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Trial record 12 of 166 for:    "Sweat Gland Disease"

Hyperhydrosis Treatment Using Botulinum Toxin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03816046
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
samer jabbour, 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.

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.


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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

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




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



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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816046


Locations
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Lebanon
Hotel Dieu de France
Beirut, Lebanon, 0000
Sponsors and Collaborators
St Joseph University, Beirut, Lebanon

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Responsible Party: samer jabbour, M.D, St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier: NCT03816046     History of Changes
Other Study ID Numbers: usj-05
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Sweat Gland Diseases
Hyperhidrosis
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