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β0ToxinA® as a valuable therapy for the treatment of hyperhidrosis

Hyperhidrosis may have negative effects on the sufferers' quality of life, often causing psychological distress affecting both private and professional life (from embarassment, to withdrawal, to real psychoses – avoiding to shake hands, have physical contacts with people, choose some careers, etc.).

Such phenomenon can be generalized but is more often local, commonly affecting the armpits (axillary hyperhidrosis), the palms of the hands (palmar hyperhidrosis), the soles of the feet (plantar hyperhidrosis), and the face and scalp (facial hyperhidrosis).

Hyperhidrosis can be secondary, that is caused by an underlying condition - endocrine disorders, such as hyperthyroidism; menopause; obesity; psychiatric disorders; systemic malignant disease. Yet in this case it causes excess sweating of the entire body. Or, more commonly, primary. Causes of primary hyperhidrosis include genetic, metabolic, hormonal or idiopathic pathologies. It often starts during childhood or early adolescence, worsens during puberty, and then persists throughout the person's life. It is triggered by even minor stimuli and is made worse, among others, by anxiety, and some weather conditions (heat, humidity).

news1 corpoFor decades, attempts at countering excessive sweating through several methods have been made, the most common being topical treatments with antiperspirants (aluminium salts, or other agents), anti-anxiety medications, beta blockers, anti-cholinergic s, iontophoresis, lasertherapy, radiotherapy, low intensity electric current.

Some alternative treatments have been used as well, such as acupuncture, biofeedback,
hypnosis, psychotherapy. Most of these have proved to have some effect only on mild hyperhidrosis. The only permanent solution is surgery: endoscopic thoracic sympathectomy (ETS) or surgical resections of the sweat glands by liposuction. Yet many people do not want to undergo such an invasive treatment.

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An effective alternative is treatment with β0ToxinA®, which acts by inhibiting the release of acetylcholine at the presynaptic membrane of cholinergic neurones, thus discouraging sweat production.

Randomized controlled studies conducted in Europe and the USA demonstrate that chemodenervation of sweat glands with injectable Botulinum toxin type, results in fast and substantial reductions in axillary sweating, as quantified by gravimetric measurement of sweat production. The use of Botulinum toxin type A for primary axillary hyperhidrosis is by now well established. It was approved in the USA by the FDA a few years ago, and in June 2003 by the European Commitee, following EMEA (European Agency for the Evaluation of Medicinal Products) evidence. But success has been achieved also in palmar, pedal, and facial hyperhidrosis.

Based on the clinical evidence from published trials, side effects are minor and rare, the most common one being some discomfort at the injection sites during and after treatment. In such case, a local anaesthetic can be used. Furthermore, some bruising can be left, and some occasional transitory muscle weakness, almost exclusively when the palms are treated.

As there can be considerable variation from patient to patient in the area of excessive sweating, mapping it is very important. First of all, a Minor's iodine-starch test should be performed, which makes direct visualization of the area possible. The area is first cleaned and dried thoroughly, then it is painted with an iodine solution (2 g of iodine in 10 ml of almond or castor oil and 90 ml of alcohol) or Lugol solution (2 g of iodine, 4 g of potassium iodide, in distilled water for a total of 100 g). Once dry, the area is dusted with fine (potato or rice) starch powder, which reacts with sweat by turning dark blue-purple, and making the hyperhidrotic areas easily discernible. Such areas are then marked with a surgical pen.

news1 manoptnews1 piedeptAs a β0ToxinA® injection is effective in a zone of 2 cm in diameter, the recommended injection technique is that of dividing the area to be treated into 1.5-2 cm2 squares. Then an injection should be slowly and carefully administered at the centre of each square intradermally as near the surface as possible (2-3 mm deep).
On the basis of the results in clinical studies, the recommended dose is a total of 50 U per each axilla, hand, or foot.

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It is recommended that the lowest effective dose be used in order to prevent the risk of side effects or antibody formation.
It is also advisable to observe the patient for some 20 minutes after treatment.

From clinical experience, the mean duration of effect is approximately 6 months, although in some patients the relief of symptoms lasts 12 or even 18 months. In any case, the injection interval seems to be consistent for each patient.
In case excessive sweating should return before 4 months from the latest treatment, patients should be encouraged to use a topical preparation as retreatment is not recommended within 16 weeks. Trials on patients using β0ToxinA® treatment for years to treat hyperhidrosis showed that effectiveness is constant in time and the formation of antibodies is not a concern.

In summary, β0ToxinA® can be considered an effective, long-lasting, and safe treatment for primary hyperhidrosis.

References:

  • Bushara K., Botulinum toxin and rhinorrhea, Otolaryngol Head Neck Surg 1996; 114(3): 507, and The Laryngoscope 1999, 109: 1344-134
  • Glogau RG., Botulinum A neurotoxin for axillary hyperhidrosis, Dermatol Surg 1998; 24: 817-819
  • Grimalt R., et al., Multi-injection plate for botulinum toxin application in the treatment of axillary hyperhidrosis, Dermatol Surg 2001 June; 27(6): 543-544
  • Kreyden OP, Schmid-Grendelmeier P, Burg G., Idiopathic localized unilateral hyperhidrosis: case report of successful treatment withbotulinum toxin type A and review of the literature. Arch Dermatol 2001; 137: 1622-1625
  • Odderson IR., Hyperhidrosis treated by botulinum A exotoxin. Dermatol Surg 1998; 24: 1237-1241
  • Swartling C., Botulinum Toxin in the Treatment of Focal Hyper-hidrosis and Dyshidrotic Hand Dermatitis. Acta Universitatis Upsaliensis 2002 Thesis

To learn more about this condition, you can visit the International Hyperhidrosis Society websites: http://www.ihhs.net/English/
http://www.hidrosiscure.com/international-hyperhidrosis-society.htm

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