Security Studies

It is a study to diagnose the presence or absence of a contact dermatitis or hypersensitivity to a given product, by performing an epicutaneous test using a Pach test, Open test, or Use test.

PACH TEST


It is a standardized procedure, in which the product to be tested is applied to the healthy skin of the volunteers, by means of occlusive chambers (Finn chamber).

Note: a chamber is left empty to dismiss possible sensitivity to the patch. 24 hours later, specialized professional physicians in charge open them and, after 30 minutes, they verify the absence or presence of erythema and its degree of intensity.

Note: The application of the product and subsequent observation of the skin condition can be performed as many times as necessary, according to the protocol.

PACH TEST


It is a standardized procedure, in which the product to be tested is applied to the healthy skin of the volunteers, by means of occlusive chambers (Finn chamber).

Note: a chamber is left empty to dismiss possible sensitivity to the patch. 24 hours later, specialized professional physicians in charge open them and, after 30 minutes, they verify the absence or presence of erythema and its degree of intensity.

Note: The application of the product and subsequent observation of the skin condition can be performed as many times as necessary, according to the protocol.

OPEN TEST


This test is undergone when, due to a particular characteristic of the product, a study through occlusion test cannot be conducted. It consists of the single or repeated application of the product on the inner forearm area, around the eye area, perioral area, or the area of use.

Specialized professional physicians in charge evaluate the skin response of the volunteers after 30 minutes, 24 hours, and 48 hours following the application of the product to be tested,


Based on the data obtained, a medical report is prepared after the evaluation of the product and its skin compatibility.

OPEN TEST


This test is undergone when, due to a particular characteristic of the product, a study through occlusion test cannot be conducted. It consists of the single or repeated application of the product on the inner forearm area, around the eye area, perioral area, or the area of use.

Specialized professional physicians in charge evaluate the skin response of the volunteers after 30 minutes, 24 hours, and 48 hours following the application of the product to be tested,


Based on the data obtained, a medical report is prepared after the evaluation of the product and its skin compatibility.

USAGE TEST


It is an acceptability study that specialized professional physicians develop and control throughout the entire period. The professionals assess reactions, discomfort, and/or cumulative irritations associated with the application of the product under study for a minimum period of 2 to 4 weeks under normal conditions of use in healthy volunteers, preceded by a ‘Patch Test’ with negative results.

Additionally, the volunteers complete questionnaires in brief interviews to provide their feedback on the usage of the product as indicated. After analyzing all the data obtained during the study, the conclusion is documented in a report

USAGE TEST


It is an acceptability study that specialized professional physicians develop and control throughout the entire period. The professionals assess reactions, discomfort, and/or cumulative irritations associated with the application of the product under study for a minimum period of 2 to 4 weeks under normal conditions of use in healthy volunteers, preceded by a ‘Patch Test’ with negative results.

Additionally, the volunteers complete questionnaires in brief interviews to provide their feedback on the usage of the product as indicated. After analyzing all the data obtained during the study, the conclusion is documented in a report