Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01269801
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2011-01-02
Brief Title:
Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds
Sponsor:
AboutSkin Dermatology and DermSurgery PC
Organization:
AboutSkin Dermatology and DermSurgery PC
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JUVE_BTX
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None