- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01269801
Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds (JUVE_BTX)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ontario
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Niagara Falls, Ontario, Canada, L2E 7H1
- Niagara Falls Dermantology and Skin Care Center
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Toronto, Ontario, Canada, M5R3N8
- University of Toronto
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Colorado
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Englewood, Colorado, United States, 80113
- About Skin Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Botox Cosmetic
onabotulinumtoxinA for injection
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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.
Other Names:
|
Active Comparator: JUVÉDERM
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: Week 4, 8, 12, 24
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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. |
Week 4, 8, 12, 24
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joel L Cohen, MD, AboutSkin Dermatology and DermSurgery, PC
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JUVE_BTX-09-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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