Dr. Michelle Chambers, a Remington-Davis (RDI) board certified dermatologist, has been involved in dermatological clinical research since the 1990s — she brought her expertise to Remington-Davis in 2019. We recently had the chance to sit down with Dr. Chambers and look at some developments and challenges related to clinical research in dermatology.
The Rise of Immunotherapies to Treat Dermatological Diseases
In recent years, researchers have found that numerous skin conditions have an immunological basis. While vitiligo can be caused by stress, genetics or trauma, studies also show that people with this dermatological condition can have melanocytes, which spontaneously activate the immune system under stress, that are more sensitive to external factors. If these signals are sent out too often or incorrectly, the immune system can become overwhelmed and destroy melanocytes, causing the depigmentation related to vitiligo. (Note that vitiligo can also be seen in conjunction with other autoimmune conditions like pernicious anemia and thyroid disease, which further impact immune system response.)
To this end, immunomodulators have become a common thread in dermatology clinical trials. JAK inhibitors and monoclonal antibodies have emerged as treatment options, ushering in a new class of medications to help control chronic skin diseases. In the case of atopic dermatitis, JAK inhibitors have shown promise in closing off overactive JAK pathways and limiting cytokines that can trigger eczema symptoms.
The rise in immunomodulators is one of the most exciting advancements in dermatology clinical research, bringing newfound relief to sufferers of chronic conditions. However, with the use of these drugs, physicians have to think about how they put patients at risk for other infections. It becomes a dynamic of weighing their potential risks versus their benefits to the patient.
Monitoring the Impact of These Immunotherapies During Trials
Photography has long been a critical component of dermatology clinical trials, allowing for the visual tracking of improvement and change. The majority of calculations related to these visualizations are performed by hand or eye, as there’s no current technology that can perform the calculations for physicians.
To perform objective comparisons, standardization is key. Physicians need to be able to standardize the distance at which they take photos, use the same exposure every time and make sure the lighting is consistent. Technology can support standardization efforts by allowing physicians to feed photos into a computer to assess any improvements that aren’t visible to the naked eye.
While clinical research in dermatology remains relatively low-tech, there are some talks around imaging and calculation advancements, specifically in the vitiligo pipeline. Still in its early stages, 3D imaging has shown promise for full-body analysis of vitiligo lesions.
Patient Enrollment Challenges for Dermatologic Conditions
Before there were biologics available to treat psoriasis, getting individuals to enroll in clinical trials related to this condition was relatively easy. Now, with treatment options available, patient enrollment has become more challenging. Without having to sign up for a trial, people with insurance coverage can get access to the treatment they need.
For a lot of dermatology clinical trials, people are motivated by the fact that conditions are visual in nature. When skin is flaking off or there are noticeable spots, individuals want to find relief as fast as possible. If there’s already a drug available for treatment, they’d rather have access to that than enrolling in a trial where there’s a placebo effect.
What also makes trial enrollment challenging is that patients typically need to have a certain amount of a dermatological disease to enroll in a trial. The threshold for study enrollment is much higher than a patient’s tolerance threshold, which can be based on discomfort as with atopic dermatitis or visible changes related to skin disease, as with vitiligo or alopecia.
With alopecia, for instance, most trials require 50% hair loss. The reality is that people with much less than 50% hair loss will be bothered by the condition. This rules out a lot of individuals that can not only enter the trial but are motivated to stay enrolled throughout the duration of the clinical trial.
Thank you to Dr. Chambers for her insights into the evolving dynamics of dermatology clinical trials and the challenges surrounding patient enrollment. While using our extensive patient database and dynamic campaigns to recruit patients in a timely fashion, we prioritize patient-centric service to help keep enrolled participants engaged.
Contact us today to see how we can support your next clinical trial.