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.
J Am Acad Dermatol
; 78(6): 1156-1163, 2018 Jun.
Article
en En
| MEDLINE
| ID: mdl-29409914
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.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Oximetazolina
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Rosácea
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Eritema
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Dermatosis Facial
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Seguridad del Paciente
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Observational_studies
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Risk_factors_studies
Límite:
Adolescent
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Adult
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
America do norte
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2018
Tipo del documento:
Article