Botulinum toxin treatment in hyperhidrosis (excessive sweating).

Conditions: Hyperhidrosis-craniofacial, inguinal, palmar, plantar and truncal.
MedDRA version: 17.1Level: PTClassification code 10020642Term: HyperhidrosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2011-003132-30-SE

Lead Sponsor: Svettmottagningen Hidroskliniken, Stockholm

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

The following inclusion criteria must be fulfilled prior to inclusion of the patient in the study:

•Informed consent received from patient
•Hyperhidrosis of the head, trunk, groins/buttocks, hands or feet
•Age > 16 years
•Patients must be previously untreated with Btx A/B
•If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control
• Patients must have DLQI-score = 10 and HDSS-score = 3 to be included in the study
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

If any of the below listed exclusion criteria are fulfilled, the patient must NOT be included in the study:

•Contraindication to Btx
•Use of aminoglycosides, tetracyklines , spectinomycin, lincomycin, polymyxin or muscle relaxants
•Pregnancy or lactation
•Patients unwilling to meet the requirements of the protocol
•

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the clinical effect of Botulinum toxin A and Botulinum toxin B in the treatment of hyperhidrosis of the groins/buttocks, hands and feet (Btx A) and in hyperhidrosis of the face/neck and trunk (Btx B).;Secondary Objective: The secondary objectives are to study:<br>The safety of the Btx A/B treatment.<br>The effect of Btx A/B on sweating<br>The effect of BtxA/B on quality of life with a generic instrument <br>The effect of Btx A/B on anxiety and depressive symptoms <br>Patient global satisfaction with this treatment<br>;Primary end point(s): The primary endpoint is the difference between DLQI-values at baseline and 3+/-1 weeks after injection in the Btx A/B treatment groups when compared to the placebo groups. DLQI is the Dermatology Life Quality Index.;Timepoint(s) of evaluation of this end point: 3+/-1 weeks after administration of Botulinum toxin OR Placebo.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints are to study:<br><br>1. Safety by recording of reported adverse events (AE) by the patient at the clinic visits<br>2. Sweating using gravimetry and the HDSS questionnaire, before and after injections<br>3. EQ-5D before and after injections<br>4. Assessment of anxiety and depressive symptoms before and after injections using the LSAS-SR and MADRS-S, respectively<br>5. Patients´ global assessment of therapy<br>;Timepoint(s) of evaluation of this end point: 1. All through the study period starting with the injection with Botulinum toxin OR Placebo.<br>2-4. Between 3+/-1 weeks after administration of Botulinum toxin OR Placebo.<br>5. At follow-ups (3+/-1 weeks after treatment).