HyperhidrosisPhase 4NCT03816046
Hyperhydrosis Treatment Using Botulinum Toxin
A Phase 4 study testing botulinum toxin A in people with Hyperhidrosis, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- botulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteLebanon
- Study dates
- 1 May 2018to 1 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consecutive 15 male patients presenting to our clinic for primary localized hyperhidrosis will be included in this study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Quadrant vs the Six Injection Technique in Primary Focal Hyperhidrosis Using Botulinum Toxin: a Cross-over Clinical Trial.
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.
Read the 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.
- Conditions
- Hyperhidrosis
- Being tested
- botulinum toxin A
- Keywords
- botulinum toxim, abobotulinum, hyperhydrosis, injection
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin ADrug
injection in hair bearing area of armpits
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective iodine startch
Objective assessment will be done using the iodine starch after a 5 min jumping jack on the post injection visit.
Measured: 3weeks
Secondary outcomes (2)
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.
Measured: 3 weeks
subjective: pain on injection
A verbal scale from 1-10 will be addressed for every patient and every armpit
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 May 2018
- Primary completion1 Jul 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samer jabbour, St Joseph University, Beirut, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816046
- Sponsor's protocol ID
- usj-05
- Status last verified
- Jan 2019
- First submitted
- 12 Jun 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quadrant vs the Six Injection Technique in Primary Focal Hyperhidrosis Using Botulinum Toxin: a Cross-over Clinical Trial.
- ClinicalTrials.gov ID
- NCT03816046
- Acronym / sponsor ID
- usj-05
- Conditions
- Hyperhidrosis
- Keywords
- botulinum toxim, abobotulinum, hyperhydrosis, injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Technique 1 The Quadrant technique | Experimental | Drug: botulinum toxin AIntervention: 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 |
| Technique 2 the six injection technique | Experimental | Drug: botulinum toxin AIntervention: 6 Botulinum Toxin injections. will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive 15 male patients presenting to our clinic for primary localized hyperhidrosis will be included in this study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin Ainjection in hair bearing area of armpits | Drug | Technique 1 The Quadrant technique, Technique 2 the six injection technique |
Primary outcome
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.
2 secondary outcomes
subjective: patient satisfaction
Time frame: 3 weeks
subjective: pain on injection
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing botulinum toxin A in people with Hyperhidrosis, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective iodine startch (time frame: 3weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.