Hyperhidrosis
Conditions
Keywords
botulinum toxim, abobotulinum, hyperhydrosis, injection
Brief summary
The purpose of this study is to describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.
Detailed description
The abobotulinumtoxinA (ABO) will be used in all patients. The ABO will be prepared by adding 4 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial Preinjection patient pictures will be taken showing the technique used for each armpit. Injection technique: 1. Technique 1 The Quadrant technique: 5 vertical lines and 5 horizontal lines will be draw on the hair bearing area of the armpit amounting to 25 injection points being more concentrated on the center. Each injection consists of 5Units of abobotulinum 2. Technique 2 the six injection technique: will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units Follow up will be done at 15 days for post injection pictures with iodine starch test A total of 15 male patients will be recruited. And the injection for each armpit in a given patient is randomized.
Interventions
DRUGbotulinum toxin A
injection in hair bearing area of armpits
Sponsors
St Joseph University, Beirut, Lebanon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
the objective assessment with iodine starch test
Intervention model description
describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Consecutive 15 male patients presenting to our clinic for primary localized hyperhidrosis will be included in this study
Exclusion criteria
* Patient that has received a botulinum injection in the past year Patient that had a liposuction in the armpit or laser for the hair Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome) Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics) Patients with sensitivity to botulinum toxin or human albumin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective iodine startch | 3weeks | Objective assessment will be done using the iodine starch after a 5 min jumping jack on the post injection visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| subjective: patient satisfaction | 3 weeks | Patient satisfaction will be determined by a questionnaire completed at 3 weeks post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow: 1. Very Satisfied 2. Satisfied 3. Dissatisfied 4. Very Dissatisfied. |
| subjective: pain on injection | day 0 | A verbal scale from 1-10 will be addressed for every patient and every armpit |
Countries
Lebanon
Outcome results
None listed