Hyperhidrosis Clinical Trial
Official title:
Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis, a Randomized, Double Blind, Placebo Controlled Study
Hyperhidrosis is defined as excessive sweating and affects about 2.8 % of the population.
It has been shown to have a deleterious effect on the quality of life measured using the
Dermatology Life Quality Index (DLQI) which is one of the most widely used
dermatology-specific quality of life instruments. This is comparable to the effect on quality
of life in patients with severe psoriasis of the skin as well as to nodulocystic acne
patients before treatment with oral isotretinoin.
The clinical effect of Botulinum Toxin (Btx) A has been established in three randomized
controlled trials (RCT) in axillary hyperhidrosis. One RCT has indicated a positive effect in
palmar hyperhidrosis. Although there is increasing evidence that Btx A and B have a similar
effect on hyperhidrosis of other parts of the body (ie hyperhidrosis of the face, trunk,
groin and feet) which is reported in case-reports and open studies there is still a great
need for more controlled studies. This is why we will carry out this randomized,
double-blind, placebo-controlled study to investigate the clinical effect and safety of Btx A
in palmar, plantar and inguinal (groins/buttocks) hyperhidrosis and the clinical effect and
safety of Btx B in craniofacial and truncal hyperhidrosis, respectively. Besides using the
DLQI instrument we will also study Btx A/B to elucidate the impact of this treatment on
quality of life using a generic instrument, the effect on anxiety and depressive symptoms,
sweating, and patients´global assessment of therapy.
n/a
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