Lateral Canthus RhytidesPhase 3NCT01189747
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines
A Phase 3 study testing onabotulinumtoxinA and normal saline in people with Lateral Canthus Rhytides and Crow's Feet Lines, run by Allergan at 4 sites in 4 countries.
Trial summary
This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Canthus Rhytides, Crow's Feet Lines
- What is being tested?
- onabotulinumtoxinA and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Oct 2010to 1 Jul 2011
- 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
- Have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses OK)
Who cannot join
- Current or previous botulinum toxin treatment of any serotype
- Facial laser or light treatment, microdermabrasion or superficial peels within 3 months
- Oral retinoid therapy within 1 year
- Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).
- Conditions
- Lateral Canthus Rhytides, Crow's Feet Lines
- Being tested
- onabotulinumtoxinA, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinABiological
Also called BOTOX®, BOTOX® Cosmetic
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1
normal salineDrug
Injected into bilateral Crow's Feet Line areas on Day 1
| Study group | Role | What they receive |
|---|---|---|
| onabotulinumtoxinA | Experimental | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1. Receives: Biological: onabotulinumtoxinA |
| placebo (normal saline) | Placebo comparator | 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 Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile
The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at 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: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.
Measured: Baseline, Day 30
Secondary outcomes (8)
Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator's Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines
The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 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
Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile
The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 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: Baseline, Day 30
Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest
The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 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: Baseline, Day 30
Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score
Patients rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.
Measured: Day 30
Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline
Participants were considered to judge themselves 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: Baseline, Day 30
Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: "When I look in the mirror, my facial lines make me look older than I want to look." The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
Measured: Baseline, Day 30
Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: "My facial lines make me look less attractive than I want to look." The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
Measured: Baseline, Day 30
Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30
The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from baseline for FLO-11 Question #8: "My facial lines make me look tired" The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).
Measured: Baseline, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study start1 Oct 2010
- Primary completion1 Apr 2011
- Study completion1 Jul 2011
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
- 446 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
- NCT01189747
- Sponsor's protocol ID
- 191622-098
- Status last verified
- Apr 2019
- First submitted
- 25 Aug 2010
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carruthers A, Bruce S, de Coninck A, Connolly S, Cox SE, Davis PG, Campo A, Lei X, Somogyi C, Lee E, McLean H, Beddingfield F. Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2014 Nov;40(11):1181-90. doi: 10.1097/DSS.0000000000000128.
PubMed 25347451
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines
- ClinicalTrials.gov ID
- NCT01189747
- Acronym / sponsor ID
- 191622-098
- Conditions
- Lateral Canthus Rhytides, Crow's Feet Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 1 Apr 2011 (actual)
- Study completion
- 1 Jul 2011 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Posted 3 Dec 2013
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 botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| onabotulinumtoxinA | Experimental | Biological: onabotulinumtoxinA24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1. |
| placebo (normal saline) | Placebo comparator | Drug: normal salinenormal 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 (2 listed)
- Moderate to severe Crow's Feet Lines
- Have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses OK)
Key exclusion criteria (5 listed)
- Current or previous botulinum toxin treatment of any serotype
- Facial laser or light treatment, microdermabrasion or superficial peels within 3 months
- Oral retinoid therapy within 1 year
- Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
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 |
|---|---|---|
| onabotulinumtoxinAAlso: BOTOX®, BOTOX® Cosmetic24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1 | Biological | onabotulinumtoxinA |
| normal salineInjected into bilateral Crow's Feet Line areas on Day 1 | Drug | placebo (normal saline) |
Primary outcome
Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile
Time frame: Baseline, Day 30
The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at 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: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.
8 secondary outcomes
Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator's Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines
Time frame: Day 30
Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile
Time frame: Baseline, Day 30
Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest
Time frame: Baseline, Day 30
Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score
Time frame: Day 30
Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline
Time frame: Baseline, Day 30
Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
Time frame: Baseline, Day 30
Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
Time frame: Baseline, Day 30
Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30
Time frame: Baseline, Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25347451Carruthers A, Bruce S, de Coninck A, Connolly S, Cox SE, Davis PG, Campo A, Lei X, Somogyi C, Lee E, McLean H, Beddingfield F. Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2014 Nov;40(11):1181-90. doi: 10.1097/DSS.0000000000000128.
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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing onabotulinumtoxinA and normal saline in people with Lateral Canthus Rhytides and Crow's Feet Lines, run by Allergan at 4 sites in 4 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 2 inclusion and 5 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 7 May 2019. 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 United States, Belgium, Canada, United Kingdom. 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 3 Dec 2013). 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 Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile (time frame: Baseline, 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 NCT01189747, 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 7 May 2019.