Rosacea Severity Assessment: Review of Evaluation Methods Used in Clinical Trials

The pathophysiology underlying rosacea has not been fully elucidated. The therapeutic approach targets symptoms and is often fraught with suboptimal patient satisfaction and clinical results. Clinical trials have been executed to provide evidence-based support for the efficacy of novel rosacea treatment options. The current assessment tools used to classify the severity of rosacea in clinical trials are not standardized, limiting our ability to compare the efficacy of various treatments. A valid and reliable assessment methodology is merited to define the efficacy of newer rosacea treatments and provide a common ground for treatment comparisons. We review various rosacea severity assessment methodologies used in clinical trials, discussing findings of previous reviews and supplementing those findings with methodology used in 25 additional clinical trials published since 2014. Rosacea severity assessment is most commonly measured specifically through changes in facial erythema, followed by papules and pustular count and then telangiectasia. Visual inspection by a clinician is the most common modality of assessment of erythema, with a four-point scale as the most frequent methodology. Lesion count over the entire face is the primary mode of assessment for measuring papules and pustules, and telangiectasia measurement varied. The vast array of measurement tools and variability among numeric scales, clinical observation, and patient reports of subjective symptoms leaves the researcher and clinician without a standardized method to assess rosacea treatment and assess efficacy of novel treatments.