Blueprint For Mechanistic, Data‐Rich Early Phase Clinical Pharmacology Studies In Dermatology

By Robert Rissmann, Matthijs Moerland, and Martijn BA van Doorn

The landscape of dermatological drug development has transformed dramatically over the past two decades, with targeted therapies revolutionizing the management of chronic skin diseases like psoriasis. However, for many other conditions—such as atopic dermatitis, chronic urticaria, and alopecia areata—early-phase clinical drug development remains fraught with challenges.

This text outlines a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars: pharmacokinetics (PK), pharmacodynamics (PD), sensitive and objective clinical endpoints, integrated multimodal profiling, and collaborative trial networks. Advances in dermal PK techniques (e.g., microdialysis, Raman spectroscopy), translational PD models, and sensitive digital endpoints (e.g., digital PASI, imaging biomarkers) now offer robust tools to assess drug effects more precisely. The integration of omics data and patient-reported outcomes supports a systems dermatology approach, enabling deep phenotyping and mechanistic insights. Additionally, strong clinical trial networks like CONNECTED and UKDCTN play a pivotal role in accelerating recruitment and maintaining high data quality. Together, these strategies aim to improve efficiency, personalization, and scientific rigor in dermatological drug development, ultimately enhancing the probability of success for new treatments in early-phase trials while ensuring patient-centered, data-rich study designs.

© 2020 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society

First published: 06 April 2020 - https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.14293