title: A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of onabotulinumtoxinA in adolescents with primary axillary hyperhidrosis.
  
  
  METHODS
  This 52-week, multicenter, nonrandomized, open-label study was conducted in 141 adolescents ages 12 to 17 years with severe primary axillary hyperhidrosis. Patients could receive up to six treatments with onabotulinumtoxinA (50 U per axilla), with re-treatment occurring no sooner than 8 weeks after the prior treatment cycle and no later than 44 weeks after the initial treatment cycle. The primary efficacy measure was treatment response, based on self-assessed hyperhidrosis severity following the first two treatments using the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Other efficacy measures included spontaneous resting sweat production and health outcomes.
  
  
  RESULTS
  Fifty-six (38.9%) participants underwent one treatment, 59 (41.0%) underwent two, 20 (13.9%) underwent three, 6 (4.2%) underwent four, and 3 (2.1%) underwent five. OnabotulinumtoxinA significantly improved HDSS scores and decreased sweat production compared with treatment cycle baselines. Seventy-nine patients (54.9%) responded to treatment based on HDSS criteria. From 56.6% to 72.3% of patients experienced a two-grade or more improvement at 4 and 8 weeks after each of the first two treatments. The majority (79.4%-93.2%) had a 75% or greater reduction in sweat production at week 4 (treatments 1-3). The median duration of effect for responders ranged from 134 to 152 days. Using quality of life measures, health outcomes improved markedly. Eight patients (5.6%) had mild or moderate treatment-related adverse events. No unexpected safety signals were observed in this study. Neutralizing antibodies to onabotulinumtoxinA did not develop.
  
  
  CONCLUSIONS
  OnabotulinumtoxinA injections provided beneficial effects in adolescents with primary axillary hyperhidrosis.
authors.affiliation: Department of Dermatology, Saint Louis University, St. Louis, Missouri.
authors.forename: Dee Anna
authors.initials: DA
authors.lastname: Glaser
authors.affiliation: Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia.|Virginia Clinical Research, Inc., Norfolk, Virginia.
authors.forename: David M
authors.initials: DM
authors.lastname: Pariser
authors.affiliation: Department of Dermatology, University of Texas-Houston Medical School, Houston, Texas.
authors.forename: Adelaide A
authors.initials: AA
authors.lastname: Hebert
authors.affiliation: Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
authors.forename: Ian
authors.initials: I
authors.lastname: Landells
authors.affiliation: Allergan, Inc., Irvine, California.
authors.forename: Chris
authors.initials: C
authors.lastname: Somogyi
authors.affiliation: Allergan, Inc., Irvine, California.
authors.forename: Emily
authors.initials: E
authors.lastname: Weng
authors.affiliation: Allergan, Inc., Irvine, California.|Department of Neurology, University of California at Irvine, Irvine, California.
authors.forename: Mitchell F
authors.initials: MF
authors.lastname: Brin
authors.affiliation: Allergan, Inc., Irvine, California.|Division of Dermatology, Department of Medicine, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.
authors.forename: Frederick
authors.initials: F
authors.lastname: Beddingfield
mesh_terms: D000293:Adolescent; D001365:Axilla; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006945:Hyperhidrosis / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D015552:Injections, Intralesional; D007279:Injections, Subcutaneous; D008297:Male; D061214:Patient Safety; D011788:Quality of Life; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D019274:Botulinum Toxins, Type A