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
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. To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary ax...
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| Published in | Journal of the American Academy of Dermatology Vol. 56; no. 4; pp. 604 - 611 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York, NY
Mosby, Inc
01.04.2007
Elsevier |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0190-9622 1097-6787 1097-6787 |
| DOI | 10.1016/j.jaad.2007.01.009 |
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| Abstract | 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.
To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis.
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.
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.
The effect of total surface area involvement on treatment efficacy was not evaluated.
BoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated. |
|---|---|
| AbstractList | 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.
To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis.
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.
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.
The effect of total surface area involvement on treatment efficacy was not evaluated.
BoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated. 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. To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis. 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. 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. The effect of total surface area involvement on treatment efficacy was not evaluated. BoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated. 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. 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.BACKGROUNDThe 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.To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis.OBJECTIVETo assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis.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.METHODSSubjects (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.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.RESULTSBoNTA 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.The effect of total surface area involvement on treatment efficacy was not evaluated.LIMITATIONSThe effect of total surface area involvement on treatment efficacy was not evaluated.BoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated.CONCLUSIONBoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated. |
| Author | Kowalski, Jonathan W. Glaser, Dee Anna Daggett, Simon Lai, Pan-Yu Eadie, Nina Lowe, Nicholas J. |
| Author_xml | – sequence: 1 givenname: Nicholas J. surname: Lowe fullname: Lowe, Nicholas J. email: cranleyuk@aol.com organization: From the University of California Los Angeles School of Medicine and Clinical Research Specialists – sequence: 2 givenname: Dee Anna surname: Glaser fullname: Glaser, Dee Anna organization: Saint Louis University Medical Center – sequence: 3 givenname: Nina surname: Eadie fullname: Eadie, Nina organization: Allergan Inc – sequence: 4 givenname: Simon surname: Daggett fullname: Daggett, Simon organization: Allergan Inc – sequence: 5 givenname: Jonathan W. surname: Kowalski fullname: Kowalski, Jonathan W. organization: Allergan Inc – sequence: 6 givenname: Pan-Yu surname: Lai fullname: Lai, Pan-Yu organization: Allergan Inc |
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| Copyright | 2007 American Academy of Dermatology, Inc. American Academy of Dermatology, Inc. 2007 INIST-CNRS |
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| Keywords | DLQI HRQOL BoNTA HDSS Dermatology Life Quality Index Hyperhidrosis Disease Severity Scale health-related quality of life botulinum toxin type A Skin disease Enzyme Dermatology Toxicity Metalloendopeptidases Peptidases Bontoxilysin Hyperhidrosis Treatment Primary Axilla Double blind study Hydrolases Safety Sweat gland disease |
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| Snippet | The long-term effects of botulinum toxin type A (BoNTA) on the global impairment associated with severe primary axillary hyperhidrosis have not been... Background The long-term effects of botulinum toxin type A (BoNTA) on the global impairment associated with severe primary axillary hyperhidrosis have not been... |
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| SubjectTerms | Adolescent Adult Aged Axilla Biological and medical sciences Botulinum Toxins, Type A - administration & dosage Botulinum Toxins, Type A - adverse effects Confidence Intervals Cross-Over Studies Dermatology Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Follow-Up Studies Humans Hyperhidrosis - diagnosis Hyperhidrosis - drug therapy Injections, Intradermal Male Medical sciences Middle Aged Probability Quality of Life Risk Factors Severity of Illness Index Skin involvement in other diseases. Miscellaneous. General aspects Statistics, Nonparametric Treatment Outcome |
| Title | 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 |
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