Many people form opinions about people based on their outward appearances. What are they are wearing, are they neat or unkempt, smiling or sullen, thin or chubby, tall or short? Another thing that is noticed is their skin. Everyone would love to go through life with a flawless complexion and perfect skin, but for many, that is not the case. Some patients’ skin issues respond to drugs, creams, ointments or injections to keep it under control. Others may find their treatments become less effective over time and, for some, no current treatments have helped their situation at all. It is for these reasons that pharmaceutical companies spend years working on new formulas and products in the hope that relief can finally be found for those suffering. In order for a drug to make it to market, there are many, many steps that must occur. One of the most important ones is clinical trials. Wake Forest Baptist Health Dermatology has many new and ongoing clinical studies that might be right for you or someone you know who is dealing with a dermatological issue. Although most trials involve people in their teens or older, there have been some that include infants and children.
“I think a lot of people are unsure of what clinical research really is,” said Adele Clark, PA-C, director of Clinical Studies Center. “They hear the word ‘research’ and think ‘Guinea pig.’ Our research trials are very focused — we just do dermatology trials. Now, more than ever, the safety and privacy of people in these trials is really protected. Patients have to be notified of any risk that is in the study. We are not trying to ‘trick’ participants. In some trials they will know if they are using the actual study drug. In others, they know they could receive the study drug or a placebo (no active medication.)”
Once accepted, the participant has a schedule of visits they need to follow in order for the data to be tracked accurately. Trials can last a few weeks to several months, with a small number lasting for years. “There are a lot of new medicines that come on the market,” said Clark. “Those drugs are there because people around here and throughout the country were willing to be in a trial. Most people want to find help for their skin condition in a trial. Other participants do trials because they want to do something good for society and help other people with their skin condition. By doing the study, they hope to help new products become available to everyone.”
Not everyone with the skin disease treatment being researched will be accepted into the trial. The company sponsoring the study has very definite guidelines that must be adhered to. For example, a person with acne may need a certain number of lesions to be accepted in the trial. For those who do make it into the study, there are benefits that include becoming educated on their condition, getting financial compensation for their time and travel, and having a free physical exam. “We may do vital signs, blood work, chest x-rays, or heart tracings before starting someone in a trial,” said Clark. “There have been people that have had something show up on one of these tests that needed a follow-up, and they may not have known about that if they hadn’t come about one of the trials. One of the primary goals is to protect the safety of the participant.”
The mission of the Wake Forest Baptist Health Department of Dermatology Clinical Studies Center is “…to provide the highest quality research data to gain FDA approval for industry-leading medicines to improve medical care for patients with skin diseases.”
“We primarily conduct trials for eczema, psoriasis, itching, acne, rosacea and toenail fungus,” said Clark. “We do have some trials for lupus and auto-immune diseases, razor bumps and hair loss. It is important to note that there are new studies involving other diseases of the skin starting all the time.”
For more information on the trials being offered, upcoming studies and how to get involved, call 336.716.3775, e-mail firstname.lastname@example.org or check the website at www.wakehealth.edu – dermatology – clinical study. The Wake Forest Baptist Health Clinical Studies Center for Dermatology Research is located at 4618 Country Club Road in Winston-Salem.