Facial RhytidesPhase 3NCT01189760
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
A Phase 3 study testing onabotulinumtoxinA 24 U, onabotulinumtoxinA 44 U and normal saline in people with Facial 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 and Frown Lines (Facial Rhytides) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Rhytides, Crow's Feet Lines, Glabellar Lines
- What is being tested?
- onabotulinumtoxinA 24 U, onabotulinumtoxinA 44 U and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 917 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Sep 2010to 1 Sep 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 and Frown Lines
- Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK)
Who cannot join
- Current or previous botulinum toxin treatment of any serotype
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
- Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
- Oral retinoid therapy within one year
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 and Frown Lines (Facial Rhytides)
- Conditions
- Facial Rhytides, Crow's Feet Lines, Glabellar Lines
- Being tested
- onabotulinumtoxinA 24 U, onabotulinumtoxinA 44 U, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinA 24 UBiological
Also called BOTOX®, BOTOX® Cosmetic, onabotulinumtoxinA
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.
onabotulinumtoxinA 44 UBiological
Also called BOTOX®, BOTOX® Cosmetic, onabotulinumtoxinA
44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart
normal salineDrug
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.
| Study group | Role | What they receive |
|---|---|---|
| onabotulinumtoxinA 44U | Experimental | 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. Receives: Biological: onabotulinumtoxinA 44 U |
| onabotulinumtoxinA 24U | Other | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. Receives: Biological: onabotulinumtoxinA 24 U; Drug: normal saline |
| placebo (normal saline) | Placebo comparator | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. 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 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 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: 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 Sep 2010
- Primary completion1 Mar 2011
- Study completion1 Sep 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 Facial 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
- 917 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
- NCT01189760
- Sponsor's protocol ID
- 191622-099
- Status last verified
- Apr 2019
- First submitted
- 25 Aug 2010
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Moers-Carpi M, Carruthers J, Fagien S, Lupo M, Delmar H, Jones D, Somogyi C, Lee E, Lei X, MacKinnon S, Davis PG, Yalamanchili R, Campo A, Beddingfield FC 3rd. Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2015 Jan;41(1):102-12. doi: 10.1097/DSS.0000000000000220.
PubMed 25485803
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
- Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
- ClinicalTrials.gov ID
- NCT01189760
- Acronym / sponsor ID
- 191622-099
- Conditions
- Facial Rhytides, Crow's Feet Lines, Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 917 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Mar 2011 (actual)
- Study completion
- 1 Sep 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 and Frown Lines (Facial Rhytides)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| onabotulinumtoxinA 44U | Experimental | Biological: onabotulinumtoxinA 44 U44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| onabotulinumtoxinA 24U | Other | Biological: onabotulinumtoxinA 24 U, Drug: normal saline24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| placebo (normal saline) | Placebo comparator | Drug: normal salineNormal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
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 and Frown Lines
- Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK)
Key exclusion criteria (5 listed)
- Current or previous botulinum toxin treatment of any serotype
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
- Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
- Oral retinoid therapy within one year
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 |
|---|---|---|
| onabotulinumtoxinA 24 UAlso: BOTOX®, BOTOX® Cosmetic, onabotulinumtoxinA24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart. | Biological | onabotulinumtoxinA 24U |
| onabotulinumtoxinA 44 UAlso: BOTOX®, BOTOX® Cosmetic, onabotulinumtoxinA44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart | Biological | onabotulinumtoxinA 44U |
| normal salineNormal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart. | Drug | onabotulinumtoxinA 24U, 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 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 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25485803Moers-Carpi M, Carruthers J, Fagien S, Lupo M, Delmar H, Jones D, Somogyi C, Lee E, Lei X, MacKinnon S, Davis PG, Yalamanchili R, Campo A, Beddingfield FC 3rd. Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2015 Jan;41(1):102-12. doi: 10.1097/DSS.0000000000000220.
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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
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 24 U, onabotulinumtoxinA 44 U and normal saline in people with Facial 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 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 4 sites in United States, Canada, France, Germany. 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 NCT01189760, 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.