Advancing Representation in Dermatology Clinical Trials: Ethical, Scientific, and Regulatory Imperatives for Inclusion Across all Fitzpatrick Skin Types

Underrepresentation of darker Fitzpatrick skin types in dermatology clinical trials remains a persistent scientific and ethical problem in the United States. Although the U.S. population has become markedly more diverse, clinical evidence in dermatology continues to be generated using samples disproportionately composed of individuals with lighter skin types. This imbalance raises concerns regarding diagnostic accuracy, therapeutic efficacy, and safety assessment across the full spectrum of skin phenotypes. The recent growth of the field of skin of color dermatology has highlighted the limitations of dermatologic knowledge derived primarily from light-skinned participants and has prompted renewed attention to inclusive research design. In this paper, we examine why certain Fitzpatrick skin types are systematically prioritized in dermatology trials, describe the scientific and clinical consequences of this imbalance, and evaluate how diversity oriented methodological practices, regulatory expectations, and specialty level developments can strengthen both the internal and external validity of dermatology research. Drawing from bioethics and regulatory perspectives as well as clinical dermatology expertise, we propose an updated framework for improving representation, advancing patient equity, and ensuring that dermatology research more accurately reflects the population it intends to serve.