more than ten different personal care products. ### Claim 9 (depends on 1) The method of claim 1, further comprising selecting the ingredients that have been tested on a plurality of subjects. ### Claim 10 (depends on 9) The method of claim 9, wherein the plurality of subjects is about 2000 subjects or greater than 2,000. ### Claim 11 (depends on 1) The method of claim 1, wherein the desired confidence level is at least 95%. ### Claim 12 (depends on 1) The method of claim 1, wherein the multiple physical tests comprise tests on about ten or more than ten different personal care products, and tests on about 2000 subjects or greater than 2000 subjects. ### Claim 13 (depends on 1) The method of claim 1, further comprising applying a product usage factor to the calculated skin sensitization values for the ingredients; wherein the product usage factor is based on an estimated amount of product to be used and an estimated area of product use. ### Claim 14 (depends on 13) The method of claim 13, wherein the product usage factor is a ratio of an estimated daily use in grams over an estimated application surface area in square-centimeters. ### Claim 15 (depends on 1) The method of claim 1, wherein the step of applying at least one safety factor comprises multiplying the at least one calculated skin sensitization value for at least one of the ingredients by the at least one safety factor, or the step of applying the at least one safety factor comprises multiplying the adjusted skin sensitization values for each of the ingredients by the at least safety factor. ### Claim 16 (canceled). ### Claim 17 (depends on 15) The method of claim 15, wherein the at least one safety factor has a value of greater than one. ### Claim 18 (depends on 1) The method of claim 1, wherein the at least one safety factor is selected from safety factors selected from the group consisting of factors based on (a) impairment to skin barrier function, (b) based on product delivery effecting skin occlusion and/or based on occlusive nature application site, (c) based potential for pre-conditioned primed immune skin having potential for activated inflammatory response, and combinations thereof. ### Claim 19 (depends on 18) The method of claim 18, wherein, if applied, the safety factor based on impairment to skin barrier function is about 5 or greater than 5, the safety factor based on product delivery effecting skin occlusion and/or based on occlusive nature application site is about 5 or greater than 5, and the safety factor based potential for pre-conditioned primed immune skin having potential for activated inflammatory response is about 2 or greater than 2. ### Claim 20 A system to predictively assess skin sensitization of a personal care product formulation including a plurality of ingredients, the system comprising: a computing device; a memory storing instructions that, when executed by the computing device, cause the computing device to perform operations comprising: calculating an upper confidence limit at a desired confidence level from multiple tests for skin sensitization of each of the ingredients in the personal care product formulation in order to define calculated skin sensitization values for respective ingredients; applying at least one safety factor to the calculated skin sensitization values for the ingredients to define adjusted skin sensitization values for the respective ingredients; summing the adjusted skin sensitization values of the ingredients to define a total sensitization of the personal care product formulation; and comparing the total sensitization to a target product sensitization for the personal care product formulation, wherein the product formulation does not require further testing and is capable of application to skin by users when the total sensitization is less than the target product sensitization. ### Claim 21 A method of preparing a personal care product comprising: selecting a plurality ingredients for use in a personal care product formulation; calculating an upper confidence limit at a desired confidence level from multiple physical tests for skin sensitization of each of the ingredients in the personal care product formulation in order to define calculated skin sensitization values for the respective ingredients; applying at least one safety factor to at least one of the calculated skin sensitization values for the ingredients to define adjusted skin sensitization values for the respective ingredients; summing the adjusted skin sensitization values of the ingredients to define a total sensitization of the personal care product formulation; comparing the total sensitization to a target product sensitization for the personal care product formulation; and if the total sensitization is less that the target product sensitization, combining the ingredients to form the personal care product, wherein the product formulation for the personal care product formulation does not require further testing and is capable of application to skin by users.