Hyperhydrosis Treatment Using Botulinum Toxin

• ClinicalTrials.gov Identifier: NCT03816046
• Recruitment Status: Completed
• First Posted: January 25, 2019
• Last Update Posted: January 25, 2019
• Sponsor: St Joseph University, Beirut, Lebanon
• Information provided by (Responsible Party): samer jabbour, St Joseph University, Beirut, Lebanon

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.

Condition or disease	Intervention/treatment	Phase
Hyperhidrosis	Drug: botulinum toxin A	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: the objective assessment with iodine starch test
• Primary Purpose: Treatment
• Official Title: The Quadrant vs the Six Injection Technique in Primary Focal Hyperhidrosis Using Botulinum Toxin: a Cross-over Clinical Trial.
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: July 1, 2018
• Actual Study Completion Date: January 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: botulinum toxin A; injection in hair bearing area of armpits
Experimental: 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	Drug: botulinum toxin A; injection in hair bearing area of armpits

Outcome Measures

Primary Outcome Measures :

1. objective iodine startch [ Time Frame: 3weeks ]
   Objective assessment will be done using the iodine starch after a 5 min jumping jack on the post injection visit.

Secondary Outcome Measures :

1. subjective: patient satisfaction [ Time Frame: 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.
2. subjective: pain on injection [ Time Frame: day 0 ]
   A verbal scale from 1-10 will be addressed for every patient and every armpit

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Lebanon

Hotel Dieu de France

Beirut, Lebanon, 0000

Sponsors and Collaborators

St Joseph University, Beirut, Lebanon

More Information

• Responsible Party: samer jabbour, M.D, St Joseph University, Beirut, Lebanon
• ClinicalTrials.gov Identifier: NCT03816046
• Other Study ID Numbers: usj-05
• First Posted: January 25, 2019
• Last Update Posted: January 25, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by samer jabbour, St Joseph University, Beirut, Lebanon:

botulinum toxim; abobotulinum; hyperhydrosis; injection

Additional relevant MeSH terms:

Hyperhidrosis; Sweat Gland Diseases; Skin Diseases; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents