Recruiting patients for dermatology clinical trials presents unique challenges, particularly due to the influence of seasonal changes. These fluctuations can significantly impact various aspects of the recruitment process, from the condition of the patientâs skin to their daily routines and lifestyle choices. Understanding these dynamics is crucial for designing effective studies and maintaining patient retention. This article will explore 4 main points: the effects of seasonal changes on skin, the lifestyle restrictions imposed by different seasons, the implications of study design, and strategies for ensuring patient retention. By examining these factors, we aim to provide a comprehensive overview of how seasonality affects dermatology patient recruitment and offer insights into optimizing this critical phase of clinical trials.
Effects of Seasonality on the Skin Â
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 PsoriasisÂ
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 WinterÂ
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 Â
The patient database reflects seasonal variation. Participants meeting inclusion criteria for disease extent and severity on a given screening day may no longer qualify 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 RestrictionsÂ
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 (IP), 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 (CK) tests, must be performed, and excessive sweating can affect the absorption of topical IP. Many protocols require regular daily application of the IP, which can impact recruitment. Additionally, alopecia protocols often include a no-shaving requirement, further affecting recruitment.
Impact of Study Designs on RecruitmentÂ
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 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 phaseâŻ4 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 Indero, 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.
Given the previously discussed impact of seasonal changes on recruitment, prioritizing patient retention becomes essential. Retention in dermatology clinical trials is often challenging due to factors such as long commutes and frequent visits, which can lead to premature dropout. Seasonal changes can exacerbate these issues, making it even more crucial to implement strategies that enhance patient retention. Utilizing the flexibility of visit windows allowed by the protocol and extending visit hours are effective measures to accommodate patientsâ schedules and reduce the burden of participation. By addressing these challenges, clinical trials can improve retention rates and ensure the collection of high-quality data throughout the study.
Letâs shape the future of research and make a difference in the industry, gain Inderoâs support in your upcoming trial and propel your study to new heights.
About the AuthorÂ
Nadine Clervoix, RN, MT, CCRP, CCRC
Nadine Clervoix is a Clinical Research Coordinator at Innovaderm Research, Inderoâs Clinical Research Unit (CRU), bringing an impressive 25-year career in the clinical research environment, Nadine has developed a deep expertise in dermatology clinical trials. Her extensive knowledge and skills have significantly advanced research and patient care within the Innovaderm CRU. Nadineâs dedication to clinical research and her commitment to improving patient outcomes make her an invaluable member of the Innovaderm team.
