Sofpironium for Axillary Hyperhidrosis
Trial question
What is the role of sofpironium bromide gel in patients with primary axillary hyperhidrosis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
70.0% female
30.0% male
N = 281
281 patients (197 female, 84 male).
Inclusion criteria: patients with primary axillary hyperhidrosis.
Key exclusion criteria: secondary hyperhidrosis; heavy sweating triggered or worsened by menopause; indication for thoracic sympathectomy; concurrent or previous disease or treatment that might affect the efficacy and/or safety evaluation.
Interventions
N=141 sofpironium (5% sofpironium applied to both axillae once daily at bedtime for 6 weeks).
N=140 vehicle (vehicle alone applied to both axillae once daily at bedtime for 6 weeks).
Primary outcome
Proportion of patients with a Hyperhidrosis Disease Severity Score of 1-2 at end of treatment and ≥ 50% reduction in total gravimetric weight of sweat at the end of treatment, intention-to-treat analysis
53.9%
36.4%
53.9 %
40.4 %
26.9 %
13.5 %
0.0 %
Sofpironium
Vehicle
Significant
increase ▲
NNT = 5
Significant increase in the proportion of patients with a Hyperhidrosis Disease Severity Score of 1-2 at the end of treatment and ≥ 50% reduction in total gravimetric weight of sweat at the end of treatment, intention-to-treat analysis (53.9% vs. 36.4%; AD 17.5%, 95% CI 6.02 to 28.93).
Secondary outcomes
Significant increase in the proportion of patients with a Hyperhidrosis Disease Severity Score of 1-2 at the end of treatment and ≥ 50% reduction in total gravimetric weight of sweat at the end of treatment, per-protocol analysis (54.5% vs. 37.8%; AD 16.8%, 95% CI 4.78 to 28.72).
Significant increase in Hyperhidrosis Disease Severity Score of 1-2 at week 6 (60.3% vs. 47.9%; AD 12.4%, 95% CI 0.86 to 23.99).
Significant increase in ≥ 50% reduction in total gravimetric weight of sweat at week 6 (77.3% vs. 66.4%; AD 10.9%, 95% CI 0.44 to 21.32).
Safety outcomes
No significant difference in serious treatment-emergent adverse events.
Conclusion
In patients with primary axillary hyperhidrosis, sofpironium was superior to vehicle with respect to proportion of patients with a Hyperhidrosis Disease Severity Score of 1-2 at the end of treatment and ≥ 50% reduction in total gravimetric weight of sweat at the end of treatment, intention-to-treat analysis.
Reference
Hiroo Yokozeki, Tomoko Fujimoto, Yoichiro Abe et al. A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis. J Dermatol. 2021 Mar;48(3):279-288.
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