Advancements in skin care don’t happen by accident. Oftentimes, it takes dedicated time, care, and intentionality to solve both common and rare skincare concerns.
That’s why here at Apex Skin, we have a dedicated clinical research team to learn as much as they can about skin conditions and formulate treatments that are tested, and work!
Here to help you learn a little more about what clinical research is and even how you can help further the advancement of skincare is Theresa Hanslick.
What is Clinical Research?
All pharmaceutical medicines require a lengthy process of review before being approved by the FDA (U.S. Food and Drug Administration) for human use. This process can take many years as studies progress through the “phases”. As opposed to “pre-clinical,” the research is considered “clinical” once humans are included.
Why did Apex decide to start a Clinical Research Center?
“Apex Skin and Surgery Center’s primary focus is to Transform Lives through Healthy Skin. The practice offers care for all dermatological needs, including skin cancer and rare skin disorders. Adding a research division to Apex allows another excellent option for both the patient and provider.”
Dr. Jorge Garcia-Zuazaga, founder of Apex Skin, wanted to offer our patients cutting edge opportunities to participate in developing new therapies for the very disorders we treat. It’s an exciting time to be helping pharmaceutical companies bring new drugs for dermatology to market!
Patients participating in clinical trials receive all care and study medicine at no cost to them or their insurance. The patient participant is followed by our own doctors and specially trained research professionals at Apex. Our providers also have the option to offer a research trial to their patients, especially when other medicines aren’t helping or stop working.
Who is on the Clinical Research team at Apex?
We continue to grow our Research Team with Dr. Garcia-Zuazaga, who also acts as the Lead Investigator for most of our studies. Theresa Hanslik manages the operations, while Caroline Matyas leads the program “on the ground”. Several new members have recently joined our team, as well and we are still growing!
Where is the Apex Clinical Research Center?
“Our research center is inside our new, state-of-the art, medical building in Mayfield Heights, OH. We will have approximately 2,000 square feet of space dedicated to research.”
What are some of the completed studies that Apex has done?
Apex Clinical Research has recently completed several global studies, including trials in atopic dermatitis, and psoriasis. We also contribute to “late stage” or “real life” study data by enrolling interested patients in studies where the drug is already on the market. These are sometimes called registry studies or “standard of care studies”.
“We are currently enrolling patients in studies on psoriasis, atopic derm, vitiligo, neurofibromas. In addition, we have also completed a handful of studies in the field of cutaneous oncology, for skin cancers and precancers.”
What did the patients experience as a part of those studies?
Clinical trials are based on patient safety. All our patients participating in a study will be carefully monitored by our experienced research team. Usually, these visits include surveys, clinical exams, some labs, and a physician assessment.
Most studies reimburse patients for travel and have a stipend for participating. Visits are usually once a month for the duration of the study. The patient is also in total control—they can withdraw from the study at any time.
How do we partner with the research sponsors?
Research sponsors need qualified physicians, as well as strong research teams to conduct their study protocols. The pharmaceutical sponsors also want to be assured that the physician’s “research site” has patients to enroll. Remember, without patients, we don’t have “clinical research”.
Dr. Garcia is both qualified and has a large network of providers to help spread the word to patients. Our research site exemplifies “excellent work” hence we are soon becoming the go-to for many large, sponsored studies.
Partnering with a sponsor requires an agreement and a promise to perform good work. Quality comes first!
What studies are underway now?
“We are currently enrolling new patients in studies for plaque psoriasis, atopic dermatitis (eczema) for adults and children, vitiligo, and lichens planus. Some upcoming studies include rare conditions, such as ulcerative pyoderma gangrenosum.”
What is your favorite part of Clinical Research?
“I love seeing the patients receive excellent care and attention. This includes open communication and a chance to become better educated on their skin disorder. Many times we find ourselves “coaching” the patient on other issues, such as diabetes or hypertension.
Surveys indicate that patients feel supported, yet not pressured. Most patients report a very positive experience and ask when they can participate in the next study!”
What studies are you hoping to work on in the future?
Many dermatological conditions are linked to autoimmune disorders. For that reason, many indications overlap, such as psoriasis and psoriatic arthritis or lupus. We’d like to collaborate across other disciplines, such as rheumatology, so we can include some of those patients in our studies.
How can patients sign up to participate?
Patients may learn about the studies through their Apex Skin provider. However, at times, patients may see our flyers or social media stories. Potential patients can simply email us at research@apexskin.com or call us at 440-867-1503 (Caroline) or 440-477-1570 (Theresa)
