Study: Topical Hyperhidrosis Treatment Effective and Safe for Pediatric Patients
A recent study by Hebert and colleagues demonstrated that topical glycopyrronium tosylate (GT) is a safe and effective treatment for primary axillary hyperhidrosis among pediatric participants. The study findings were presented at the 2018 American Academy of Dermatology Annual Meeting.
“Topically applied GT was well tolerated and improved disease severity, sweat production, and quality of life, with similar findings in pediatric participants vs the older cohort. The treatment-emergent adverse events were similar across age groups and consistent with anticholinergics,” the researchers reported.
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The study evaluated data from 2 four-week randomized vehicle-controlled trials that included 697 participants with hyperhidrosis. It compared the safety and efficacy of GT among participants aged 16 years and younger (pediatric) and participants older than 16 years of age. The primary outcome included the percentage of participants who achieved a 4-point or greater improvement on the Axillary Sweating Daily Diary (ASDD/ASDD-Child [ASDD-C]).
A total of 463 participants were randomly assigned to receive GT and 234 were randomly assigned to receive vehicle (VEH). Forty-four participants were aged 16 years and younger, 25 pediatric participants received GT and 19 pediatric participants received VEH.
The pooled responder rates on the ASDD/ASDD-C of participants who received GT were 59.9% among the pediatric cohort and 60.2% among the older cohort. Among participants who received VEH, the pooled responder rates were 13% among the pediatric cohort and 28.8% among the older cohort. Likewise, 79.9% of pediatric participants and 74.3% of older participants who received GT achieved a 50% or more reduction in sweat production compared with those who received VEH (54.8% and 53%, respectively).
The mean decrease in Children’s Dermatology Life Quality Index was consistent with the mean decrease in the Dermatology Life Quality Index.
In addition, TEAEs were reported by 44% of pediatric participants treated with GT and 56.7% of older participants treated with GT compared with 10.5% of pediatric participants and 34.3% of older participants treated with VEH. TEAEs were mostly related to anticholinergic activity and were mild, short-lived, and rarely led to drug discontinuation.
Hebert AA, Glaser DA, Green L, et al. Glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: pediatric subgroup analyses from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials. Presented at: The American Academy of Dermatology Annual Meeting; February 16-20, 2018; San Diego, CA.