Essential Axillary HyperhidrosisPhase 4NCT00669474
Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.
A Phase 4 study testing Suction curettage and Treatment with Botox in people with Essential Axillary Hyperhidrosis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Part 1: patients with essential hyperhidrosis are treated one time with suction curettage in both axillae. Part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in one axilla, and at the same time one treatment with BOTOX injections in the other axilla. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Axillary Hyperhidrosis
- What is being tested?
- Suction curettage and Treatment with Botox
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2009to Aug 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years
- Persistent bilateral primary axillary hyperhidrosis
- Hidrosis interferes with daily activities of patient
- Gravimetrically minimal 50 mg spontaneous sweat production in each axilla, measured during 5 minutes in room temperature in calm condition
- signed informed consent
- patient can and shall continue the trial until the end, and will follow the instructions correcly
- women in reproductive period had a pregnancy test
Who cannot join
- Medical condition that can be dangerous by treatment with BOTOX, including myastenia gravis, Lambert-Eaton syndrome, ALS, and each other disease that can interfere with the neuromuscular function
- Secundary hyperhidrosis (for example secundary on hyperthyroid problems, lymfoma, malaria)
- Known allergy against study medication, his components, local anesthesia or iodium
- Use of aminoglycosids, curare-like products, or other products which can interfere with the neuromuscular function during the study
- Use of therapy for hyperhidrosis with Aluminium chlorid during the study
- Infection or skin disease in the area to treat
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- Participation in an other therapeutic study on the same time
- Botuline toxine treatment in the last 4 months
- Women who can or who want to become pregnant
- Women in reproductive period who don't use the appropriate contraception
- Patients in a situation of which the researchers decide it can be dangerous, or can interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Part 1: patients with essential hyperhidrosis are treated one time with suction curettage in both axillae.
Part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in one axilla, and at the same time one treatment with BOTOX injections in the other axilla.
- Conditions
- Essential Axillary Hyperhidrosis
- Being tested
- Suction curettage, Treatment with Botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction curettageProcedure or surgery
Suction curettage
Treatment with BotoxDrug
Treatment with Botox
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Suction curettage Receives: Procedure: Suction curettage |
| 2 | Active comparator | Treatment with Botox Receives: Drug: Treatment with Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiviness and duration of effect of both treatments
Measured: 1 year
Secondary outcomes (1)
Adverse events of both treatments
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Axillary HyperhidrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Katia Ongenae, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669474
- Sponsor's protocol ID
- 2008/219
- Status last verified
- Jun 2015
- First submitted
- 28 Apr 2008
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.
- ClinicalTrials.gov ID
- NCT00669474
- Acronym / sponsor ID
- 2008/219
- Conditions
- Essential Axillary Hyperhidrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study never started
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jun 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Apr 2008 (estimated)
- 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.
Part 1: patients with essential hyperhidrosis are treated one time with suction curettage in both axillae.
Part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in one axilla, and at the same time one treatment with BOTOX injections in the other axilla.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Suction curettageSuction curettage |
| 2 | Active comparator | Drug: Treatment with BotoxTreatment with Botox |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 75 years
- Persistent bilateral primary axillary hyperhidrosis
- Hidrosis interferes with daily activities of patient
- Gravimetrically minimal 50 mg spontaneous sweat production in each axilla, measured during 5 minutes in room temperature in calm condition
- signed informed consent
Key exclusion criteria (11 listed)
- Medical condition that can be dangerous by treatment with BOTOX, including myastenia gravis, Lambert-Eaton syndrome, ALS, and each other disease that can interfere with the neuromuscular function
- Secundary hyperhidrosis (for example secundary on hyperthyroid problems, lymfoma, malaria)
- Known allergy against study medication, his components, local anesthesia or iodium
- Use of aminoglycosids, curare-like products, or other products which can interfere with the neuromuscular function during the study
- Use of therapy for hyperhidrosis with Aluminium chlorid during the study
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 |
|---|---|---|
| Suction curettageSuction curettage | Procedure or surgery | 1 |
| Treatment with BotoxTreatment with Botox | Drug | 2 |
Primary outcome
Effectiviness and duration of effect of both treatments
Time frame: 1 year
1 secondary outcome
Adverse events of both treatments
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study never started). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Related InfoLink provided by the sponsor.
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.
Katia Ongenae, MD, PhD principal investigator
University Hospital, Ghent
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 Suction curettage and Treatment with Botox in people with Essential Axillary Hyperhidrosis, run by University Hospital, Ghent at 1 site in Belgium.
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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 Jun 2015. 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 Belgium. 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 was stopped early (reason given: Study never started). Results are not available in the source record.
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?
Effectiviness and duration of effect of both treatments (time frame: 1 year). 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 4 Jun 2015.