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Preliminary assessment of the efficacy of a medical device in regulating sweat secretion



Abstract

Hyperhidrosis is a dermatologic disorder defined by sweat over-production without thermoregulation need, and it can present at any age, and both males and females are equally affected. Bromhidrosis is a chronic condition characterized by a malodorous body odour. Both conditions are particularly intense and can cause significant social embarrassment and interfere with social life. Treatment of sweating disorders include the application of aluminium chloride, iontophoresis therapy, botulinum therapy, thoracic sympathectomy, and the use of anticholinergic drugs. The aim of this observational study is to evaluate the preliminary effects of the Ipatchmed Zero Sudo in reducing excessive sweating in hyperhidrosis and bromhidrosis disease. The patch is a topical product that is applied to the affected area to regulate the response to excess sweating by the sweat glands of the endocrine system. The mechanism of action consists of the generation of micro-currents through an electrochemical reaction. The device releases a 0.2% saline solution, which is an isotonic solution compared to that generated by the sweat glands. In this way, a “down regulation” of the sweat of the human body is generated by the osmotic effect. The single-arm monocentric investigation has 11 subjects with both hyperhidrosis and bromhidrosis. The measurement was recorded through the Ratics Scale at the end of the treatment. The device proved to be both effective and safe. The use of the Ipatchmed Zero Sudo can regulate sweating and reduce skin lesions. No adverse effects were recorded, thus demonstrating that the medical device is tolerated.


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