Patients were able to tolerate treatment of their rosacea with topical 1% oxymetazoline hydrochloride gel for 1 year with acceptable reduction of redness and few adverse events, according to a study presented here at the 75th Annual Meeting of the American Academy of Dermatology (AAD).
"Over the entire 52-week period, oxymetazoline applied topically was associated with a low incidence of treatment-emergent adverse events, low rates of discontinuations due to adverse events, and an acceptable dermal tolerability profile," reported Zoe Diana Draelos, MD, Dermatology Consulting Services, High Point, North Carolina.
At her oral poster presentation on March 4, Dr. Draelos reported that worsening of erythema was observed in less than 1% of patients at week 52 pre-dose and week 54 post-treatment.
"Findings from this long-term, open-label study demonstrated the safety and continued efficacy of oxymetazoline cream 1.0% for the treatment of patients with moderate to severe persistent erythema associated with rosacea," said Dr. Draelos. "Based on the overall adverse events profile and rigorous evaluation of worsening of erythema following cessation of treatment, there appears to be minimal evidence for oxymetazoline to cause a rebound effect."
The researchers enrolled 440 patients to determine the long-term safety of oxymetazoline cream in patients diagnosed with persistent facial erythema associated with rosacea Patients applied a pea-sized dollop of oxymetazoline as a thin layer to the entire face, including the forehead, nose, chin, and cheeks once daily in the morning. The study was conducted at 25 centres in the United States.
Oxymetazoline cream 1.0%, which is approved by the US Food and Drug Administration (FDA) for persistent facial erythema associated with rosacea in adults, acts as a ?1A-adrenoceptor agonist resulting in vasoconstriction of cutaneous microvasculature.
The patients in the study had a mean age of 53 years, 76% were women, 91% were white, and 89% had moderate facial redness.
Funding for this study was provided by Allergan plc.
[Presentation title: Long-Term Safety and Efficacy of Topical Oxymetazoline Cream 1.0% for Treatment of Persistent Facial Erythema Associated With Rosacea. Abstract 5368]