Hyperhydrosis Treatment Using Botulinum Toxin

Phase 4

Completed

• Conditions: Hyperhidrosis
• Interventions: Drug: botulinum toxin A

• Registration Number: NCT03816046
• Lead Sponsor: St Joseph University, Beirut, Lebanon

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.

Study Timeline

• Study First Submitted: 2017-06-12
• Study Start: 2018-05-01
• Primary Completion: 2018-07-01
• Status Verified: 2019-01
• Study Completion: 2019-01-01
• Study First Submitted QC: 2019-01-20
• Last Update Submitted: 2019-01-20
• Study First Posted: 2019-01-25
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Technique 2 the six injection technique	botulinum toxin A	Intervention: 6 Botulinum Toxin injections. will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units
Technique 1 The Quadrant technique	botulinum toxin A	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hotel Dieu de France; 🇱🇧 Beirut, Lebanon