The use of topical oxymetazoline hydrochloride cream 1.0% is a safe and effective treatment option for reducing moderate to severe persistent facial erythema associated with rosacea, according to the results of two identically designed, phase 3, multicenter, randomized, double-blind, parallel-group, vehicle-controlled, 29-day trials (REVEAL; ClinicalTrials.gov identifiers: NCT02131636 and NCT02132117) conducted in the United States and published in the Journal of the American Academy of Dermatology.
Data were pooled from the two REVEAL trials. In both studies, participants were randomly assigned to treatment with oxymetazoline or vehicle once daily for 29 days and were followed for 28 days post-treatment.
The primary efficacy outcome was the proportion of patients with ≥2-grade improvement from baseline on both the Clinical Erythema Assessment (CEA) and Subject Self-Assessment (SSA) scales at 3, 6, 9, and 12 hours post-dose, and on day 29.
A total of 885 patients were in the pooled population; 78.8% were women and mean patient age was 49.9. Of the participants, 85.8% and 91.2% had moderate erythema, according to CEA and SSA scores, respectively. The primary outcome was attained by significantly more participants in the oxymetazoline group compared with the vehicle group (P <.001). In addition, individual CEA and SSA scores, as well as a reduction in facial erythema (per digital image analysis), were significantly associated with oxymetazoline therapy (P <.001).
The occurrence of treatment-emergent adverse events was low in both groups (16.4% with oxymetazoline; 11.8% with vehicle). Based on CEA and SSA scores, no clinically relevant worsening of erythema was reported during the 28-day post-treatment follow-up period (1.7% with oxymetazoline; 0.6% with vehicle).
The investigators concluded that oxymetazoline cream 1% applied topically to the face once daily for 29 days reduced moderate to severe persistent erythema linked to rosacea and had an acceptable dermal tolerability profile that was similar to that of vehicle. No clinically relevant rebound effect was reported following treatment cessation.
Stein-Gold L, Kircik LH, Draelos ZD, et al. Efficacy and safety of topical oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: findings from the two phase 3, 29-day, randomized, controlled REVEAL trials [published online January 30, 2018]. J Am Acad Dermatol. doi:10.1016/j.jaad.2018.01.028