Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trial.
J Am Acad Dermatol
; 82(6): 1321-1327, 2020 Jun.
Article
en En
| MEDLINE
| ID: mdl-32068049
ABSTRACT
BACKGROUND:
Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.OBJECTIVE:
To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.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:
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:
Not powered to detect changes in gravimetric sweat production.CONCLUSION:
Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Antagonistas Colinérgicos
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Hiperhidrosis
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2020
Tipo del documento:
Article