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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
Compounds:
The objectives of this study are:
Investigator and study sites:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox Cosmetic | Active Comparator | onabotulinumtoxinA for injection |
|
| JUVÉDERM | Active Comparator | JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Drug |
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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel L Cohen, MD | AboutSkin Dermatology and DermSurgery, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| About Skin Dermatology | Englewood | Colorado | 80113 | United States | ||
| Niagara Falls Dermantology and Skin Care Center |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis stratified by treatment group (per sequence).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis is based on the randomization group to account for the order in which the products were administered. | Posted | Number | participantes rated improved and higher | Week 4, 8, 12, 24 |
|
Week 4, 8, 12, 24
Adverse Events assessed based on treatment received before the adverse event onset.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death due to hypertensive cardiovascular disease | Vascular disorders | Non-systematic Assessment | Subject died 2 months after last study visit, approximately 1.5 months after last juvederm injection. Investigator assessed as not related to study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| (Contusion) Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel L. Cohen, MD | AboutSkin | 303-756-7546 | research@aboutskinderm.com |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000074584 | WW Domain-Containing Oxidoreductase |
| C527044 | Juvéderm |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
| JUVÉDERM | Drug | 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. |
|
|
| Niagara Falls |
| Ontario |
| L2E 7H1 |
| Canada |
| University of Toronto | Toronto | Ontario | M5R3N8 | Canada |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 1 |
| 154 |
| 8 |
| 154 |
| EG001 | 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. | 0 | 152 | 19 | 152 |
|
| Facial Paresis | Nervous system disorders | Non-systematic Assessment |
|
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |