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

Wrinkles Clinical Trial

— JUVE_BTX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269801
• Other study ID #: JUVE_BTX-09-01
• Status: Completed
• Phase: Phase 4
• First received: January 2, 2011
• Last updated: December 12, 2014
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2014
• Source: AboutSkin Dermatology and DermSurgery, PC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Ethics Review CommitteeGermany: Ethics Commission
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: February 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Wrinkles

Intervention

Drug:
• onabotulinumtoxinA
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.
• JUVÉDERM
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.

Locations

Country	Name	City	State
Canada	Niagara Falls Dermantology and Skin Care Center	Niagara Falls	Ontario
Canada	University of Toronto	Toronto	Ontario
United States	About Skin Dermatology	Englewood	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
AboutSkin Dermatology and DermSurgery, PC	Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 4, 8, 12, 24	No