A new observational study indicates that topical 5% sofpironium bromide gel demonstrates early efficacy (<six weeks) in the treatment of primary axillary hyperhidrosis.
The single-centre study was conducted in 80 patients in Japan, where sofpironium bromide gel was approved for this indication in 2020. During the Phase III trial prior to approval, the effects of the treatment were assessed after six weeks of treatment. In the new study published in The Journal of Dermatology, the investigators rated efficacy after two weeks of therapy. They note the study was a single-arm, observational study; and their findings need to be verified in a further study with a placebo arm.
Patients included in the study were 20 years of age or older with a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 at baseline.
Patients were excluded if they had used relevant medications or therapies such as herbal treatments, systemic and topical anticholinergics, oral cholinergic agonists, serotonin agonists, β-blockers, α-adrenergic agonists, dopamine partial agonists, tricyclic antidepressants, aluminum chloride and botulinum toxin within nine months.
According to the researchers, the primary endpoint for the effectiveness of the sofpironium treatment was the change in the proportion of patients with an HDSS score of 1, 2, 3, or 4 during the two-week study period. Of the 80 patients included in the final analysis, the mean age was 33.3 ± 9.4 years and 75 were female. The treatment was applied to the axillae once daily.
By day seven, 55% of the patients had achieved an HDSS score of 1 or 2 The median to achieve an HDSS score of 1 or 2 for two continuous days was six days of treatment No adverse events were reported during the two-week study period.
The researchers report these results suggest that in patients with an HDSS score of 3 or 4, one week of treatment with sofpironium can result in 50% achieving an HDSS score of 1 or 2, which is considered a clinically significant improvement.