Glabellar RhytidesPhase 4NCT01814670
Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines
A Phase 4 study testing botulinum toxin Type A in people with Glabellar Rhytides, run by Allergan at 1 site in China.
Trial summary
A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Glabellar Rhytides
- What is being tested?
- botulinum toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2013to 29 Oct 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- moderate or severe frown lines
- facial laser treatment between 4 to 8 weeks prior to Day 1
Who cannot join
- previous use of botulinum toxin for any indication
- diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months
- facial cosmetic procedures within the last 6 Months
- treatment to forehead, brow, nose or midface areas with any filler within the last 12 months
- use of a new topical skin care product within 1 month of the screening
Show all 10Show fewer
- any prior forehead or periorbital surgery or brow lift
- deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity
- any facial skin infection or unhealed skin lesion
- pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.
- Conditions
- Glabellar Rhytides
- Being tested
- botulinum toxin Type A
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®, onabotulinumtoxinA
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin Type A | Experimental | 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1. Receives: Biological: botulinum toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Measured: Day 1, Day 30
Secondary outcomes (4)
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Measured: Day 1, Day 14, Day 90, Day 120
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Measured: Day 1, Day 14, Day 30, Day 90, Day 120
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Measured: Day 1, Day 14, Day 30, Day 90, Day 120
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
The Subject assessed the severity of his/her glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Measured: Day 1, Day 14, Day 30, Day 90, Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study start6 Mar 2013
- Primary completion31 Jul 2014
- Study completion29 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glabellar RhytidesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814670
- Sponsor's protocol ID
- AP-BTXC-12-001
- Status last verified
- Apr 2019
- First submitted
- 18 Mar 2013
- Last updated
- 17 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wu Y, Lu Z, Xie Y, Zhang W, Chen X, Shi Y, Li Q, Halstead M, Rogers JD, Silberberg M. OnabotulinumtoxinA treatment of moderate to severe glabellar lines in Chinese subjects after laser therapy: A prospective, open-label, noncomparative study. J Cosmet Laser Ther. 2018 Oct;20(5):278-286. doi: 10.1080/14764172.2017.1406604. Epub 2018 Mar 2.
PubMed 29498553
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines
- ClinicalTrials.gov ID
- NCT01814670
- Acronym / sponsor ID
- AP-BTXC-12-001
- Conditions
- Glabellar Rhytides
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2013 (actual)
- Primary completion
- 31 Jul 2014 (actual)
- Study completion
- 29 Oct 2014 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Posted 1 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin Type A | Experimental | Biological: botulinum toxin Type A20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- moderate or severe frown lines
- facial laser treatment between 4 to 8 weeks prior to Day 1
Key exclusion criteria (10 listed)
- previous use of botulinum toxin for any indication
- diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months
- facial cosmetic procedures within the last 6 Months
- treatment to forehead, brow, nose or midface areas with any filler within the last 12 months
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®, onabotulinumtoxinA20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1. | Biological | botulinum toxin Type A |
Primary outcome
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
Time frame: Day 1, Day 30
The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
4 secondary outcomes
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
Time frame: Day 1, Day 14, Day 90, Day 120
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
Time frame: Day 1, Day 14, Day 30, Day 90, Day 120
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
Time frame: Day 1, Day 14, Day 30, Day 90, Day 120
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
Time frame: Day 1, Day 14, Day 30, Day 90, Day 120
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29498553Wu Y, Lu Z, Xie Y, Zhang W, Chen X, Shi Y, Li Q, Halstead M, Rogers JD, Silberberg M. OnabotulinumtoxinA treatment of moderate to severe glabellar lines in Chinese subjects after laser therapy: A prospective, open-label, noncomparative study. J Cosmet Laser Ther. 2018 Oct;20(5):278-286. doi: 10.1080/14764172.2017.1406604. Epub 2018 Mar 2.
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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
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 Type A in people with Glabellar Rhytides, run by Allergan at 1 site 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 2 inclusion and 10 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 17 Apr 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 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. 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?
Yes. Results are posted in the registry (first posted 1 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction (time frame: Day 1, Day 30). 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 NCT01814670, 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 17 Apr 2019.