| Autor: |
Linda, Stein-Gold, Leon, Kircik, Zoe Diana, Draelos, Philip, Werschler, Janet, DuBois, Edward, Lain, Leslie, Baumann, David, Goldberg, Joely, Kaufman, Emil, Tanghetti, Gurpreet, Ahluwalia, Nancy, Alvandi, Emily, Weng, David, Berk |
| Rok vydání: |
2018 |
| Předmět: |
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| Zdroj: |
Journal of drugs in dermatology : JDD. 17(11) |
| ISSN: |
1545-9616 |
| Popis: |
Background: Rosacea is a chronic dermatologic condition with limited treatment options. Methods: Data were pooled from two identically designed phase 3 trials. Patients with moderate to severe persistent erythema of rosacea were randomized to receive oxymetazoline cream 1.0% or vehicle once daily for 29 days and were followed for 28 days posttreatment. The primary efficacy outcome was the proportion of patients with ≥2-grade improvement from baseline on both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) at 3, 6, 9, and 12 hours postdose, day 29. Results: The pooled population included 885 patients (78.8% female); 85.8% and 91.2% had moderate erythema based on CEA and SSA, respectively. The primary outcome was achieved by significantly more patients in the oxymetazoline than vehicle group (P0.001). Individual CEA and SSA scores and reduction in facial erythema (digital image analysis) favored oxymetazoline over vehicle (P0.001). The incidence of treatment-emergent adverse events was low (oxymetazoline, 16.4%; vehicle, 11.8%). No clinically relevant erythema worsening (based on CEA and SSA) was observed during the 28-day posttreatment follow-up period (oxymetazoline, 1.7%; vehicle, 0.6%). Conclusion: Oxymetazoline effectively reduced moderate to severe persistent facial erythema of rosacea and was well tolerated. J Drugs Dermatol. 2018;17(11):1201-1208. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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