Facial RhytidesPhase 3NCT01224015

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 normal saline, onabotulinumtoxinA 44 U and onabotulinumtoxinA 24 U in people with Facial Rhytides and Crow's Feet Lines, run by Allergan at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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) for patients who successfully completed Study 191622-099. 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?: normal saline, onabotulinumtoxinA 44 U and onabotulinumtoxinA 24 U
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 684 participants
Where: 4 sitesin 4 countries
Study dates: May 2011to Feb 2012
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

Successfully completed Study 191622-099

Who cannot join

Known immunization or hypersensitivity to botulinum toxin of any serotype
Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment)
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Anticipated need for surgery or hospitalization during the study

Trial locations and contacts

4 sites in 4 countries.

Country

City, postcode or hospital

4 sites in 4 countries

United States1 site

Study site
Newport Beach, California

Other trials in United States

Canada1 site

Study site
Vancouver, British Columbia

Other trials in Canada

France1 site

Study site
Antibes

Other trials in France

Germany1 site

Study site
Berlin

Other trials in Germany

About this study

Conditions: Facial Rhytides, Crow's Feet Lines, Glabellar Lines
Being tested: normal saline, onabotulinumtoxinA 44 U, onabotulinumtoxinA 24 U

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

normal salineDrug
Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
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 may receive up to 2 treatments during the study.
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 may receive up to 2 treatments during the study.

Study groups in NCT01224015
Study group	Role	What they receive
onabotulinumtoxinA 24U	Other	24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. Receives: Drug: normal saline; Biological: onabotulinumtoxinA 24 U
placebo (normal saline)	Placebo comparator	Normal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. Receives: Drug: normal saline
onabotulinumtoxinA 44U	Experimental	44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. Receives: Biological: onabotulinumtoxinA 44 U

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Feb 2012

First posted19 Oct 2010 (estimated)
Study startMay 2011
Primary completionOct 2011
Study completionFeb 2012

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.
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: 684 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01224015
Sponsor's protocol ID: 191622-104
Other IDs: 2010-021271-83
Status last verified: Feb 2014
First submitted: 18 Oct 2010
Last updated: 25 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Facial Rhytides trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2014. 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: NCT01224015
Acronym / sponsor ID: 191622-104
Conditions: Facial Rhytides, Crow's Feet Lines, Glabellar Lines
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 684 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Oct 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 19 Oct 2010 (estimated)
Results: Posted 25 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
onabotulinumtoxinA 24U	Other	Drug: normal saline, Biological: onabotulinumtoxinA 24 U24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
placebo (normal saline)	Placebo comparator	Drug: normal salineNormal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
onabotulinumtoxinA 44U	Experimental	Biological: onabotulinumtoxinA 44 U44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Successfully completed Study 191622-099

Key exclusion criteria (4 listed)

Known immunization or hypersensitivity to botulinum toxin of any serotype
Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment)
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Anticipated need for surgery or hospitalization during the study

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
normal salineNormal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.	Drug	onabotulinumtoxinA 24U, placebo (normal saline)
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 may receive up to 2 treatments during the study.	Biological	onabotulinumtoxinA 44U
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 may receive up to 2 treatments during the study.	Biological	onabotulinumtoxinA 24U

Primary outcome

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
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.

Results and safety

Results posted to the registry on 25 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
onabotulinumtoxinA 44U	361	347
onabotulinumtoxinA 24U	227	211
Placebo (Normal Saline)	96	83

Primary outcome: 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. Number. Unit: Percentage of participants

Measure	onabotulinumtoxinA 44U n = 349	onabotulinumtoxinA 24U n = 223	Placebo (Normal Saline) n = 95
Value	63.6	56.5	1.1

Population analysed: Participants from the Intent-to-treat population, consisting of all randomized participants with data available for analysis.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
onabotulinumtoxinA 44U	6 of 349 (1.7%)	44 of 349 (12.6%)	Not reported
onabotulinumtoxinA 24U	1 of 223 (0.4%)	23 of 223 (10.3%)	Not reported
Placebo (Normal Saline)	1 of 95 (1.1%)	15 of 95 (15.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Facial Rhytides

Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
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Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
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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 normal saline, onabotulinumtoxinA 44 U and onabotulinumtoxinA 24 U 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 1 inclusion and 4 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 25 Feb 2014. 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 25 Feb 2014). 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 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). 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 NCT01224015.

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 25 Feb 2014.