Dermatological Test - Patch Test (In Vivo)

DERMATOLOGICAL TESTING ON COSMETIC PRODUCTS (Patch test) (in vivo)

Dermatological testing is a test performed on volunteers to evaluate the irritation potential of a cosmetic product, in line with ethical principles for medical research.

In vivo ⦁ clinical tests on volunteers are carried out by experts in the field (e.g. dermatologist) in accordance with the Declaration of Helsinki (ethical principles for medical research on human subjects).

Interlaboratory reproducibility of in vivo patch tests is not available. Human patch test control data must be verifiable for classification acceptance.

WHAT DOES “DERMATOLOGICALLY TESTED” MEAN?
The phrase "dermatologically tested" means that a product or substance has been tested on the skin and reviewed by dermatologists. Such tests are usually performed to evaluate the safety and effectiveness of the use of products such as skin products, cosmetics on surfaces that come into contact with the skin.

The phrase "dermatologically tested" is used to indicate that the product does not cause any adverse effects or irritation on the skin and is approved by dermatologists. Such tests are performed to determine whether the product causes undesirable effects such as allergic reactions, irritation, redness when in contact with the skin.

WHAT IS THE PREREQUISITE FOR TESTED PRODUCTS?
Before any volunteer is exposed to the products to be tested, a safety assessment, including relevant testing, must be carried out. Studies can be conducted on volunteers with products that do not pose any risk and whose safety evaluation has been completed.

HOW TO APPLY DERMATOLOGICAL TEST?
Generally, easy and comfortable places such as the forearm and back are preferred for the test. When applying tests, it should be applied to an area that is relatively hair-free.
1- The patch (adhesive tape [“chamber]) where the product is injected is lifted from its protective corner.
2- The test material is glued to the back area.
3- After the application, the area around the test material is marked and numbered.
4- After 48 hours, the test material is removed and the test area is marked with a pencil and evaluated after 30 minutes.
5- The test area is re-evaluated at 72 and/or 96 hours. Evaluation only at the 48th hour is not sufficient. In order to detect late reactions, second and/or third evaluations must be made at the 72nd and/or 96th hour.

INTERPRETATION AND CLASSIFICATION OF DERMATOLOGICAL TEST DATA
The results are calculated by the Expert Dermatologist with the data of the tested cosmetic product. Based on the resulting data, the product is classified.

Not an irritant/cause of irritation
Very mild irritation/Cause of very mild irritation
Some mild irritation/Minor cause of irritation
Moderate to mild irritation/Moderate cause of irritation
Cause of irritation
Very irritating / Highly irritating

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Dermatological Test - Patch Test (In Vivo)