Axillary hyperhidrosis. Localized hyperhidrosis
Conditions
Interventions
Intervention 1: Botulinum toxin-A injection in each axilla 1.5 ml toxin equal to 250 units at 15 sites in each 1 cm. Intervention 2: Botulinum toxin-A iontophoresis with current generator (Schulze & B
Treatment - Drugs
Botulinum toxin-A injection in each axilla 1.5 ml toxin equal to 250 units at 15 sites in each 1 cm
Botulinum toxin-A iontophoresis with current generator (Schulze & Böhm GmbH, Germany, medisun®) in each axilla 1.5 ml dissolved toxin equal to 250 units in special pads
Sponsors
Tehran University of Medical Siences, Vice Chancellor For Research
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Having the complaint of axillary hyperhidrosis for at least 1 year and the amount of measured sweet secretion is more than 50 mg/min in at least two gravimetery testing 2) Age between 18-50 years 3) both genders 4) Willingness for participation in the study and signing the consent form Exclusion criteria: 1) Pregnant or breast-feeding women 2) Patients with motor neuron diseases such as myastini gravis, Eaton-Lambert syndrome 3) Patients who are taking Aminoglycoside antibiotics and patients who are sensitive to botuilinum toxin 4) Patients with arrhythmia or heart pace-maker
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sweat measurment (Corneometer method). Timepoint: Prior to intervention and at 1week 3, 6, 9, 12, months following intervention. Method of measurement: Sweat measurment by Corneometer.;Sweat measurment (Gravimetry method). Timepoint: Prior to intervention and at 1week 3, 6, 9, 12, months following intervention. Method of measurement: Sweat measurment by Gravimetry.;Degree of patient satisfaction. Timepoint: During the first week and then at 3, 6, 9, and 12 months after intervention. Method of measurement: After thorough follow-up and questioning from patients.;Pain. Timepoint: Prior to intervention and at 1week 3, 6, 9, 12, months following intervention. Method of measurement: Visual Analouge Scale.;Rate of treatment consistency. Timepoint: During the first week and then at 3, 6, 9, and 12 months after intervention. Method of measurement: By the analysis of results obtained from sweat measurement techniques. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: During the first week and then at 3, 6, 9, and 12 months after intervention. Method of measurement: Questioning from patients. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Aliraza Firuz
Center for research and training in skin diseases and leprosy
Outcome results
None listed