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  • Sofpironium may reduce...

Sofpironium may reduce disease severity in primary axillary hyperhidrosis: Study

Written By : Medha Baranwal |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2022-05-15T23:30:29+05:30  |  Updated On 15 May 2022 11:30 PM IST
Sofpironium may reduce disease severity in primary axillary hyperhidrosis: Study
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Japan: Following 1-week treatment with 5% sofpironium bromide gel for patients with a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 resulted in a clinically significant improvement, says a recent study in the Journal of Dermatology.

According to the study, after 1-week treatment with sofpironium, approximately 50% of the patients achieved an HDSS score of 1 or 2, which implies a clinically significant improvement for the patients.

5% sofpironium bromide (ECCLOCK) gel (hereinafter referred to as sofpironium) was approved in Japan in 2020 for the topical treatment of primary axillary hyperhidrosis. A phase III study of sofpironium showed the safety and efficacy of sofpironium; however, no study has investigated its early efficacy at <6 weeks after starting treatment.

To assess the earlier effectiveness of sofpironium, Tomoko Fujimoto, Ikebukuro Nishiguchi Fukurou Dermatology Clinic, Tokyo, Japan, and colleagues conducted a 2-week, single-center, exploratory, prospective, observational study in Japanese patients with primary axillary hyperhidrosis.

Patients aged ≥20 years and satisfying with an HDSS score of 3 or 4 at baseline were eligible for the study. A change in the proportion of patients with an HDSS score of 1, 2, 3, or 4 during the 2-week study period was the primary endpoint. There were more women than men (93.8% vs. 6.3%) in 80 patients included in the full analysis set (FAS), and the mean age (±standard deviation [SD]) was 33.3 ± 9.4 years.

Salient findings of the study include:

  • In the FAS, the proportion of patients with a HDSS score of 1 or 2 was 55.0% on day 7, and statistically significant changes were observed after day 3 compared to baseline.
  • Mean HDSS scores (±SD) were significantly decreased from the baseline value of 3.5 ± 0.5 to 2.4 ± 0.9 on day 7.
  • The median period for sofpironium treatment to achieve an HDSS score of 1 or 2 for a continuous 2 days was 6 days.
  • Safety was evaluated in 92 patients in the safety analysis set, and no adverse events were reported during the study period of 2 weeks.

To conclude, "a 2-week prospective observational study of sofpironium in Japanese patients with primary axillary hyperhidrosis indicates that after 1-week treatment with sofpironium for patients with a HDSS score of 3 or 4, about 50% of the patients can achieve a HDSS score of 1 or 2, which is a clinically significant improvement for the patients."

Reference:

Fujimoto T, Okatsu H, Miyama H. Two-week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis. J Dermatol. 2022 Apr 8. doi: 10.1111/1346-8138.16384. Epub ahead of print. PMID: 35394087.


Journal of Dermatologyhyperhidrosissofpironium
Source : Journal of Dermatology
Medha Baranwal
Medha Baranwal

    MSc. Biotechnology

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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