Lateral Canthal LinesPhase 3NCT02195687
BOTOX® in the Treatment of Crow's Feet Lines in China
A Phase 3 study testing botulinum toxin Type A and Normal Saline in people with Lateral Canthal Lines and Crow's Feet Lines, run by Allergan at 1 site in China.
Trial summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Canthal Lines, Crow's Feet Lines
- What is being tested?
- botulinum toxin Type A and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Jun 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Moderate to severe Crow's Feet Lines.
Who cannot join
- Current or previous treatment with botulinum toxin of any serotype for any condition within the last year
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Facial laser or light treatment, microdermabrasion or chemical peels within 3 months
- Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year
- Any medium-depth or deep facial peels within 5 years
- Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent soft tissue fillers, synthetic implants or autologous fat transplant.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).
- Conditions
- Lateral Canthal Lines, Crow's Feet Lines
- Being tested
- botulinum toxin Type A, Normal Saline
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®
botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.
Normal SalineDrug
Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin type A | Experimental | 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1. Receives: Biological: botulinum toxin Type A |
| placebo | Placebo comparator | Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
Measured: Day 30
Secondary outcomes (5)
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A
The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.
Measured: Day 30
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.
Measured: Day 30
Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)
Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.
Measured: Day 30
Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire
Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.
Measured: Baseline, Day 30
Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionJun 2015
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 Lateral Canthal LinesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 417 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
- NCT02195687
- Sponsor's protocol ID
- 191622-113
- Status last verified
- Feb 2016
- First submitted
- 18 Jul 2014
- Last updated
- 14 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wu Y, Li C, Garcia J, Baradaran S. Patient-reported Outcomes in Chinese Subjects Treated with OnabotulinumtoxinA for Crow's Feet Lines. J Clin Aesthet Dermatol. 2021 Oct;14(10):27-31.
PubMed 34976286
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOTOX® in the Treatment of Crow's Feet Lines in China
- ClinicalTrials.gov ID
- NCT02195687
- Acronym / sponsor ID
- 191622-113
- Conditions
- Lateral Canthal Lines, Crow's Feet Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin type A | Experimental | Biological: botulinum toxin Type A24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1. |
| placebo | Placebo comparator | Drug: Normal SalinePlacebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Moderate to severe Crow's Feet Lines.
Key exclusion criteria (6 listed)
- Current or previous treatment with botulinum toxin of any serotype for any condition within the last year
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Facial laser or light treatment, microdermabrasion or chemical peels within 3 months
- Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year
- Any medium-depth or deep facial peels within 5 years
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®botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas. | Biological | botulinum toxin type A |
| Normal SalineNormal Saline (placebo) injected into bilateral Crow's Feet Line areas. | Drug | placebo |
Primary outcome
Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
Time frame: Day 30
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
5 secondary outcomes
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A
Time frame: Day 30
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A
Time frame: Day 30
Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)
Time frame: Day 30
Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire
Time frame: Baseline, Day 30
Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34976286Wu Y, Li C, Garcia J, Baradaran S. Patient-reported Outcomes in Chinese Subjects Treated with OnabotulinumtoxinA for Crow's Feet Lines. J Clin Aesthet Dermatol. 2021 Oct;14(10):27-31.
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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 3 study testing botulinum toxin Type A and Normal Saline in people with Lateral Canthal Lines and Crow's Feet Lines, 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 1 inclusion and 6 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 14 Mar 2016. 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. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2016). 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 Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) (time frame: 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 NCT02195687, 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 14 Mar 2016.