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
, Michael H. Gold, MD b, Robert A. Weiss, MD c, Leslie Baumann, MD d, Steven K. Grekin, DO e, Deanne Mraz Robinson, MD f, Steven E. Kempers, MD g, Nancy Alvandi, PhD h, Emily Weng, ScD, MBA h, David R. Berk, MD h, Gurpreet Ahluwalia, PhD hAbstract |
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 numéro
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