January 29, 2019

Study investigators sought to determine if erythema assessment and percentage of ≥1-grade CEA improvement over time altered when assessment included a baseline facial photograph.

Introducing a baseline photograph to the critical evaluation of erythema reduction in clinical trials of oxymetazoline confirmed similar results, but led to significantly fewer participants achieving ≥1-grade Clinician Erythema Assessment (CEA) improvement, according to a study published in the British Journal of Dermatology.

Two phase 3 clinical trials of the once a day, topical cream oxymetazoline 1% showed that treatment significantly reduced facial erythema for patients with rosacea. These trials were identically designed and randomized and required live, static assessments of patients being treated once daily with oxymetazoline or vehicle. Study investigators sought to determine if erythema assessment and percentage of ≥1-grade CEA improvement over time altered when assessment included referring to a standardized, digital, baseline facial photograph.

Of the total 835 trial participants (oxymetazoline, n=415; vehicle, n=420), a significantly greater proportion of the oxymetazoline participants achieved ≥1-grade CEA improvement compared with vehicle (up to 85.3% vs 29.8%; P <.0001). When baseline photographs were used for reference during the evaluation of posttreatment photographs, oxymetazoline results were similar to phase 3 trial results, but with a significantly lower rate of ≥1-grade CEA improvement (up to 52.3% vs 29.7%; P <.001). At least a moderate improvement in erythema was achieved by up to 80.2% of oxymetazoline participants compared with up to 22.9% of vehicle participants, with a statistically significant association between participant satisfaction with facial redness and the percentage of erythema improvement (Spearman rank correlation, oxymetazoline, 0.1824; P <.0001; vehicle, 0.0623; P =.01).

Study investigators conclude, “In this study, a greater percentage of patients achieved improvement in persistent facial erythema of rosacea from baseline on the first day of application with oxymetazoline than with vehicle when investigators were allowed to reference the patient’s baseline photograph while evaluating posttreatment photographs to assess erythema severity over time.”

Disclosures: Study funding was provided by Allergan plc, Dublin, Ireland.

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Reference

Eichenfield LF, Del Rosso JQ, Tan JKL, et al. 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 [published online November 30, 2018]. Br J Dermatol. doi: 10.1111/bjd.17462