Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds
Condition: Wrinkles
Intervention: onabotulinumtoxinA; JUVÉDERM
Intervention description: 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.; 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 MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BOTOX; JUVEDERM; Prospective; Open Label; Randomized; Crossover Study

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.
    

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.