Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Wrinkles

Intervention / Treatment
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* Drug: onabotulinumtoxinA
* Drug: JUVÉDERM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botox Cosmetic<br>onabotulinumtoxinA for injection | Drug: onabotulinumtoxinA<br>* 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.<br>* Other names: VISTABEL® (Botulinum toxin type A) for Injection;|
| Active Comparator: JUVÉDERM<br>JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel | Drug: JUVÉDERM<br>* 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.<br>* Other names: JUVÉDERM® Ultra 2 and JUVÉDERM® Ultra 3 Injectable Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 4, 8, 12, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Label, BOTOX, JUVEDERM, Prospective, Randomized, Crossover Study