Journal of the American Academy of Dermatology · 2007
Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: a 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Lowe Nicholas J, Glaser Dee Anna, Eadie Nina, Daggett Simon, Kowalski Jonathan W, Lai Pan-Yu, North American Botox in Primary Axillary Hyperhidrosis Clinical Study Group
Аннотация
BACKGROUND: The long-term effects of botulinum toxin type A (BoNTA) on the global impairment associated with severe primary axillary hyperhidrosis have not been comprehensively assessed relative to placebo.
OBJECTIVE: To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis.
METHODS: Subjects (N = 322) were randomized to the use of BoNTA (75 U or 50 U/axilla) or placebo in this 52-week, multicenter, double-blind study.
RESULTS: BoNTA treatment significantly reduced daily activity limitations at 4 weeks after injection. A 2-point improvement on the 4-point Hyperhidrosis Disease Severity Scale (HDSS) was reported in 75% of subjects in the 75-U and 50-U BoNTA groups and in 25% of the placebo group (P < .001). Improvements in HDSS scores were corroborated by gravimetric results. The median duration of effect was 197 days, 205 days, and 96 days in the 75-U, 50-U, and placebo groups, respectively. BoNTA was well tolerated.
LIMITATIONS: The effect of total surface area involvement on treatment efficacy was not evaluated.
CONCLUSION: BoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated.
OBJECTIVE: To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis.
METHODS: Subjects (N = 322) were randomized to the use of BoNTA (75 U or 50 U/axilla) or placebo in this 52-week, multicenter, double-blind study.
RESULTS: BoNTA treatment significantly reduced daily activity limitations at 4 weeks after injection. A 2-point improvement on the 4-point Hyperhidrosis Disease Severity Scale (HDSS) was reported in 75% of subjects in the 75-U and 50-U BoNTA groups and in 25% of the placebo group (P < .001). Improvements in HDSS scores were corroborated by gravimetric results. The median duration of effect was 197 days, 205 days, and 96 days in the 75-U, 50-U, and placebo groups, respectively. BoNTA was well tolerated.
LIMITATIONS: The effect of total surface area involvement on treatment efficacy was not evaluated.
CONCLUSION: BoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated.
Предметные рубрики MeSH
AdolescentAdultAgedAxillaBotulinum Toxins, Type AConfidence IntervalsCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansHyperhidrosisInjections, IntradermalMaleMiddle AgedProbabilityQuality of LifeRisk FactorsSeverity of Illness IndexStatistics, NonparametricTreatment Outcome