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• 6 Effective Strategies to Boost Patient Recruitment in Dermatology and Rheumatology Trials

We are thrilled to have Nadine Clervoix, Clinical Research Coordinator at Innovaderm, with an impressive 25 years of experience in the clinical research environment. In this episode, we discuss the effect of seasonality on dermatology clinical trial patients. Our conversation will cover 4 main points:  

1. Effects on skin 
2. Lifestyle restrictions  
3. Study design  
4. Patient retention  

Effects of Seasonality on the Skin  

Skin prefers moderate temperatures and thrives on consistency. Seasonal temperature shifts can disrupt the skin barrier. Transitioning from hot to cold weather introduces drier conditions and exposure to indoor heating, reducing moisture in the air. This lack of hydration can lead to various dermatological issues, including inflammation, dryness, and clogged pores due to excess skin or sebum production. Conversely, moving from cold to hot weather has 2 main impacts: increased sweating and exposure to UV radiation. UV radiation can improve skin conditions, and several inflammatory diseases tend to improve in warmer weather.  

Influence of the Sun on Psoriasis 

The main impact of sun exposure on psoriasis is UV radiation. Approximately 80% of patients who expose themselves to the sun report improvement in their psoriasis. However, about 50% of psoriasis patients experience a season-independent disease. Within this group, some patients do better in the summer, while others improve in the winter. A few patients experience marked worsening during warm periods. Psoriasis is a chronic, inflammatory autoimmune condition of the skin, associated with genetic predisposition, health status, and numerous environmental factors such as smoking, alcohol, drugs, diet, infections, and stress, all of which can aggravate the condition. Therefore, the seasonal influence on psoriasis is likely orchestrated by multiple factors.  

Patients Show Improvement in Summer and Deterioration in Winter 

In the winter, decreased humidity and lack of UV radiation from the sun contribute to deterioration. Approximately 80% of patients improve significantly during the summer due to increased humidity and UV exposure from the sun. However, others worsen, often due to increased inflammation induced by sweating.   

Influence on Recruitment  

The patient database reflects seasonal variation. Participants meeting inclusion criteria for disease extent and severity on a given screening day may no longer quality for randomization a few weeks later. Interest in trial participation tends to wane in the summer and increase in the winter, correlating with the severity of many dermatological conditions and the weather. Patients seek solutions and options, as symptoms are generally more severe in cold, dry seasons. Seasonal changes can affect patient symptoms, treatment efficacy, regimens, participation rates in clinical trials, and even the validity of trial results.  

Lifestyle Restrictions 

Dermatology protocols often include lifestyle restrictions that must be adhered to, such as no excessive sun exposure, which is frequently listed in the exclusion criteria. For topical investigational products, protocols often prohibit swimming for several hours after application. Strenuous exercise is also often restricted for 2 reasons: safety lab tests, such as Creatine Kinase tests, must be performed, and excessive sweating can affect the absorption of topical investigational products. Many protocols require regular daily application of the investigational product, which can impact recruitment. Additionally, alopecia protocols often include a no-shaving requirement, further affecting recruitment. 

Impact of Study Designs on Recruitment 

The nature of the drug, the disease, and the trial requirements can significantly impact patient motivation. Flexibility in travel, such as spending 6 months a year in Florida for example, makes drugs that are easy to self-administer more preferable. Studies requiring intense pharmacokinetic-pharmacodynamic sampling are more challenging to enroll and may see better recruitment during holidays when work and school schedules are on pause. Traditional trials necessitate patient visits to the investigative site for all physician interactions. However, decentralized trials now leverage digital tools and technologies to enable remote completion of tasks that typically require face-to-face interactions, without compromising efficiency. This approach is great for phase 4 studies, quality of life studies, and studies focusing on symptoms such as pruritus. Unfortunately, this model is not suitable for typical atopic dermatitis and psoriasis trials at Innovaderm, as evaluating disease severity remotely is challenging for doctors and obtaining U.S. Food and Drug Administration approval for visual efficacy assessments via telemedicine is difficult.  

Effects of Seasonality on Retention 

Retention in dermatological clinical trials is challenging, with long journeys and frequent visits being common reasons for premature dropout. Utilizing the flexibility of visit windows allowed by the protocol and extending visit hours can help mitigate this issue.  

As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time. 

Let’s shape the future of research and make a difference in the industry, gain Innovaderm’s support in your upcoming trial and propel your study to new heights.   

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