WrinklesPhase 4JUVE_BTXNCT01269801
Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds
A Phase 4 study testing onabotulinumtoxinA and JUVÉDERM in people with Wrinkles, run by AboutSkin Dermatology and DermSurgery, PC at 3 sites in 2 countries.
Trial summary
The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC, and BOTOX Cosmetic, work compared to each other and when used together for the cosmetic treatment of age-associated wrinkles and folds of the face. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- onabotulinumtoxinA and JUVÉDERM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2011to Feb 2012
- Phase
- Phase 4
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult females or males, aged 25 to 65 years;
- Subjects must be seeking treatment with either BOTOX® or JUVÉDERM injections;
- Subjects must have one or more moderate to severe hyperfunctional facial lines of the upper face (i.e., glabellar lines, lateral canthal lines (crow's feet) or horizontal forehead lines) or moderate to severe nasolabial folds based on the physician observer assessment (0-3 scale);
- Women must either be of non-childbearing potential (i.e., surgically sterilized or post-menopausal) or if of childbearing potential, must not be pregnant (as documented by a negative urine pregnancy test at the baseline examination) or lactating and must be practicing a medically acceptable method of birth control;
- Subjects must be willing and able to provide written informed consent;
- Subjects must be willing and able to follow the procedures outlined in this protocol.
Who cannot join
- Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control;
- Previous botulinum toxin or semipermanent injectable filler therapy within the past year or any prior history of permanent filler therapy injection;
- Prior cosmetic procedures (i.e., liposuction, etc.) or visible scars that may affect evaluation of response and/or quality of photography;
- Known allergy or sensitivity to any of the study medication or their components;
- Known severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies;
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function;
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- Concurrent use of aminoglycoside antibiotics that interfere with neuromuscular function;
- Subjects with profound atrophy or excessive weakness of the muscles in the target area(s) of BOTOX injection;
- Subjects with an infection at an injection site or systemic infection (in this case, postpone study entry until one week following recovery);
- Concurrent participation in an investigational drug or device study or participation within 30 days of study start;
- Subjects are not to undergo any additional cosmetic procedures during the study period;
- Subjects are not to change use of any facial products up to 6 months prior to enrollment and during study period;
- Subjects with a history of poor cooperation, non-compliance with medical treatment, or unreliability.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Niagara Falls Dermantology and Skin Care Center
Niagara Falls, Ontario, L2E 7H1
University of Toronto
Toronto, Ontario, M5R3N8
About this study
Official title: A Phase IV Prospective, Open Label, Randomized, Crossover Study Evaluating BOTOX Cosmetic for Injection and JUVEDERM Injectable Gel for the Treatment of Moderate to Severe Facial Wrinkles and Folds
The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC, and BOTOX Cosmetic, work compared to each other and when used together for the cosmetic treatment of age-associated wrinkles and folds of the face.
Read the detailed description
- Compounds:
- BOTOX Cosmetic (onabotulinumtoxinA) for Injection
- JUVEDERM Ultra XC and JUVEDERM Ultra Plus XC Injectable Gel
- The objectives of this study are:
- To assess physician assessment of efficacy and incremental benefit following BOTOX Cosmetic and Juvederm for the treatment of moderate to severe facial wrinkles and folds;
- To assess patient perceptions of treatment outcomes and incremental benefit following BOTOX Cosmetic and Juvederm for the treatment of moderate to severe facial wrinkles and folds.
- Investigator and study sites:
- multicenter study
- 5 Sites: 2 in US, 2 in Canada, 1 in EU
- Conditions
- Wrinkles
- Being tested
- onabotulinumtoxinA, JUVÉDERM
- Keywords
- BOTOX, JUVEDERM, Prospective, Open Label, Randomized, Crossover Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinADrug
Also called Europe Investigative Sites:, VISTABEL® (Botulinum toxin type A) for Injection
- Group 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions;
- Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions.
At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.
JUVÉDERMDrug
Also called EU Investigative Sites:, JUVÉDERM® Ultra 2 and JUVÉDERM® Ultra 3 Injectable Gel
Group 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions;
- Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions.
At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.
| Study group | Role | What they receive |
|---|---|---|
| Botox Cosmetic | Active comparator | onabotulinumtoxinA for injection Receives: Drug: onabotulinumtoxinA |
| JUVÉDERM | Active comparator | JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel Receives: Drug: JUVÉDERM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Assessments at Visits 3,5,6+7 (weeks 4,8,12,24) include:
-Physician Global Aesthetic Improvement Scale (PGAIS). Ratings include no change, improved, much improved, very much improved.
Number of subjects with improvement score for the 5 point PGAIS from baseline to Visit 7.
-Objective Observer Global Aesthetic Improvement Scale Number of subjects with improvement score for the from baseline to Visit 7. Ratings include no change, some improvement, definite improvement, substantial improvement, and complete improvement.
Measured: Week 4, 8, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 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 WrinklesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AboutSkin Dermatology and DermSurgery, PC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergan
- Responsible party
- Principal investigator, AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC
- Investigators
- Joel L Cohen, MD, Principal investigator, AboutSkin Dermatology and DermSurgery, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269801
- Sponsor's protocol ID
- JUVE_BTX-09-01
- Acronym
- JUVE_BTX
- Status last verified
- Dec 2014
- First submitted
- 2 Jan 2011
- Last updated
- 16 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Prospective, Open Label, Randomized, Crossover Study Evaluating BOTOX Cosmetic for Injection and JUVEDERM Injectable Gel for the Treatment of Moderate to Severe Facial Wrinkles and Folds
- ClinicalTrials.gov ID
- NCT01269801
- Acronym / sponsor ID
- JUVE_BTX / JUVE_BTX-09-01
- Conditions
- Wrinkles
- Keywords
- BOTOX, JUVEDERM, Prospective, Open Label, Randomized, Crossover Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- AboutSkin Dermatology and DermSurgery, PCIndustry (pharma, biotech, devices)
- Collaborators
- Allergan
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Posted 16 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC, and BOTOX Cosmetic, work compared to each other and when used together for the cosmetic treatment of age-associated wrinkles and folds of the face.
Detailed description
- Compounds:
- BOTOX Cosmetic (onabotulinumtoxinA) for Injection
- JUVEDERM Ultra XC and JUVEDERM Ultra Plus XC Injectable Gel
- The objectives of this study are:
- To assess physician assessment of efficacy and incremental benefit following BOTOX Cosmetic and Juvederm for the treatment of moderate to severe facial wrinkles and folds;
- To assess patient perceptions of treatment outcomes and incremental benefit following BOTOX Cosmetic and Juvederm for the treatment of moderate to severe facial wrinkles and folds.
- Investigator and study sites:
- multicenter study
- 5 Sites: 2 in US, 2 in Canada, 1 in EU
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox Cosmetic | Active comparator | Drug: onabotulinumtoxinAonabotulinumtoxinA for injection |
| JUVÉDERM | Active comparator | Drug: JUVÉDERMJUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult females or males, aged 25 to 65 years;
- Subjects must be seeking treatment with either BOTOX® or JUVÉDERM injections;
- Subjects must have one or more moderate to severe hyperfunctional facial lines of the upper face (i.e., glabellar lines, lateral canthal lines (crow's feet) or horizontal forehead lines) or moderate to severe nasolabial folds based on the physician observer assessment (0-3 scale);
- Women must either be of non-childbearing potential (i.e., surgically sterilized or post-menopausal) or if of childbearing potential, must not be pregnant (as documented by a negative urine pregnancy test at the baseline examination) or lactating and must be practicing a medically acceptable method of birth control;
- Subjects must be willing and able to provide written informed consent;
Key exclusion criteria (13 listed)
- Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control;
- Previous botulinum toxin or semipermanent injectable filler therapy within the past year or any prior history of permanent filler therapy injection;
- Prior cosmetic procedures (i.e., liposuction, etc.) or visible scars that may affect evaluation of response and/or quality of photography;
- Known allergy or sensitivity to any of the study medication or their components;
- Known severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies;
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: Europe Investigative Sites:, VISTABEL® (Botulinum toxin type A) for Injection* Group 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions; * Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions. At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment. | Drug | Botox Cosmetic |
| JUVÉDERMAlso: EU Investigative Sites:, JUVÉDERM® Ultra 2 and JUVÉDERM® Ultra 3 Injectable GelGroup 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions; • Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions. At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment. | Drug | JUVÉDERM |
Primary outcome
Efficacy
Time frame: Week 4, 8, 12, 24
Assessments at Visits 3,5,6+7 (weeks 4,8,12,24) include: -Physician Global Aesthetic Improvement Scale (PGAIS). Ratings include no change, improved, much improved, very much improved. Number of subjects with improvement score for the 5 point PGAIS from baseline to Visit 7. -Objective Observer Global Aesthetic Improvement Scale Number of subjects with improvement score for the from baseline to Visit 7. Ratings include no change, some improvement, definite improvement, substantial improvement, and complete improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joel L Cohen, MD principal investigator
AboutSkin Dermatology and DermSurgery, PC
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing onabotulinumtoxinA and JUVÉDERM in people with Wrinkles, run by AboutSkin Dermatology and DermSurgery, PC at 3 sites in 2 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 6 inclusion and 13 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 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 16 Dec 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?
Efficacy (time frame: Week 4, 8, 12, 24). 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 16 Dec 2014.