Vero Beach plastic surgeon by Dr. Alan Durkin, MD, has put our seaside town on the scientific map by conducting a randomized, double-blind study of a medical product known generically as derma filler.
The results of the study, which was done in collaboration with Florida State University Medical School, were published last month in the Journal of Cosmetic Dermatology, a peer-reviewed scientific journal.
The $250,000 study compared the longevity and patient satisfaction of two derma filler products: calcium hydroxylapatite (CaHA), marketed as Radiesse; and hyaluronic acid filler (VYC-20L), marketed as Juvederm Voluma.
Dr. Durkin says it was the first randomized clinical trial ever designed, created, funded and executed on the Treasure Coast.
“I don’t think that people realize that we have everything we need here in Vero Beach to conduct a nationally qualified study,” said Dr. Durkin. “We administered the products at our med spa and worked directly with students at FSU to coordinate the data and get institutional review approval. There are a ton of moving parts involved in a study of this nature and we relied heavily on the expertise of the students at FSU to assist us every step of the way.”
Dr. Durkin, who is vice chairman of surgery at Cleveland Clinic Indian River Hospital and serves as a clinical assistant professor at Florida State, set out to define which derma filler delivered the most desirable result and which was the most cost effective.
“Fillers react in different ways,” Dr. Durkin explained. “The way that we stratify how fillers respond is called rheology, or the study of elasticity verses viscosity verses cohesivity.
Consider a piece of toasted bread. If I put drawn butter on it, it soaks in the holes and the bread absorbs it. But if I put peanut butter on it, it stays on the top. That means that the peanut butter has a higher rheology than butter. The term we use for that is G-prime, and the higher the G-prime, the higher the cohesivity.”
“After I inject something with more cohesivity into the human face I tend to get more of a lift effect than just a fill effect,” said Dr. Durkin, who has authored more than 30 peer-reviewed scientific papers, according to his LinkedIn page. “That’s a big deal in the aesthetic world because most patients don’t want a balloon look, they want a lifting effect. We wanted a study that compared products and scientifically recorded their results.”
To initiate the study, Dr. Durkin contacted the manufactures of both products to see if they were interested in having a randomized clinical trial. The manufacturer of Radiasse immediately agreed and volunteered to fund the cost of products with a $250,000 grant, while the manufacturer of Voluma did not respond. The study was intended to have 20 subjects for each product, but through attrition only 17 subjects saw it through all the check points.
“First we had to find the volunteers who agreed to their results measured,” Dr. Durkin said. “The patient didn’t know which product they got injected with and we took high-definition photos at different set points. We sent photos to the patients on day 1, 7, 30, 90, 180 and 365, and asked them to rate the change. I also sent all the photos at the different intervals to an out-of-state colleague and asked him to rate the changes. He was a completely blinded plastic surgeon and he rated them according to the GAIS (Global Aesthetic Improvement Score). I was only partially blinded as I had to know which product I was injecting just before the injection as they are injected differently.”
The doctors at the med spa sent all the data to the college, where they created a spreadsheet of the results. The blinded plastic surgeon created his own spread sheet and sent it back to the college. After interpreting all the data, Dr. Durkin along with his colleagues, certified physician assistants Maxwell Poling and Nick Woltjen, wrote a paper based on their findings. It was reviewed by four blinded board-certified dermatologists/plastic surgeons and then submitted to the Journal of Cosmetic Dermatology, a peer-reviewed scientific platform for plastic surgeons and dermatologists. It was submitted in June 2020 and published last month.
“No one has ever done a study like this locally,” continued Dr. Durkin. “We had to show we had the infrastructure, write the prospectus, get HIPAA (Health Insurance Portability and Accountability Act) compliance for everyone involved and recruit, inject and track all the subjects.”
The physicians who reviewed the study felt both products performed very well, with no significant difference. The patients, however, noticed a difference, with Radiesse being rated higher. “With Radiesse the patients looked elevated and chiseled. Voluma made their cheeks look more like a chipmunk,” Dr. Durkin said. “There was a substantial difference in cost as well. Three ccs of Radiesse cost the patient $1,300, while the same dosage of Voluma cost $2,500.”
The results of this study indicated that Radiesse supports better, more durable outcomes than an equal volume of Voluma, and shed light on the fact that consumer advertising isn’t always based on science. Dr. Durkin said he will use Radiesse as derma filler in his practice moving forward.
“Now more than ever, consumers have to ask questions and stay informed about products. If the physician administering the facial filler doesn’t have the answers or only has one option, go to another practice,” said Dr. Durkin.
“I’m attempting to inform the public through science. This method now exists in Vero Beach and we are proud to put Vero on the map for plastic surgery and dermatology.”
Dr. Alan Durkin is a diplomate of the American Board of Plastic Surgery and American Board of Surgery. He is vice chairman of surgery at Cleveland Clinic Indian River Hospital and on staff at Sebastian River Medical Center. He specializes in cosmetic plastic surgery and reconstructive plastic surgery of the face and breast. He can be reached at Ocean Drive Plastic Surgery and Med Spa in Vero Beach, 772-234-3700.