Facial RhytidesPhase 3NCT02261493
A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides
A Phase 3 study testing OnabotulinumtoxinA and Normal Saline in people with Facial Rhytides and Glabellar Rhytides, run by Allergan at 24 sites in 4 countries.
Trial summary
This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Rhytides, Glabellar Rhytides
- What is being tested?
- OnabotulinumtoxinA and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 787 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 27 Oct 2014to 20 Apr 2016
- 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 forehead lines, glabellar lines, and crow's feet lines
- Willing to have facial photos taken
Who cannot join
- Prior exposure to botulinum toxin of any serotype for any indication
- Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
- Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
- Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year - Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)
- Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
United States10 sites
The Center for Skin Research
Houston, Texas, 77056
The Petrus Center for Aesthetic
Little Rock, Arkansas, 72205
Westside Aesthetics
Los Angeles, California, 90025
Baumann Cosmetic & Research Institute
Miami, Florida, 33137
The Center For Dermatology Cosmetic and Laser Surgery
Mount Kisco, New York, 10549
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Eye Research Foundation
Newport Beach, California, 92663
Steve Yoelin, MD Medical Associates, Inc.
Newport Beach, California, 92663
Premier Clinical Research
Spokane, Washington, 99202
Saint Louis University
St Louis, Missouri, 63122
Germany6 sites
Rosenpark Research
Darmstadt
Hautzentrum Koeln (Cologne Dermatology)
Köln Nordrhein-Westfalen
Hautok und hautok-cosmetics
München
Praxisgemeinschaft Theatiner46
München
Hautzentrum am Starnberger See GmbH
Starnberg
CentroDerm Study Center
Wuppertal
United Kingdom5 sites
Shakespeare House Health Centre, General Practice
Basingstoke, RG24 9DT
Medizen Clinic
Birmingham, B74 2UG
The Bosham Clinic
Chichester, PO18 8AN
Waverlery Medical Practice
Coatbridge, ML5 3PA
The Gatehouse
Whitegate, CW9 8UW
Belgium3 sites
Aalst Dermatology Clinic
Aalst
UZ Brussel
Jette
Medical Skin Care - Sint-Truiden
Limbourg
About this study
Official title: Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)
This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]).
- Conditions
- Facial Rhytides, Glabellar Rhytides
- 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® Cosmetic, botulinum toxin Type A
OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.
Normal SalineDrug
Placebo (normal saline) injected into the protocol-specified areas on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA Dose A | Experimental | OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. Receives: Biological: OnabotulinumtoxinA |
| OnabotulinumtoxinA Dose B | Experimental | OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. Receives: Biological: OnabotulinumtoxinA |
| Placebo followed by OnabotulinumtoxinA Dose A | Placebo comparator | Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation
The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.
Measured: Baseline, Day 30
Secondary outcomes (6)
Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation
The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of "none" and "mild" are reported.
Measured: Day 30
Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest
The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.
Measured: Baseline, Day 30
Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5
The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks "How satisfied are you with the effect your treatment had on your facial lines?" Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported.
Measured: Day 60
Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points
The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.
Measured: Baseline, Day 30
Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©
The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is "I look older than my actual age because of my facial lines" with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis.
Measured: Baseline, Day 30
Time to Retreatment Eligibility
Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start27 Oct 2014
- Primary completion3 Jun 2015
- Study completion20 Apr 2016
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
- 787 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
- NCT02261493
- Sponsor's protocol ID
- 191622-143
- Other IDs
- 2014-001815-38, 2014
- Status last verified
- Jun 2017
- First submitted
- 3 Oct 2014
- Last updated
- 25 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)
- ClinicalTrials.gov ID
- NCT02261493
- Acronym / sponsor ID
- 191622-143
- Conditions
- Facial Rhytides, Glabellar Rhytides
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 787 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2014 (actual)
- Primary completion
- 3 Jun 2015 (actual)
- Study completion
- 20 Apr 2016 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Posted 25 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA Dose A | Experimental | Biological: OnabotulinumtoxinAOnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| OnabotulinumtoxinA Dose B | Experimental | Biological: OnabotulinumtoxinAOnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. |
| Placebo followed by OnabotulinumtoxinA Dose A | Placebo comparator | Drug: Normal SalinePlacebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas. |
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 forehead lines, glabellar lines, and crow's feet lines
- Willing to have facial photos taken
Key exclusion criteria (7 listed)
- Prior exposure to botulinum toxin of any serotype for any indication
- Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
- Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
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® Cosmetic, botulinum toxin Type AOnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments. | Biological | OnabotulinumtoxinA Dose A, OnabotulinumtoxinA Dose B |
| Normal SalinePlacebo (normal saline) injected into the protocol-specified areas on Day 1. | Drug | Placebo followed by OnabotulinumtoxinA Dose A |
Primary outcome
Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation
Time frame: Baseline, Day 30
The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.
6 secondary outcomes
Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation
Time frame: Day 30
Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest
Time frame: Baseline, Day 30
Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5
Time frame: Day 60
Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points
Time frame: Baseline, Day 30
Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©
Time frame: Baseline, Day 30
Time to Retreatment Eligibility
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
24 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 Facial Rhytides and Glabellar Rhytides, run by Allergan at 24 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 7 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 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Germany, United Kingdom, Belgium. 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 Jul 2017). 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 With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation (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?
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 Jul 2017.