Comparing baseline and posttreatment images of facial erythema following treatment with oxymetazoline may help improve the accuracy of rosacea clinical trial evaluations going forward, according to study results published in the British Journal of Dermatology.
Two phase 3 clinical trials of once daily, topical 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 with oxymetazoline or vehicle. Study investigators sought to determine if erythema assessment and percentage of patients achieving ≥1-grade Clinician Erythema Assessment (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 patients who received oxymetazoline 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, results for those who received oxymetazoline were similar to phase 3 trial results; however, a significantly lower proportion of patients who received vehicle were recorded as having ≥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 the oxymetazoline group compared with up to 22.9% of the vehicle group, 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).
“These observations suggest that this methodology, which allows for comparison to baseline photographs, may improve the accuracy of clinical trials that evaluate erythema severity,” the authors concluded.
Disclosures: Study funding was provided by Allergan plc, Dublin, Ireland.
EDITOR’S NOTE: This article has been updated to better reflect study results that suggest that use of both baseline and posttreatment photographs for comparison of facial erythema improvement allow for more accurate assessment and clinical grading of improvements.
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