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

Wrinkles Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wrinkles

• NCT number: NCT01269801
• Study type: Interventional
• Source: AboutSkin Dermatology and DermSurgery, PC
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Completion date: February 2012