What is a clinical trial?
The medical profession advances through clinical trials. Clinical trials test whether new drugs, new medical devices, or new ways of using established drugs or medical devices are safe and effective.
Integrated Aesthetics follows strict rules to protect the subjects that participate in clinical trials. The goal, always, is to obtain reliable data from informed and willing subjects in order to advance the science behind medical applications in the field of aesthetics.
Are there clinical trials for aesthetic drugs?
Yes, this is a very active area of research, both for the face and the body.
- Botox is effective for forehead lines and crow’s feet
Examples of recent clinical trials that have resulted in new indications for existing drugs include:
- Restylane Lyft can be laid down in the midface with cannula
- Restylane Silk can be placed in the lips using cannula
Examples of new drugs that have been approved after being tested in clinical trials include:
- Jeuveau was approved for glabellar lines
- Restylane Refyne and Restylane Defyne were approved for the treatment of nasolabial folds
- Juvederm Volbella was approved for lips
Who can participate in aesthetic clinical trials?
Aesthetic clinical trials typically seek healthy men and women between the ages of 21 and 65 years old. Female subjects of child-bearing potential must not intend to conceive during the length of the trial and willing to be on birth control. In addition, subjects typically cannot have had a recent history of previous aesthetic treatments on the part of the face or body that is being evaluated in the study. Each trial has a lengthy set of inclusion criteria, which define the study’s target population, and exclusion criteria. These criteria are reviewed during the screening process.
What are the benefits of participating in clinical trials?
Some clinical trials test new drugs or technology, and qualified subjects can participate in treatments that are not available in the commercial market. Subjects that enjoy being on the front wave of innovation may prefer such trials. Other trials test minor variations on established products. These subjects perceive value in receiving treatments with established products.
What are the restrictions?
If you elect to participate in an aesthetic clinical trial, it means that you agree to receive the specific treatment that is being tested. The physician-investigator is not allowed to vary the treatment based on your individual preferences. In addition, you will be asked not to pursue other treatments that could affect the quality of the data. For example, if the study involves filler to a specific area, you will not be allowed to have other filler treatments in that area during the course of the study.
What is the time commitment?
In a clinical trial, the researcher typically follows the subject very closely. This requires multiple study visits over the course of the trial, which may last from six to twelve months or longer. These study visits may last from fifteen minutes to more than an hour. The study-visit schedule has some flexibility, but not unlimited flexibility. You may have some homework, such as keeping a diary.
Is there any cost to participate?
There is no fee to participate in aesthetic clinical trials. There is the cost of your time, however. Many studies will offer a stipend for your time.
How can I find out about aesthetic clinical trials at Integrated Aesthetics?
Visit our website to find out about current studies. Email firstname.lastname@example.org or phone Ismael at (832) 932-7892 with your contact information.