Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trial.
Adult
Axilla
Cholinergic Antagonists
/ adverse effects
Double-Blind Method
Female
Gels
Glycopyrrolate
/ analogs & derivatives
Humans
Hyperhidrosis
/ drug therapy
Male
Middle Aged
Severity of Illness Index
Sweat
/ metabolism
Vision Disorders
/ chemically induced
Xerostomia
/ chemically induced
Young Adult
HDSM-Ax
anticholinergic
axillary hyperhidrosis
retrometabolic drug
sofpironium bromide
topical
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
03
09
2019
revised:
03
02
2020
accepted:
06
02
2020
pubmed:
19
2
2020
medline:
22
1
2021
entrez:
19
2
2020
Statut:
ppublish
Résumé
Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options. To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide. A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to 1 of 3 dosages or vehicle, with daily treatment for 42 days. Coprimary end points were the percentage of participants exhibiting ≥1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score by logistic regression, and change in HDSM-Ax as a continuous measure by analysis of covariance. Pair-wise comparisons were 1-sided with α = 0.10. At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P < .05). Least-square mean (SE) changes in HDSM-Ax were -2.02 (0.14), -2.09 (0.14), 2.10 (0.14), and -1.30 (0.14) (all P ≤ .0001). Most treatment-related adverse events were mild or moderate. Not powered to detect changes in gravimetric sweat production. Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.
Sections du résumé
BACKGROUND
BACKGROUND
Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.
OBJECTIVE
OBJECTIVE
To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.
METHODS
METHODS
A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to 1 of 3 dosages or vehicle, with daily treatment for 42 days. Coprimary end points were the percentage of participants exhibiting ≥1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score by logistic regression, and change in HDSM-Ax as a continuous measure by analysis of covariance. Pair-wise comparisons were 1-sided with α = 0.10.
RESULTS
RESULTS
At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P < .05). Least-square mean (SE) changes in HDSM-Ax were -2.02 (0.14), -2.09 (0.14), 2.10 (0.14), and -1.30 (0.14) (all P ≤ .0001). Most treatment-related adverse events were mild or moderate.
LIMITATIONS
CONCLUSIONS
Not powered to detect changes in gravimetric sweat production.
CONCLUSION
CONCLUSIONS
Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.
Identifiants
pubmed: 32068049
pii: S0190-9622(20)30224-3
doi: 10.1016/j.jaad.2020.02.016
pii:
doi:
Substances chimiques
Cholinergic Antagonists
0
Gels
0
Glycopyrrolate
V92SO9WP2I
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1321-1327Informations de copyright
Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.