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 4 study.

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The British journal of dermatology


BACKGROUND: Once-daily topical oxymetazoline cream 1.0% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments.

OBJECTIVE: To critically evaluate 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, randomised, phase 3 trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase 4 study evaluated standardised digital facial photographs from the phase 3 trials to record ≥1-grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9, and 12 hours postdose.

RESULTS: Among 835 patients (oxymetazoline n=415, vehicle n=420), significantly greater proportions of patients treated with oxymetazoline versus vehicle (P

CONCLUSIONS: Assessment of study photographs, with comparison to baseline, confirmed significant erythema reduction with oxymetazoline on the first day of application. Compared to the phase 3 trials results, significantly fewer vehicle recipients attained ≥1-grade CEA improvement, inferring a mitigated vehicle effect. This methodology may improve the accuracy of clinical trials evaluating erythema severity. This article is protected by copyright. All rights reserved.

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ePub ahead of print