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

NCT ID: NCT01269801

Last Updated: 2014-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-02-29

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

Conditions

Wrinkles

Keywords

BOTOX; JUVEDERM; Prospective; Open Label; Randomized; Crossover Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botox Cosmetic

onabotulinumtoxinA for injection

Group Type: ACTIVE_COMPARATOR

onabotulinumtoxinA

Intervention Type: 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.

JUVÉDERM

JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel

Group Type: ACTIVE_COMPARATOR

JUVÉDERM

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Europe Investigative Sites: VISTABEL® (Botulinum toxin type A) for Injection; EU Investigative Sites: JUVÉDERM® Ultra 2 and JUVÉDERM® Ultra 3 Injectable Gel

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

AboutSkin Dermatology and DermSurgery, PC

INDUSTRY

Sponsor Role: lead

Responsible Party

AboutSkin Dermatology

Joel L. Cohen, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel L Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

AboutSkin Dermatology and DermSurgery, PC

Locations

About Skin Dermatology

Englewood, Colorado, United States

Niagara Falls Dermantology and Skin Care Center

Niagara Falls, Ontario, Canada

University of Toronto

Toronto, Ontario, Canada

Countries

Germany; United States; Canada

Other Identifiers

JUVE_BTX-09-01

Identifier Type: -

Identifier Source: org_study_id