Preliminary assessment of the efficacy of a medical device in regulating sweat secretion in the presence of hyperhidrosis and bromhidrosis: an observational study

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.