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Br J Dermatol. 2018 Nov 30. doi: 10.1111/bjd.17462. [Epub ahead of print]

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.

Author information

1
University of California, San Diego and Rady Children's Hospital, San Diego, CA.
2
JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV.
3
Windsor Clinical Research Inc, Windsor, ON.
4
UTHealth McGovern Medical School, Department of Dermatology, Houston, TX.
5
Webster Dermatology, P.A, Hockessin, DE.
6
Dermatology and Skin Care Center of Birmingham, Birmingham, AL.
7
The Acne Treatment and Research Center, Morristown, NJ.
8
DermResearch, PLLC, Louisville, KY.
9
Icahn School of Medicine at Mount Sinai, New York, NY.
10
Henry Ford Health System, West Bloomfield, MI.
11
Allergan plc, Irvine, CA.

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<0.0001) achieved ≥1-grade CEA improvement (up to 85.3% vs 29.8%). When reference to baseline photographs was allowed while evaluating posttreatment photographs, the results for oxymetazoline were similar to results of the phase 3 trials, but a significantly lower proportion of vehicle recipients achieved ≥1-grade CEA improvement (up to 52.3% vs 29.7%; P<0.001). Up to 80.2% of oxymetazoline patients achieved at least moderate erythema improvement, versus up to 22.9% of vehicle patients. The association between patients' satisfaction with facial skin redness and percentage of erythema improvement was statistically significant (Spearman rank correlation, 0.1824; P<0.0001 [oxymetazoline]; 0.0623; P=0.01 [vehicle]).

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.

KEYWORDS:

alpha adrenergic receptors; dermatology; facial dermatoses; oxymetazoline; placebo effect; research design; research methodology; rosacea; topical administration; vasoconstrictor agents

PMID:
30500065
DOI:
10.1111/bjd.17462

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