Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: Findings from the 52-week open label REVEAL trial - 12/05/18
Abstract |
Background |
Limited treatments are available for persistent erythema of rosacea.
Objective |
To examine the long-term safety and efficacy of oxymetazoline cream 1.0% in patients with rosacea with moderate-to-severe persistent erythema.
Methods |
Patients applied oxymetazoline once daily for 52 weeks. Safety assessments included treatment-emergent adverse events (TEAEs), skin blanching, inflammatory lesion counts, telangiectasia, disease severity, and rebound effect. Efficacy was assessed by the Clinician Erythema Assessment and Subject Self-Assessment composite score at 3 and 6 hours after the dose on day 1 and at weeks 4, 26, and 52.
Results |
Among 440 patients, 8.2% reported treatment-related TEAEs; the most common were application-site dermatitis, paresthesia, pain, and pruritus. The rate of discontinuation due to adverse events (mostly application-site TEAEs) was 3.2%. No clinically meaningful changes were observed in skin blanching, inflammatory lesions, or telangiectasia. At week 52, 36.7%, and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively. Less than 1% of patients experienced a rebound effect following treatment cessation.
Limitations |
A vehicle-control group was not included.
Conclusion |
This long-term study demonstrated sustained safety, tolerability, and efficacy of oxymetazoline for moderate-to-severe persistent erythema of rosacea.
Le texte complet de cet article est disponible en PDF.Key words : α-adrenergic receptors, β-adrenergic receptors, facial dermatoses, skin abnormalities, vascular skin diseases, vasoconstrictor agents
Abbreviations used : AE, CEA, CTA, SSA, TEAE
Plan
Funding sources: Sponsored by Allergan plc, Dublin, Ireland. Writing and editorial assistance funded by Allergan plc. |
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Disclosure: Drs Draelos, Gold, Weiss, Baumann, Grekin, Robinson, and Kempers are investigators for Allergan plc. Drs Alvandi, Weng, Berk, and Ahluwalia are employees of Allergan plc and may own stock/stock options in that company. |
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The authors did not receive honoraria or any other form of compensation for authorship or other activities related to preparation or submission of this manuscript. |
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Reprints not available from the authors. |
Vol 78 - N° 6
P. 1156-1163 - juin 2018 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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