Journal of drugs in dermatology : JDD · 2006
A multicenter, randomized, vehicle-controlled clinical study to examine the efficacy and safety of MAS063DP (Atopiclair) in the management of mild to moderate atopic dermatitis in adults.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Abramovits William, Boguniewicz Mark, Adult Atopiclair Study Group
Аннотация
BACKGROUND: MAS063DP cream has received marketing authorization in the US and the European Union for symptom relief of atopic dermatitis (eczema) and contact dermatitis.
DESIGN: A multicenter, randomized, vehicle-controlled, phase IV study was completed in the US.
METHODS: 218 patients aged 18 to 84 years joined this 50-day study. Patients self-administered MAS063DP cream (N=145) or vehicle cream (N=73) 3 times per day to affected areas and those areas prone to be affected. The primary endpoint for efficacy was the change in EASI at Day 22 of treatment, comparing the 2 treatment groups. Secondary outcomes included EASI scores at other time points, IGA, pruritus (100mm VAS), % BSA, and the need for rescue medication.
RESULTS: MAS063DP was statistically (p<.0001) more effective than vehicle in all outcomes at all time points. The incidence of rash was 2.1% in the MAS063DP group versus 5.5% in the vehicle group. Only 2 patients discontinued MAS063DP due to an adverse event.
CONCLUSION: MAS063DP cream was confirmed to be a safe and effective treatment for mild to moderate atopic dermatitis in adults.
DESIGN: A multicenter, randomized, vehicle-controlled, phase IV study was completed in the US.
METHODS: 218 patients aged 18 to 84 years joined this 50-day study. Patients self-administered MAS063DP cream (N=145) or vehicle cream (N=73) 3 times per day to affected areas and those areas prone to be affected. The primary endpoint for efficacy was the change in EASI at Day 22 of treatment, comparing the 2 treatment groups. Secondary outcomes included EASI scores at other time points, IGA, pruritus (100mm VAS), % BSA, and the need for rescue medication.
RESULTS: MAS063DP was statistically (p<.0001) more effective than vehicle in all outcomes at all time points. The incidence of rash was 2.1% in the MAS063DP group versus 5.5% in the vehicle group. Only 2 patients discontinued MAS063DP due to an adverse event.
CONCLUSION: MAS063DP cream was confirmed to be a safe and effective treatment for mild to moderate atopic dermatitis in adults.
Предметные рубрики MeSH
AdolescentAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalColoradoDermatitis, AtopicDermatologic AgentsDouble-Blind MethodDrug CombinationsFemaleGlycyrrhetinic AcidHumansHyaluronic AcidMaleMiddle AgedPlant ExtractsSeverity of Illness IndexTexasThiazolesThiazolidinesTreatment OutcomeVitis