Sofpironium bromide gel improves primary axillary hyperhidrosis in pediatric patients
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Treatment with sofpironium bromide gel reduced the severity of primary axillary hyperhidrosis in a cohort of pediatric patients, according to a poster presented at South Beach Symposium Medical Dermatology Summit.
The goal of the study was to “evaluate the long-term safety, tolerability and pharmacokinetics of topically applied sofpironium bromide gel 15% for the treatment of axillary hyperhidrosis in pediatric subjects, as well as to explore efficacy,” Brandon Kirsch, MD, and colleagues wrote in the poster.
Kirsch and colleagues enrolled 21 patients with primary axillary hyperhidrosis for a duration of 6 months or longer to treatment with sofpironium bromide gel 15%. Patients first completed a 1-week safety and pharmacokinetic study and then applied the gel to each axilla daily for 24 weeks. Outcomes included sofpironium and BBI-4010 metabolite plasma concentrations, Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scores, Patient Global Assessment of Severity (PGI-S) and Change in Global Assessment of Severity (PGI-C).
Researchers did not find any evidence of drug accumulation at week 24; most subjects’ plasma concentrations “were not quantifiable,” they wrote.
Mean HDSM-Ax score decreased by 1.91 points from baseline to week 24. Researchers wrote that a 1-point decrease “represents clinically meaningful improvement.”
For PGI-S, at baseline, four patients reported “very severe,” nine patients reported “severe” and eight patients reported “moderate” underarm sweating vs. week 24, when one patient reported “moderate,” seven reported “mild” and six reported no underarm sweating. The number of patients with “moderately better” PGI-C increased from three at week 12 to four at week 24. The number of patients with “very much better” PGI-C increased from eight at week 12 to 10 at week 24.
Researchers reported that seven patients experienced mild or moderate treatment-emergent adverse events; of these, four were related to the treatment, which researchers wrote “included expected systemic anticholinergic effects (blurred vision, dry mouth, dry eyes, mydriasis) and local site reactions (pain, pruritus, rash, erythema).” Among these, two patients discontinued the study due to dry eye, dry mouth, pruritus and rash.
“In this 24-week study in the pediatric population, sofpironium bromide gel 15% appeared safe and generally well tolerated,” the researchers wrote. “There was clinically meaningful improvement in axillary hyperhidrosis.”
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Kirsch B. A multi-center, open-label extension study to assess the long-term safety, tolerability and pharmacokinetics, and explore the efficacy of sofpironium bromide gel, 15% applied topically to children and adolescents, 9 to 16 years of age, with primary axillary hyperhidrosis (BBI-4000-CL-108). Presented at: South Beach Symposium Medical Dermatology Summit; Feb. 5-7, 2021 (virtual meeting).
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