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Hyperhydrosis Treatment Using Botulinum Toxin

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
botulinum toxin A
Sponsored by
St Joseph University, Beirut, Lebanon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring botulinum toxim, abobotulinum, hyperhydrosis, injection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hotel Dieu de France

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Technique 1 The Quadrant technique

Technique 2 the six injection technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

objective iodine startch
Objective assessment will be done using the iodine starch after a 5 min jumping jack on the post injection visit.

Secondary Outcome Measures

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.
subjective: pain on injection
A verbal scale from 1-10 will be addressed for every patient and every armpit

Full Information

First Posted
June 12, 2017
Last Updated
January 20, 2019
Sponsor
St Joseph University, Beirut, Lebanon
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1. Study Identification

Unique Protocol Identification Number
NCT03816046
Brief Title
Hyperhydrosis Treatment Using Botulinum Toxin
Official Title
The Quadrant vs the Six Injection Technique in Primary Focal Hyperhidrosis Using Botulinum Toxin: a Cross-over Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Joseph University, Beirut, Lebanon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
Keywords
botulinum toxim, abobotulinum, hyperhydrosis, injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Masking Description
the objective assessment with iodine starch test
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Technique 1 The Quadrant technique
Arm Type
Experimental
Arm Description
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
Arm Title
Technique 2 the six injection technique
Arm Type
Experimental
Arm Description
Intervention: 6 Botulinum Toxin injections. will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units
Intervention Type
Drug
Intervention Name(s)
botulinum toxin A
Intervention Description
injection in hair bearing area of armpits
Primary Outcome Measure Information:
Title
objective iodine startch
Description
Objective assessment will be done using the iodine starch after a 5 min jumping jack on the post injection visit.
Time Frame
3weeks
Secondary Outcome Measure Information:
Title
subjective: patient satisfaction
Description
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.
Time Frame
3 weeks
Title
subjective: pain on injection
Description
A verbal scale from 1-10 will be addressed for every patient and every armpit
Time Frame
day 0

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hotel Dieu de France
City
Beirut
ZIP/Postal Code
0000
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No

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Hyperhydrosis Treatment Using Botulinum Toxin

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