Clinical trials in general are medical research studies designed to evaluate the safety and effectiveness of a new product or treatment in addressing specific conditions. Skin care clinical trials specifically are done to study the effectiveness and safety of new products or formulations to treat certain skin conditions. These trials are usually pharmaceutical, cosmeceuticals, device or supplemental. Skin care clinical trials may also be done to study the short term effects and the long-term effects of a product that has already been approved.
What’s Involved in Developing a New Product?
Developing a new product or treatment can take years of developing and research. The developers then perform a series of tests/studies. The researchers need to test how well the drug works on human subjects and sometimes non-human subjects. They, therefore, hold clinical trials to determine how safe and effective the new product is before it can be brought to the market. During the trials, the researchers collect data about the product and its effects. Human research is overseen by a regulatory agency called the IRB, which protects the rights of human subjects. In America, the final data is then passed on to a government regulating agency like the Food and Drug Administration (FDA) for final approval of the drug. Once approved, the products’ developers can begin marketing it to the public.
What are the Different Phases of Research Development?
Phases are the different stages the drug/product/device has to go through to get the product to the market. The FDA describes five phases that are distinguished by their purposes:
• Phase 0 describes exploratory studies that may or may not involve human volunteers.
• Phase 1 describes studies that evaluate the safety of a drug and its worst side effects. The researchers use healthy volunteers at this point.
• Phase 2 starts evaluating the drug’s effectiveness and any short-term side effects. Participants are often divided into two groups: one group gets the drug, while the other is given a placebo.
• Phase 3 continues evaluating the drug and studies such matters as possible drug interactions, the effects of different doses and the drug’s effects on different populations.
• Phase 4 studies take place after the drug has been approved.
Additional Considerations About Skin Care Clinical Trials
The first part of a clinical trial is typically the screening process. Research subjects will need to qualify for the clinical trial by inclusion/exclusion criteria. They may want participants of a certain age range, for example.
If the applicant is deemed eligible to participate, the researcher will provide a detailed explanation of what will happen during the trial. Such explanations are required by federal law, and are called informed consent.
At DeNova Research in Chicago, we are committed to conducting accurate and reliable research studies, including skin care clinical trials. We have researched everything from fillers, radiofrequency devices, facial implants and cosmeceuticals. Contact us today to learn more about how we can help you!