Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds
| Status: | Archived |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2011 |
| End Date: | January 2012 |
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.
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
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