HyperhidrosisPhase 4NCT00168480
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
A Phase 4 study testing Botulinum Toxin Type A in people with Hyperhidrosis, run by Allergan at 4 sites in 4 countries.
Trial summary
This is a three year open-label study in subjects with axillary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Botulinum Toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Nov 2003to Apr 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Marked axillary hyperhidrosis
Who cannot join
- Previous use of botulinum toxin for hyperhidrosis
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
This is a three year open-label study in subjects with axillary hyperhidrosis.
- Conditions
- Hyperhidrosis
- Being tested
- Botulinum Toxin Type A
- 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 Type ABiological
Also called BOTOX®
100 U, repeated treatments at > 4 month intervals up to Month 32, over a 36-month study period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Botulinum Toxin Type A Receives: Biological: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of axillary sweat production
Measured: Every 4 Months
Secondary outcomes (1)
Patient reported health outcome measures
Measured: 1 Month Post-Treatment Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionApr 2007
- Study completionApr 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168480
- Sponsor's protocol ID
- 191622-513
- Status last verified
- Sep 2008
- First submitted
- 13 Sep 2005
- Last updated
- 29 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT00168480
- Acronym / sponsor ID
- 191622-513
- Conditions
- Hyperhidrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Sep 2005 (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.
This is a three year open-label study in subjects with axillary hyperhidrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Botulinum Toxin Type ABotulinum Toxin Type A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Marked axillary hyperhidrosis
Key exclusion criteria (1 listed)
- Previous use of botulinum toxin for hyperhidrosis
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 Type AAlso: BOTOX®100 U, repeated treatments at > 4 month intervals up to Month 32, over a 36-month study period | Biological | 1 |
Primary outcome
Assessment of axillary sweat production
Time frame: Every 4 Months
1 secondary outcome
Patient reported health outcome measures
Time frame: 1 Month Post-Treatment Visit
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 29 Sep 2008.
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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.
Medical Director study director
Allergan
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A in people with Hyperhidrosis, run by Allergan at 4 sites in 4 countries.
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 1 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 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, Sweden, United Kingdom. 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?
Assessment of axillary sweat production (time frame: Every 4 Months). 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 29 Sep 2008.