Oxymetazoline cream 1.0% once daily for the treatment of persistent facial erythema associated with rosacea was the optimal dosing regimen, according to the results of a phase 2 study (ClinicalTrials.gov identifier: NCT01735201) conducted at 15 centers in the United States from December 2012 to June 2013 and published in the Journal of Drugs in Dermatology.
The objective of the current study was to evaluate the optimal oxymetazoline dosing regimen for patients with moderate to severe persistent facial erythema associated with rosacea.
Participants were randomly assigned to treatment with oxymetazoline cream 0.5%, 1.0%, 1.5%, or vehicle, administered once or twice daily for 28 consecutive days. The primary efficacy end point of the study was the proportion of patients with ≥2-grade improvement from baseline on the Clinician Erythema Assessment and the Subject Self-Assessment of erythema on day 28.
The intent-to-treat and safety populations comprised a total of 356 patients, including 177 who were randomly assigned to the once-daily group and 179 who were randomly assigned to the twice-daily group. Mean age of the participants was 50.0 years; 80.1% of the patients were women.
Overall, the proportions of participants who attained the primary end point were significantly higher with oxymetazoline 0.5% once daily (P =.049), oxymetazoline 1.0% once daily (P =.006), oxymetazoline 1.5% once daily (P =.012), oxymetazoline 1.0% twice daily (P =.021), and oxymetazoline 1.5% twice daily (P =.006), compared with their respective vehicles. Regarding both once- and twice-daily dosing, the efficacy of oxymetazoline 1.0% was greater than that of the 0.5% dose and comparable to that of the 1.5% dose.
The safety and tolerability profile of oxymetazoline cream was shown to be favorable. The incidence and types of treatment-emergent adverse events were generally comparable with those of oxymetazoline and vehicle. Treatment-emergent application-site events, however, specifically dermatitis, erythema, pruritus, and papules, were reported among several patients in the oxymetazoline arms but not in the vehicle arms.
The investigators concluded that twice-daily dosing of oxymetazoline cream did not offer any significant improvements in clinical efficacy compared with once-daily dosing. Based on the study findings, oxymetazoline 1.0% once daily provided the optimal dosing regimen with respect to efficacy, safety, and tolerability, and was thus selected for evaluation in phase 3 clinical studies.
DuBois J, Dover JS, Jones TM, Weiss RA, Berk DR, Ahluwalia G. Phase 2 randomized, dose-ranging study of oxymetazoline cream for treatment of persistent facial erythema associated with rosacea. J Drugs Dermatol. 2018;17(3):308-316.