Wrinkles
Conditions
Keywords
BOTOX, JUVEDERM, Prospective, Open Label, Randomized, Crossover Study
Brief 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.
Detailed description
1. Compounds: 1. BOTOX Cosmetic (onabotulinumtoxinA) for Injection 2. JUVEDERM Ultra XC and JUVEDERM Ultra Plus XC Injectable Gel 2. The objectives of this study are: 1. 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; 2. 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. 3. Investigator and study sites: 1. multicenter study 2. 5 Sites: 2 in US, 2 in Canada, 1 in EU
Interventions
DRUGonabotulinumtoxinA
* 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.
DRUGJUVÉDERM
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.
Sponsors
Allergan
AboutSkin Dermatology and DermSurgery, PC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 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. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Subjects were randomized to two groups: Juvederm first, then Botox (Juvederm group) or Botox first, then Juvederm (Botox group). For the Juvederm group, Day 1 involved juvederm treatment. Week 4 involved botox administration. For the Botox group, Day 1 involved botox treatment. Week 4 involved juvederm administration.
Participants by arm
| Arm | Count |
|---|---|
| Botox Cosmetic Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment. | 80 |
| JUVÉDERM JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment. | 74 |
| Total | 154 |
Baseline characteristics
| Characteristic | JUVÉDERM | Total | Botox Cosmetic |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 154 Participants | 80 Participants |
| Age, Continuous | 51.12 years STANDARD_DEVIATION 7.78 | 50.54 years STANDARD_DEVIATION 7.6 | 49.83 years STANDARD_DEVIATION 7.42 |
| Sex: Female, Male Female | 66 Participants | 142 Participants | 76 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 154 | 19 / 152 |
| serious Total, serious adverse events | 1 / 154 | 0 / 152 |
Outcome results
Primary
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.
Time frame: Week 4, 8, 12, 24
Population: Analysis is based on the randomization group to account for the order in which the products were administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botox Cosmetic | Efficacy | Objective Observer global assessment Week 8 | 78 participantes rated improved and higher |
| Botox Cosmetic | Efficacy | Objective Observer global assessment Week 12 | 77 participantes rated improved and higher |
| Botox Cosmetic | Efficacy | PGAIS Week 8 | 78 participantes rated improved and higher |
| Botox Cosmetic | Efficacy | Objective Observer global assessment Week 24 | 73 participantes rated improved and higher |
| Botox Cosmetic | Efficacy | PGAIS Week 24 | 77 participantes rated improved and higher |
| Botox Cosmetic | Efficacy | PGAIS Week 4 | 75 participantes rated improved and higher |
| Botox Cosmetic | Efficacy | Objective Observer global assessment Week 4 | 72 participantes rated improved and higher |
| Botox Cosmetic | Efficacy | PGAIS Week 12 | 77 participantes rated improved and higher |
| JUVÉDERM | Efficacy | Objective Observer global assessment Week 4 | 74 participantes rated improved and higher |
| JUVÉDERM | Efficacy | PGAIS Week 4 | 74 participantes rated improved and higher |
| JUVÉDERM | Efficacy | PGAIS Week 24 | 74 participantes rated improved and higher |
| JUVÉDERM | Efficacy | Objective Observer global assessment Week 24 | 72 participantes rated improved and higher |
| JUVÉDERM | Efficacy | PGAIS Week 12 | 74 participantes rated improved and higher |
| JUVÉDERM | Efficacy | PGAIS Week 8 | 73 participantes rated improved and higher |
| JUVÉDERM | Efficacy | Objective Observer global assessment Week 8 | 73 participantes rated improved and higher |
| JUVÉDERM | Efficacy | Objective Observer global assessment Week 12 | 74 participantes rated improved and higher |