Developing a Core Outcome Set for Acne Clinical Trials: Towards Standardization and Harmonization

Clinical trial results should address outcomes that matter to patients and their clinicians. The legacy of inadequate external validity of outcome measures in clinical trials extends across all fields of medicine and is a waste of resources. It also represents a lost opportunity to generalize findings to facilitate comparative effectiveness research. The minimal set of outcome measures that should be included in all clinical trials of a target condition is termed a core outcome set (COS). This should comprise all relevant outcome domains (i.e. what to measure) and their respective measures (how to measure). The methodology for COS development and dissemination has been previously extensively detailed and is increasingly being applied to various dermatological conditions including acne, atopic dermatitis, psoriasis and hidradenitis suppurativa.