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

NCT01269801 | Completed Phase 4 Results DMC

• 1 other identifier: JUVE_BTX-09-01
• Study Type: interventional
• Target: 156
• Locations: 2 countries
• Sites: 3

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.

Conditions

Wrinkles

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Botox Cosmetic

ACTIVE COMPARATOR

onabotulinumtoxinA for injection

Drug: onabotulinumtoxinA

JUVÉDERM

ACTIVE COMPARATOR

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

Drug: JUVÉDERM

Interventions

onabotulinumtoxinA 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.

Also known as: Europe Investigative Sites:, VISTABEL® (Botulinum toxin type A) for Injection

Botox Cosmetic

JUVÉDERM 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.

Also known as: EU Investigative Sites:, JUVÉDERM® Ultra 2 and JUVÉDERM® Ultra 3 Injectable Gel

JUVÉDERM

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AboutSkin Dermatology and DermSurgery, PC: lead
• Allergan: collaborator

Study Sites (3)

About Skin Dermatology

Englewood, Colorado, 80113, United States

Location

Niagara Falls Dermantology and Skin Care Center

Niagara Falls, Ontario, L2E 7H1, Canada

Location

University of Toronto

Toronto, Ontario, M5R3N8, Canada

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; WW Domain-Containing Oxidoreductase; Juvéderm

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Tumor Suppressor Proteins; Neoplasm Proteins

Results Point of Contact

• Title: Joel L. Cohen, MD
• Organization: AboutSkin

research@aboutskinderm.com

303-756-7546

Study Officials

• Joel L Cohen, MD

  AboutSkin Dermatology and DermSurgery, PC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joel L. Cohen, MD

Study Record Dates

• First Submitted: January 2, 2011
• First Posted: January 4, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: February 1, 2012
• Last Updated: December 16, 2014
• Results First Posted: December 16, 2014

Record last verified: 2014-12

Locations

CA (2); US (1)