Glabellar LinesPhase 3NCT00408785
A Study Of BOTOX For The Treatment Of Glabellar Lines
A Phase 3 study testing Botulinum Toxin Type A and sodium chloride in people with Glabellar Lines, run by GlaxoSmithKline at 4 sites in China.
Trial summary
This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- Botulinum Toxin Type A and sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 4 sitesChina
- Study dates
- 1 Nov 2006to 9 May 2007
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment.
Who cannot join
- Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
- Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.
Trial locations and contacts
4 sites in 1 country.
China4 sites
GSK Investigational Site
Beijing, 100034
GSK Investigational Site
Beijing, 100036
GSK Investigational Site
Beijing, 100853
GSK Investigational Site
Shanghai, 200040
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines
This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.
- Conditions
- Glabellar Lines
- Being tested
- Botulinum Toxin Type A, sodium chloride
- Keywords
- Botulinum Toxin Type A, safety, efficacy, glabellar lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg
sodium chlorideDrug
sodium chloride 0.9 mg
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Injection Receives: Drug: Botulinum Toxin Type A |
| B | Placebo comparator | Injection Receives: Drug: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigator's rating of Glabellar line severity at maximum frown
Measured: Day 30 after injection
Secondary outcomes (1)
Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations.
Measured: Day 7, 30, 60, 90, 120 after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study start1 Nov 2006
- Primary completion9 May 2007
- Study completion9 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408785
- Sponsor's protocol ID
- 107457
- Status last verified
- Nov 2011
- First submitted
- 6 Dec 2006
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines
- ClinicalTrials.gov ID
- NCT00408785
- Acronym / sponsor ID
- 107457
- Conditions
- Glabellar Lines
- Keywords
- Botulinum Toxin Type A, safety, efficacy, glabellar lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2006 (actual)
- Primary completion
- 9 May 2007 (actual)
- Study completion
- 9 May 2007 (actual)
- First posted
- 7 Dec 2006 (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 Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Botulinum Toxin Type AInjection |
| B | Placebo comparator | Drug: sodium chlorideInjection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment.
Key exclusion criteria (2 listed)
- Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
- Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.
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 Abotulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg | Drug | A |
| sodium chloridesodium chloride 0.9 mg | Drug | B |
Primary outcome
The investigator's rating of Glabellar line severity at maximum frown
Time frame: Day 30 after injection
1 secondary outcome
Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations.
Time frame: Day 7, 30, 60, 90, 120 after injection
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 31 May 2017.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A and sodium chloride in people with Glabellar Lines, run by GlaxoSmithKline at 4 sites in China.
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 2 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 31 May 2017. 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 China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The investigator's rating of Glabellar line severity at maximum frown (time frame: Day 30 after injection). 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 31 May 2017.