Hyperhydrosis Treatment Using Botulinum Toxin

Study Overview
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Brief Summary
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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
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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: 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 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.

Official Title
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The Quadrant vs the Six Injection Technique in Primary Focal Hyperhidrosis Using Botulinum Toxin: a Cross-over Clinical Trial.

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Drug: botulinum toxin A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technique 1 The Quadrant technique<br>Intervention: 25 Botulinum Toxin injections. 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 | Drug: botulinum toxin A<br>* injection in hair bearing area of armpits<br>|
| Experimental: Technique 2 the six injection technique<br>Intervention: 6 Botulinum Toxin injections. will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units | Drug: botulinum toxin A<br>* injection in hair bearing area of armpits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective iodine startch | Objective assessment will be done using the iodine starch after a 5 min jumping jack on the post injection visit. | 3weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective: patient satisfaction | 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: Very Satisfied Satisfied Dissatisfied Very Dissatisfied. | 3 weeks | 
| subjective: pain on injection | A verbal scale from 1-10 will be addressed for every patient and every armpit | day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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botulinum toxim, abobotulinum, hyperhydrosis, injection