Abstract | OBJECTIVE: 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:
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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)
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Copyright | © 2015 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc. |
Chemical References |
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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
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