Hyperhidrosis-craniofacial, inguinal, palmar, plantar and truncal. MedDRA version: 17.1 Level: PT Classification code 10020642 Term: Hyperhidrosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Botox
Pharmaceutical Form: Powder for solution for injection
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equal
P
Sponsors
Svettmottagningen Hidroskliniken, Stockholm
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 •
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: The safety of the Btx A/B treatment. The effect of Btx A/B on sweating The effect of BtxA/B on quality of life with a generic instrument The effect of Btx A/B on anxiety and depressive symptoms Patient global satisfaction with this treatment ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are to study: 1. Safety by recording of reported adverse events (AE) by the patient at the clinic visits 2. Sweating using gravimetry and the HDSS questionnaire, before and after injections 3. EQ-5D before and after injections 4. Assessment of anxiety and depressive symptoms before and after injections using the LSAS-SR and MADRS-S, respectively 5. Patients´ global assessment of therapy ;Timepoint(s) of evaluation of this end point: 1. All through the study period starting with the injection with Botulinum toxin OR Placebo. 2-4. Between 3+/-1 weeks after administration of Botulinum toxin OR Placebo. 5. At follow-ups (3+/-1 weeks after treatment). | — |
Countries
Sweden
Contacts
Public ContactClinical Trials Information
Svettmottagningen Hidroskliniken, Stockholm
Outcome results
None listed