Clinical Trial: Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis, a Randomized, Double Blind, Placebo Controlled Study

Brief Summary:

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.


Detailed Summary:
Sponsor: Carl Swartling

Current Primary Outcome: DLQI (Dermatology Life Quality Index) [ Time Frame: 3±1 weeks after treatment ]

The primary endpoint is scores on DLQI-values at follow-up in the Btx A/B treatment groups when compared to the placebo groups.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • AE (Adverse Events) [ Time Frame: Up to 12 weeks ]
    Safety by recording of reported adverse events (AE) by the patient at the clinic visits
  • Gravimetry [ Time Frame: Before treatment and 3±1 weeks after treatment ]
    The amount of sweat is measured gravimetrically.
  • HDSS (Hyperhidrosis Disease Severity Scale) [ Time Frame: Before treatment and 3±1 weeks after treatment ]
  • Health outcome (EQ-5D) [ Time Frame: Before treatment and 3±1 weeks after treatment ]
  • LSAS-SR (Liebowitz Social Anxiety Scale-Self Report) [ Time Frame: Before treatment and 3±1 weeks after treatment ]
  • MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report) [ Time Frame: Before treatment and 3±1 weeks after treatment ]
  • Global Assessment of Therapy [ Time Frame: 3±1 weeks after treatment ]
    The patient will be asked at the follow-up visit (3±1 weeks after treatment) to give his/her subjective opinion and rate the effect of the treatment using a scale ranging from 1-5.
  • DLQI (Dermatology Life Quality Index) [ Time Frame: Before treatment ]


Original Secondary Outcome: Same as current

Information By: Hidrosis Clinic, Stockholm, Sweden

Dates:
Date Received: August 16, 2013
Date Started: September 2013
Date Completion: October 2017
Last Updated: August 16, 2016
Last Verified: August 2016