Lateral Canthus RhytidesPhase 3NCT01797081
BOTOX® in the Treatment of Crow's Feet Lines in Japan
A Phase 3 study testing botulinum toxin Type A (24 U), botulinum toxin Type A (12 U) and Normal Saline in people with Lateral Canthus Rhytides and Crow's Feet Lines, run by Allergan at 1 site in Japan.
Trial summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides). Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Lateral Canthus Rhytides, Crow's Feet Lines
- What is being tested?
- botulinum toxin Type A (24 U), botulinum toxin Type A (12 U) and Normal Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- 31 Jan 2013to 7 Jul 2014
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Moderate to severe Crow's Feet Lines
Who cannot join
- Current or previous botulinum toxin treatment of any serotype
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
- Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
- Medium-depth or deep facial peels within 5 years
- Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)
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 to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).
- Conditions
- Lateral Canthus Rhytides, Crow's Feet Lines
- Being tested
- botulinum toxin Type A (24 U), botulinum toxin Type A (12 U), Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin Type A (24 U)Biological
Also called BOTOX®
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
botulinum toxin Type A (12 U)Biological
Also called BOTOX®
12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
Normal SalineOther
Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin Type A (24U) | Experimental | 24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. Receives: Biological: botulinum toxin Type A (24 U) |
| Botulinum toxin Type A (12U) | Experimental | 12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. Receives: Biological: botulinum toxin Type A (12 U) |
| Placebo/Botulinum toxin Type A (24U) | Other | Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A). Receives: Biological: botulinum toxin Type A (24 U); Other: Normal Saline |
| Placebo/Botulinum toxin Type A (12U) | Other | Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A). Receives: Biological: botulinum toxin Type A (12 U); Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants 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 patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
Measured: Day 30
Secondary outcomes (3)
Percentage of Participants Achieving a ≥1-Grade Improvement From Baseline on the Investigator's Assessment of the Severity of CFL at Rest Using the FWS-A
The Investigator assessed the severity of the participant's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1-grade improvement from Baseline at Day 30 is reported.
Measured: Day 30
Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines
Participants rated the change in their Crow's Feet Lines using the Subject's Global Assessment of Change in Crow's Feet Lines (SGA-CFL) 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.
Measured: Day 30
Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline
Participants were considered to judge themselves as looking younger if the category change was from "look my current age" at Baseline to "look younger" at Day 30 or from "look older" at Baseline to "look my current age/younger" at Day 30.
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 posted22 Feb 2013 (estimated)
- Study start31 Jan 2013
- Primary completion18 Jul 2013
- Study completion7 Jul 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 Lateral Canthus 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 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
- NCT01797081
- Sponsor's protocol ID
- 191622-114
- Status last verified
- Apr 2019
- First submitted
- 20 Feb 2013
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Harii K, Kawashima M, Furuyama N, Lei X, Hopfinger R, Lee E. OnabotulinumtoxinA (Botox) in the Treatment of Crow's Feet Lines in Japanese Subjects. Aesthetic Plast Surg. 2017 Oct;41(5):1186-1197. doi: 10.1007/s00266-017-0844-9. Epub 2017 Jul 21.
PubMed 28733805
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. 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 Japan
- ClinicalTrials.gov ID
- NCT01797081
- Acronym / sponsor ID
- 191622-114
- Conditions
- Lateral Canthus Rhytides, Crow's Feet Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2013 (actual)
- Primary completion
- 18 Jul 2013 (actual)
- Study completion
- 7 Jul 2014 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 10 Feb 2015
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 to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin Type A (24U) | Experimental | Biological: botulinum toxin Type A (24 U)24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
| Botulinum toxin Type A (12U) | Experimental | Biological: botulinum toxin Type A (12 U)12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. |
| Placebo/Botulinum toxin Type A (24U) | Other | Biological: botulinum toxin Type A (24 U), Other: Normal SalinePlacebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A). |
| Placebo/Botulinum toxin Type A (12U) | Other | Biological: botulinum toxin Type A (12 U), Other: Normal SalinePlacebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A). |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Moderate to severe Crow's Feet Lines
Key exclusion criteria (6 listed)
- Current or previous botulinum toxin treatment of any serotype
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
- Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
- 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 A (24 U)Also: BOTOX®24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment. | Biological | Botulinum toxin Type A (24U), Placebo/Botulinum toxin Type A (24U) |
| botulinum toxin Type A (12 U)Also: BOTOX®12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment. | Biological | Botulinum toxin Type A (12U), Placebo/Botulinum toxin Type A (12U) |
| Normal SalineNormal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment. | Other | Placebo/Botulinum toxin Type A (12U), Placebo/Botulinum toxin Type A (24U) |
Primary outcome
Percentage of Participants 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 patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
3 secondary outcomes
Percentage of Participants Achieving a ≥1-Grade Improvement From Baseline on the Investigator's Assessment of the Severity of CFL at Rest Using the FWS-A
Time frame: Day 30
Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines
Time frame: Day 30
Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline
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 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28733805Harii K, Kawashima M, Furuyama N, Lei X, Hopfinger R, Lee E. OnabotulinumtoxinA (Botox) in the Treatment of Crow's Feet Lines in Japanese Subjects. Aesthetic Plast Surg. 2017 Oct;41(5):1186-1197. doi: 10.1007/s00266-017-0844-9. Epub 2017 Jul 21.
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 (24 U), botulinum toxin Type A (12 U) and Normal Saline in people with Lateral Canthus Rhytides and Crow's Feet Lines, run by Allergan at 1 site in Japan.
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 16 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 Japan. 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 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 10 Feb 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 Participants 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 NCT01797081, 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 16 Apr 2019.