Clinical Study Types

Before an active or product is ready for exposure to the market it needs to go through various studies to ensure that it is safe for use and to determine that it does what it is meant to do. When performing tests and clinical studies, there are various methods that can be used to provide results. Below are different types of studies that are used to test different actives and ingredients that go into cosmetic products. The testing phase is one of the most important ones as all products must be safe to be used on humans. As such there are multiple studies to the testing phase. These studies are the In Tubo, In Vitro and In Vivo studies.

In Tubo Study

As the name implies, this study involves the use of a tube in the method. The product or active is placed in a test tube. Once in the test tube, the product is then exposed to various conditions while in the isolated system. Such conditions can include but are not limited to change in temperature, exposure to moisture, exposure to air, oils usually found on the skin and more. With each condition that the samples have been exposed to, the results will be analysed. The changes will be recorded as well as what possible side effects may be caused by these changes if any and how to avoid them if possible.

The exposure to various conditions is in order to determine the possible changes of the product in an isolated system before it comes into contact with humans. It is crucial as it may be possible that a skin treatment may undergo a reaction when exposed to heat causing it to be carcinogenic. It is essential to perform this step to avoid harming people.

In Vitro Study

This study is usually performed after the In Tubo study.  During the In Vitro study, the active or product is applied to a layer of artificial skin. This is done in order to determine the effects of the skin treatment on human skin before it is applied to living human skin. Thanks to modern technology, the use 3D printed skin as it allows us to get a better comparison to human skin. The skin is treated in such a manner that it will become as close to human skin as possible. This can be from the temperature of the skin to the oiliness of the skin and even the thickness of the skin depending on which body part.Or a punch biopsy is performed to extract skin from a volunteer. The main purpose of this study is to determine the effect the product will have on skin before it is applied directly on people. This may range from minor irritation to major rashes. All of which will be documented and placed in different levels of severity. Once this step has been completed, then and only then does the product move onto the next study.

In Vivo Study

Ex Vivo studies are usually performed after In Vitro on products that will be applied topically to the skin. During Ex Vivo, the product is applied directly to living skin. A selected group of volunteers will be determined as the test group. Within the test group each volunteer will be given either the product or a placebo at random. A placebo is the control. This is done as to verify that it is the treatment which causes a positive change in the subject’s skin and not a random effect of the environment.

Once given the product, the volunteers are placed under observation for a maximum of 24 hours. Within this time they will record the effects the experience and the time at which they occur. This stage is extremely important as it confirms that the product does work as it should on people and that it can work on people with different skin types. No human’s skin is 100% the same as another. Hence the need to determine whether the product will work on multiple people with different skin types.

The above studies are essential to the development of new products for the cosmetic and skin treatment industry. Each one is meant to determine the main factor in the product or active that may potentially harm people, starting with most cost effective method first. Performing the study in tubes it far cheaper to determine a problem due to a change in temperature rather than jumping to the final stage and discovering the problem.