Clinical trials are critical to shaping the future of healthcare and aesthetic medecine. But that doesn’t mean they’re your ticket to a free plastic surgery makeover. We spoke to four doctors about the risks and benefits of volunteering to test new cosmetic procedures.
What Is a Clinical Trial?
A clinical trial is a study in which researchers evaluate people who have agreed to undergo a new treatment under close supervision. The purpose of this research is to identify new treatments with an acceptable number of potential side effects. Clinical trials are critical to shaping the future of medical care.
There are different types of clinical trials, including risk reduction trials, diagnostic trials, trials relating to quality of life for those with chronic illnesses, and treatment trials. In the cosmetic surgery arena, clinical trials usually have to do with treatment.
Believe it or not, researchers are often desperate for people willing to take part in their studies, and this includes free plastic surgery trials. Without subjects, these research studies can’t take place. A surprising number of clinical trials fail to reach completion — or never get off the ground in the first place — due to a dearth of willing participants.
In other words, if you’re a good candidate for a particular clinical trial, you have a good chance of being accepted into it.
How Clinical Trials Work
Clinical trials seek to answer questions such as whether a potential treatment works, whether it is superior to other treatments, and whether or not it has side effects. A trial also may reveal how much a treatment costs, whether or not a diagnostic technology is worth pursuing, or how a potential treatment might affect patients’ quality of life.
Researchers follow a specific plan, or protocol, when conducting a clinical trial. This protocol outlines which patients are eligible for the trial, when and how often surgical procedures or tests will be performed, any drugs that will be used along with their dosages, the follow-up dates and scheduling, and the duration of the study.
Clinical trials are carried out in phases, with each phase designed to provide insight into a specific question the researchers have. The protocol details the endpoints (outcomes) to be measured and what sort of information will be collected. This information may be shared with regulatory authorities in order to receive authorization for marketing, and with insurance companies for the purpose of reimbursement.
Cosmetic Surgery Clinical Trials
According to Dr. Andrew Trussler, MD, a board certified plastic surgeon in Austin, Texas, the clinical trials that exist in cosmetic plastic surgery generally involve either a device or injectable materials.
“There are not many medication trials in this field, but anything that is placed on or in the body will undergo some element of trial to determine safety and efficacy,” says Trussler.
That includes implantable devices like breast implants, or injectables neuromodulators such as Botox or fillers like Restylane, which have all undergone trials.
“Laser devices and other cutaneous or subcutaneous energy technologies go through clinical trials as well,” adds Trussler. “Typically, plastic surgery procedures like facelifts are already proven safe and effective and are not common in trials, but devices used within a procedure — tissue glues, for instance — could be trialled in a facelift application.”
There are also reconstructive plastic surgery trials, which differ somewhat from cosmetic plastic surgery trials.
“Reconstructive clinical trials may also focus on a new technique or product/device, but are aimed to restore a part of the body due to trauma, accident, illness, or birth defects,” says Dr. Eric Wimmers, MD, a board certified plastic surgeon in New Jersey. “Reconstructive clinical trials will look for any potential side effects and outcomes based on the nature of the procedure. Some outcomes may include: decreased pain, reversal of disease, improvement of disease, and improvement in quality of life or the ability to complete daily tasks.”
Should I Participate in a Clinical Trial?
Not everyone is a candidate for every clinical trial, and clinical trials are no way to get a free plastic surgery makeover.
If you’re interested in participating in a particular trial, you will first need to find out if you are a good candidate. All clinical trials have guidelines about who can participate (inclusion criteria), as well as guidelines that prevent someone from participating (exclusion criteria).
As Trussler explains, “If a patient is not able to follow-up, has an allergy or pre-existing reaction, or any other difficulty with the treatments they should not enter. The trials are not for the individual person but to gather data on the device or product to delineate whether it is effective and safe for mass distribution.”
However, eligible candidates who choose to participate in clinical trials have the opportunity to contribute to their own medical care, not to mention access to potentially exciting new treatments before they are available to the general public. Participants usually receive outstanding care from the physicians involved in the study.
As Dr. David A. Schlessinger, MD, a board certified ophthalmologist in Woodbury, New York puts it, “[participants] get the opportunity to help advance the science of plastic surgery and may receive beneficial results without charge. In some cases candidates may even receive monetary reimbursement for their time.”
Trussler has similar sentiments about the clinical trials process. “I was an investigator in the Reloxin Trial — which is now called Dysport — and patients liked the free repetitive treatments for the 2.5 year trial,” he says.
What Are the Risks?
It’s important to understand that clinical trials have risks. For example, it’s possible that the treatment won’t have the intended effect. It could take longer than expected. Some patients experience serious (and in rare cases, life-threatening) side effects, and these effects may differ from those associated with treatments that are presently available.
As Dr. Flora Levin, MD, a board certified oculofacial plastic surgeon in Westport, Connecticut, points out, “you must be comfortable using a product or drug which is experimental.”
Trussler adds that candidates should also be amenable to repetitive treatments and the associated follow-ups, as well as accept the risks of any negative outcomes.
That being said, numerous safeguards exist to ensure participants are safe. Regulators require that researchers follow Good Clinical Practice (GCP), an international ethical and scientific quality standard for trials that involve the participation of human subjects. For example, all clinical trials for new treatments must go through several steps — also known as phases — before receiving approval from regulatory bodies.
Every clinical trial conducted in the United States, whether for a device or treatment, must receive approval from both the US Food and Drug Administration (FDA) and an institutional review board (IRB). These safeguards help to mitigate any potential risks while increasing the chances that the potential benefits will be worth it.
Should you decide that you’d like to move forward with a clinical trial, you will also be required to learn the key facts related to the trial. (This is called informed consent.) Research is always voluntary, however. As Wimmers points out, “Participants are able to withdraw at any time for any reason if they no longer wish to participate.”
You must be comfortable using a product or drug which is experimental.
Dr. Flora Levin
How to Find a Plastic Surgery Clinical Trial
A good online resource for clinical trials in the United States is ClinicalTrials.gov, a website operated by the U.S. National Institutes of Health. You could also try Clinical Trials GPS.
Trussler also recommends keeping your eye out in local newspapers and reaching out to local clinics or hospitals. “Commonly they are offered at research departments of teaching institutions and/or university medical centers,” he says. “Larger private practices and practitioners may be included into the studies if appropriate, which may be the case in cosmetic trials.”
And Levin adds that trials may be run by pharmaceutical or aesthetic companies through established medical practices that are known to participate in medical research. “Such practices may advertise to their patients when there is enrollment in a new clinical trial,” she says.
To learn more about plastic surgery clinical trials, or if you are interested in a free plastic surgery consultation, contact a local plastic surgeon today.