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.

CONCLUSION:

OnabotulinumtoxinA injections provided beneficial effects in adolescents with primary axillary hyperhidrosis.

• Authors: Dee Anna Glaser, David M Pariser, Adelaide A Hebert, Ian Landells, Chris Somogyi, Emily Weng, Mitchell F Brin, Frederick Beddingfield
• Journal: Pediatric dermatology (Pediatr Dermatol) 2015 Sep-Oct Vol. 32 Issue 5 Pg. 609-17 ISSN: 1525-1470 [Electronic] United States
• PMID: 26059781 (Publication Type: Controlled Clinical Trial, Journal Article, Multicenter Study)
• Copyright: © 2015 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.

Chemical References

• Botulinum Toxins, Type A

Topics

• Adolescent
• Axilla
• Botulinum Toxins, Type A (administration & dosage, adverse effects)
• Child
• Confidence Intervals
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Hyperhidrosis (diagnosis, drug therapy, psychology)
• Injections, Intralesional
• Injections, Subcutaneous
• Male
• Patient Safety
• Quality of Life
• Statistics, Nonparametric
• Treatment Outcome