Hyperhydrosis Treatment Using Botulinum Toxin

NCT ID: NCT03816046

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-01-01

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.

Conditions

Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Technique 1 The Quadrant technique

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

Group Type: EXPERIMENTAL

botulinum toxin A

Intervention Type: DRUG

injection in hair bearing area of armpits

Technique 2 the six injection technique

Intervention: 6 Botulinum Toxin injections. will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units

Group Type: EXPERIMENTAL

botulinum toxin A

Intervention Type: DRUG

injection in hair bearing area of armpits

Interventions

botulinum toxin A

injection in hair bearing area of armpits

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

St Joseph University, Beirut, Lebanon

OTHER

Sponsor Role: lead

Responsible Party

samer jabbour

M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hotel Dieu de France

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

usj-05

Identifier Type: -

Identifier Source: org_study_id