HyperhidrosisPhase 4NCT00168415
A Study Using Botulinum Toxin Type A in Adolescents With Axillary Hyperhidrosis
A Phase 4 study testing Botulinum Toxin Type A in people with Hyperhidrosis, run by Allergan at 2 sites in 2 countries.
Trial summary
A study using Botulinum Toxin Type A in adolescents with axillary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- 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
- 144 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2005to Jun 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Marked axillary hyperhidrosis
Who cannot join
- Previous use of botulinum toxin for hyperhidrosis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
A study using Botulinum Toxin Type A in adolescents 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 up to 6 times during the study depending on the response to treatment
| 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.
Subject's assessment of the severity of hyperhidrosis using the HDS Scale
Measured: Monthly
Secondary outcomes (1)
Measurement of axillary sweat production
Measured: Week 4, Week 8 and any re-injection 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 startAug 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 144 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
- NCT00168415
- Sponsor's protocol ID
- 191622-075
- Status last verified
- Sep 2008
- First submitted
- 13 Sep 2005
- Last updated
- 29 Sep 2008
- Results posted
- No
Publications
Glaser DA, Pariser DM, Hebert AA, Landells I, Somogyi C, Weng E, Brin MF, Beddingfield F. A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis. Pediatr Dermatol. 2015 Sep-Oct;32(5):609-17. doi: 10.1111/pde.12620. Epub 2015 Jun 8.
PubMed 26059781
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 Adolescents With Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT00168415
- Acronym / sponsor ID
- 191622-075
- Conditions
- Hyperhidrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 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.
A study using Botulinum Toxin Type A in adolescents 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
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 up to 6 times during the study depending on the response to treatment | Biological | 1 |
Primary outcome
Subject's assessment of the severity of hyperhidrosis using the HDS Scale
Time frame: Monthly
1 secondary outcome
Measurement of axillary sweat production
Time frame: Week 4, Week 8 and any re-injection 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.
- Derived from this study: PubMed 26059781Glaser DA, Pariser DM, Hebert AA, Landells I, Somogyi C, Weng E, Brin MF, Beddingfield F. A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis. Pediatr Dermatol. 2015 Sep-Oct;32(5):609-17. doi: 10.1111/pde.12620. Epub 2015 Jun 8.
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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
2 sites in 2 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 2 sites in 2 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 2 sites in United States, Canada. 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?
Subject's assessment of the severity of hyperhidrosis using the HDS Scale (time frame: Monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00168415, which also lists 1 linked publication.
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.