Title

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.

Document Type

Article

Publication Date

11-30-2018

Publication Title

The British journal of dermatology

Abstract

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.

PubMed ID

30500065

ePublication

ePub ahead of print

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