Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1·0% for persistent erythema of rosacea in a phase IV study.
Br J Dermatol. 2019 05;180(5):1050-1057
Authors: Eichenfield LF, Del Rosso JQ, Tan JKL, Hebert AA, Webster GF, Harper J, Baldwin HE, Kircik LH, Stein-Gold L, Kaoukhov A, Alvandi N
Abstract
BACKGROUND: Once-daily topical oxymetazoline cream 1·0% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments.
OBJECTIVES: To evaluate critically the methodology of clinical trials that require live, static patient assessments by determining whether assessment of erythema is different when reference to the baseline photograph is allowed.
METHODS: In two identically designed, randomized, phase III trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase IV study evaluated standardized digital facial photographs from the phase III trials to record ?*1-grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9 and 12*h postdose.
RESULTS: Among 835 patients (oxymetazoline n*=*415, vehicle n*=*420), significantly greater proportions of patients treated with oxymetazoline vs. vehicle achieved ?*1-grade CEA improvement. For the comparison between phase IV study results and the original phase III analysis, when reference to baseline photographs was allowed while evaluating post-treatment photographs, the results for oxymetazoline were similar to results of the phase III trials (up to 85.7%), but a significantly lower proportion of vehicle recipients achieved ?*1-grade CEA improvement (up to 29.7% [phase 4] vs. 52.3% [phase 3]; P