Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults.
J Am Acad Dermatol
; 75(3): 494-503.e6, 2016 Sep.
Article
em En
| MEDLINE
| ID: mdl-27417017
ABSTRACT
BACKGROUND:
Additional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks.OBJECTIVE:
We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301 NCT02118766; AD-302 NCT02118792).METHODS:
Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (21, crisaborolevehicle) patients aged 2 years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days. The primary end point was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus.RESULTS:
More crisaborole- than vehicle-treated patients achieved ISGA score success (clear/almost clear with ≥2-grade improvement; AD-301 32.8% vs 25.4%, P = .038; AD-302 31.4% vs 18.0%, P < .001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001). Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle (both P ≤ .001). Treatment-related adverse events were infrequent and mild to moderate in severity.LIMITATIONS:
Short study duration was a limitation.CONCLUSIONS:
Crisaborole demonstrated a favorable safety profile and improvement in all measures of efficacy, including overall disease severity, pruritus, and other signs of AD.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Compostos de Boro
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Compostos Bicíclicos Heterocíclicos com Pontes
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Dermatite Atópica
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Fármacos Dermatológicos
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Nucleotídeo Cíclico Fosfodiesterase do Tipo 4
Tipo de estudo:
Clinical_trials
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Etiology_studies
Limite:
Adolescent
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Adult
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Aged
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Child
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Child, preschool
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article