Clinical trials play a crucial role in advancing medical knowledge and developing new treatments. However, when it comes to dermatology, there is a significant underrepresentation of patients with darker skin types and skin of color. This exclusion from clinical trial participation, including cosmetic and aesthetic dermatology, stems from various factors, including the historical bias rooted in the Fitzpatrick skin type classification system. Let's explore the reasons behind this disparity and the importance of embracing inclusivity in dermatological research.

The Fitzpatrick skin type classification system, developed in the 1970s, categorizes individuals into six skin types based on their response to sun exposure and their propensity to tan or burn. While this classification has been widely adopted in dermatology, it fails to account for the rich diversity in skin types and tones present in different populations worldwide. This limited approach has inadvertently led to the exclusion of patients with darker skin types from clinical trials, where representation should reflect the actual patient population seeking treatment.

One of the primary reasons for the underrepresentation of patients with darker skin types in clinical trials is the belief that their skin is less prone to certain dermatological conditions. Historically, research and clinical trials have predominantly focused on conditions more commonly observed in individuals with lighter skin, such as acne, rosacea, and photoaging. This bias has perpetuated the notion that dermatological concerns are less prevalent or less severe in patients with darker skin, which is far from the truth.

Another contributing factor to the lack of diversity in clinical trial participation is the misconception that certain treatments may not be as effective or safe for individuals with darker skin. This assumption arises from limited research and data specific to patients with skin of color. Consequently, dermatologists may hesitate to enroll patients with darker skin types in clinical trials, fearing potential adverse reactions or inadequate treatment outcomes.

The consequences of excluding patients with darker skin types and skin of color from clinical trials are far-reaching. It perpetuates the knowledge gap regarding the unique dermatological needs and responses to treatment in diverse populations. It also limits the development of evidence-based guidelines and tailored treatment approaches for patients with skin of color. Moreover, it hinders the ability to assess potential side effects, efficacy, and safety of treatments across all skin types.

Recognizing the importance of inclusivity, efforts are underway to address this disparity in dermatological research. There is a growing call for greater diversity in clinical trial recruitment, with initiatives aimed at increasing representation of patients with darker skin types. This includes raising awareness among researchers, dermatologists, and the general public about the need for diverse participation and the significance of tailored treatments for different skin types and tones.

Additionally, regulatory bodies and research organizations are advocating for improved guidelines and protocols to ensure appropriate representation in clinical trials. Efforts are being made to encourage researchers to actively recruit individuals with diverse skin types, develop standardized assessment tools for dermatological conditions in different populations, and promote collaborations to enhance inclusivity in dermatological research.

It is crucial to emphasize that dermatological concerns affect individuals of all skin types and colors. By embracing inclusivity and actively including patients with darker skin types and skin of color in clinical trials, we can improve the understanding of dermatological conditions across diverse populations, ensure equitable access to effective treatments, and provide evidence-based care for all patients.

The exclusion of patients with darker skin types and skin of color from clinical trial participation in dermatology is a long-standing issue rooted in historical biases and limited understanding. Addressing this disparity requires a commitment to inclusivity, increased awareness, and concerted efforts to promote diversity in research. By embracing a more comprehensive and representative approach, we can bridge the knowledge gap, develop tailored treatments, and advance dermatological care for all individuals, regardless of their skin type or color.

By Alexander Brosda, CEO Sokörpe Laboratories