Hyperhydrosis Treatment Using Botulinum Toxin

NCT03816046 | Completed Phase 4

• 1 other identifier: usj-05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperhidrosis

Keywords

botulinum toxim; abobotulinum; hyperhydrosis; injection

Outcome Measures

Primary Outcomes (1)

• objective iodine startch

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

  3weeks

Secondary Outcomes (2)

• subjective: patient satisfaction

  3 weeks

• subjective: pain on injection

  day 0

Study Arms (2)

Technique 1 The Quadrant technique

EXPERIMENTAL

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

Technique 2 the six injection technique

EXPERIMENTAL

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

Interventions

botulinum toxin A DRUG

injection in hair bearing area of armpits

Technique 1 The Quadrant technique; Technique 2 the six injection technique

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive 15 male patients presenting to our clinic for primary localized hyperhidrosis will be included in this study

You may not qualify if:

• 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

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead

Study Sites (1)

Hotel Dieu de France

Beirut, 0000, Lebanon

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the objective assessment with iodine starch test
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: January 25, 2019
• Study Start: May 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2019
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)