Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: Results of 2 phase 3 randomized controlled trials.
J Am Acad Dermatol
; 79(2): 287-293, 2018 Aug.
Article
en En
| MEDLINE
| ID: mdl-29614243
ABSTRACT
BACKGROUND:
Topical corticosteroids are the mainstay of psoriasis treatment, with long-term safety considerations limiting their use. Combining them with tazarotene may optimize their efficacy and minimize safety and tolerability concerns.OBJECTIVE:
To investigate the safety and efficacy of halobetasol propionate 0.01% plus tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis.METHODS:
Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N = 418) were conducted. Subjects were randomized (21) to HP/TAZ lotion or vehicle once daily for 8 weeks with a 4-week follow-up. The primary efficacy assessment end point was treatment success (at least a 2-grade improvement from baseline in Investigator's Global Assessment score and a score of clear or almost clear). Safety and treatment-emergent adverse events were evaluated throughout.RESULTS:
HP/TAZ lotion demonstrated statistically significant superiority over vehicle within as few as 2 weeks. By week 8, 35.8% (study 1) and 45.3% (study 2) of subjects were treatment successes compared with 7.0% and 12.5% of those treated with vehicle (P < .001). HP/TAZ lotion was also superior in reducing signs and symptoms of psoriasis and body surface area affected by psoriasis. The most frequently reported treatment-related adverse events were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%).LIMITATIONS:
Studies did not include subjects with more than 12% of their body surface area affected by psoriasis.CONCLUSIONS:
HP/TAZ lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, with no safety concerns.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Psoriasis
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Clobetasol
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Fármacos Dermatológicos
/
Ácidos Nicotínicos
Tipo de estudio:
Clinical_trials
Límite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2018
Tipo del documento:
Article