The Rising Cost of Cosmetic Procedures and the Appeal of Clinical Trials
As the costs of everyday items like gas and milk continue to climb, so too does the price of cosmetic procedures. With the expense of aesthetic treatments increasing annually, the allure of free fillers or complimentary skincare becomes more tempting. One of the most effective ways to access desired treatments without a hefty price tag? Participating in a clinical trial.
While clinical trials may appear to be a perfect win-win scenario—committing to regular appointments over several weeks or months in exchange for a free procedure or product that could otherwise cost thousands of dollars—they are not always as straightforward as they seem. To participate in these trials, you must meet a lengthy list of eligibility criteria, weigh the various pros and cons, and potentially relinquish certain rights. Here’s what you should know if you’re considering getting involved, whether it’s for a new product, device, or even cosmetic surgery.
Understanding Clinical Trials
Any new drug, device, procedure, or other product developed by a pharmaceutical company must undergo thorough testing to ensure its safety and efficacy. These medical studies, which explore both new and enhanced versions of existing therapies and involve human participants, typically go through several phases. Companies often rely on centers of excellence—often academic centers as well as real-world medical practices—to conduct clinical trials and appoint a physician as the principal investigator to oversee the entire study.
For Dr. Macrene Alexiades, a board-certified dermatologist in New York City who has been the principal investigator in over 75 clinical trials, this role comes with significant responsibilities. "I assist with protocol development, submission to IRB (institutional review boards), overseeing the trial, administering the treatments, writing manuscripts for publication, and presenting at meetings," she states. "I will participate as an investigator only if I have the time in my research schedule and can dedicate the necessary time and attention to the clinic."
Before a clinical trial can commence, it must undergo a review by FDA officials and IRBs to ensure the ethical treatment of human subjects. The company must submit its protocol, study goals, inclusion and exclusion requirements, and measurement forms for review from a safety perspective and to confirm that the benefits outweigh the risks. IRBs must approve the studies before they can start and also monitor the progress afterwards. The actual trials usually begin with some toxicology work, which may include animal testing, and then proceed to Phase I, which determines how the compound is absorbed, metabolized, and processed by the body and what the optimal dosage is. This phase involves a smaller group of patients and exposes them to the drug or product for a short period, providing each with a different dosage level. Although there might be indications of effectiveness at this stage, determining this is not the primary goal. Assuming no major safety concerns arise in Phase I, the trial progresses to Phase II, where the safety is tested among a larger number of patients over an extended period, ranging from several months to two years.
"Ultimately, it's your Phase III randomized control studies that truly matter," explains Diane Nelson, who has served as the director of medical affairs at both Anacor Pharmaceuticals and Medicis Pharmaceuticals and currently oversees medical, clinical, and scientific affairs at SkinBetter Science. "What this means is that you have a placebo—or, in dermatology, a vehicle—that helps you compare the active versus the vehicle of a topical product that doesn't have the active. You aim to show differences in improvement and safety between the active drug and nothing." Phase III involves the largest group of patients and can last for a few years. For this reason, the third and final phase is also the most crucial in ensuring that the agent lives up to its claims and is effective even in a much larger population. The data obtained here is then sent to a statistician and compiled into a report, which is submitted to the FDA as part of a new drug application (NDA). Even after the product has been approved, additional studies are frequently conducted to observe how it performs under "real-world" conditions. It should also be noted that clinical trials often assess patient satisfaction as well.
Products and Devices Tested in Clinical Trials
Anything that requires FDA approval, such as vaccines, prescription drugs (oral and topical), and medical devices, is legally obligated to undergo clinical testing in multiple phases; on the other hand, over-the-counter and cosmeceutical products do not have this requirement. "Whenever you pick up a product from the shelf, you hope that the company is ethical and not providing any misleading information," says Nelson. "But in reality, many companies don't really have anything to support their claims." This is where clinical trials, even though not mandatory in the OTC and cosmeceutical domain, can play a role. "At SkinBetter, we don't have to conduct studies, but we want to back up our statements," Nelson explains. "We say that we know a product improves the appearance of redness in the skin, and we actually know this because we studied it for 12 weeks, measured it at different times, and took photos. We want to be able to provide evidence based on the claims we make." [Editor’s note: the writer, Gabby Shacknai, is the daughter of SkinBetter’s executive chairman.]
Of course, in the non-FDA-regulated area, there is less supervision and no official committee to review the clinical research data. Therefore, it is essential for potential trial participants and consumers to look for IRB-approved studies, reputable principal investigators, and for the institution managing the study to have a good reputation.
Duration of Clinical Trials
Unfortunately, there is no fixed timeline that applies to all clinical trials. Depending on the product being tested, the therapeutic area under study, and the participating population, these trials can last from a few months to over a decade. "When you consider all those phases from a pharmaceutical perspective, it can take years to complete them all," says Nelson. "The overall duration really depends on the therapeutic area you are studying, but it can take a very, very long time." Especially when the active being tested requires FDA approval, where manufacturers must submit their findings to the federal agency after each phase and obtain approval before moving to the next, it is difficult to predict the trial's duration. However, since each trial phase typically involves a different group of patient participants, the time commitment as a participant is only a fraction of the total trial duration.
Requirements for Clinical Trial Participants
In every clinical trial, when recruiting participants, there is a set of inclusion and exclusion criteria, usually defined by the principal investigator and varying depending on the therapeutic area and the active substance. This typically means that to participate, patients must fall within a specific age group or race or have a particular health issue. In addition to meeting these enrollment requirements, participants must give up their existing medications, skincare treatments, or products so that investigators can accurately observe the effects of the active being tested. In dermatology, for instance, participants must stop using any other skincare products. "Sometimes, this requires a washout period. For example, if I'm studying a retinoid product but a participant has been using another retinoid product, I need to clear it from their system as best I can," explains Nelson. "We would require that you stop using that [product] for a certain period before starting the study because we want everyone to start on an equal footing."
Clinical trial participants must also sign an informed consent form (ICF), which indicates that the physician's nurse coordinator and/or research coordinator will go through all the requirements and potential risks of the clinical study. At the bottom of the ICF, there is a statement that they can withdraw from the study at any time, which, although it may pose a challenge for the trial, is necessary to ensure the patient's safety. Here, "they must also agree to the use of the data and their photographs," adds Dr. Alexiades. On top of all this, patients are asked to commit a certain amount of time to the trial and must adhere to a strict follow-up schedule, which can extend for months or even years.
Plastic Surgery Clinical Trials
Yes, although those for topical products, new treatments, and devices are arguably more common. Many plastic surgery clinical trials focus on implants, which the FDA considers to be medical devices. For this reason, they are often conducted for breast reconstruction or breast implants. Plastic surgery research also includes clinical studies on medications that can assist with aspects such as wound healing or pain after surgery. Keep in mind that there are similar, if not more strict, eligibility criteria for plastic surgery trials. It is also important to fully understand all the risks and potential side effects associated with the specific surgery, as is the case for any type of clinical trial or research study. To this end, it is a good idea to consult your healthcare provider before signing up for one.
Free Treatments in Clinical Trials
One of the obvious benefits of joining a clinical trial is receiving your treatment for free. "Almost always, there is no charge for the patient," says Dr. Roy Geronemus, a New York City dermatologic surgeon who has served as the principal investigator in more than 100 trials. "And many times, the patient may even receive compensation." However, it should be noted that free cosmetic surgery trials for plastic and reconstructive surgery might not always be completely free. For instance, you may not have to pay for the breast implant itself, but you might still have to cover the surgeon and anesthesiologist fees.
Signing Up for a Clinical Trial
There are several websites that list early-stage clinical trials, so checking one of these is always a good option. The U.S. National Library of Medicine maintains a database of privately and publicly funded clinical trials worldwide, where you can search by condition/disease or location, and CenterWatch is an excellent resource for clinical trial information, both for patients and medical professionals. (You can also search based on different specialties, including not only dermatology and plastic surgery but also oncology, pediatrics, and more.) ClinicalTrials.com, ClinicalTrials.gov, and ClinicalConnection also list a large number of trials, and the World Health Organization provides an easy and accessible registry where patients and doctors can find each other. Additionally, the websites of individual medical practices often display all the trials they are involved in. Finally, as Dr. Alexiades suggests, "patients can contact the site where the research is being conducted and ask if they can be interviewed for a slot," but she warns that individual centers have their own guidelines for accepting subjects for screening.
