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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC
ClinicalTrials.gov Identifier:
NCT01269801
First received: January 2, 2011
Last updated: July 11, 2013
Last verified: July 2013

January 2, 2011
July 11, 2013
January 2011
September 2011   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: Efficacy assessments at Visit 3 (4 weeks) and Visits 5, 6 and 7 (8, 12 and 24 weeks) ] [ Designated as safety issue: No ]

Assessments at Visits 3,5,6+7 include:

  • Physician Global Aesthetic Improvement Scale (GAIS)
  • Objective Observer Global Assessment of Improvement

Secondary efficacy endpoints will include:

  • Patient Global Assessment of Improvement
  • Facial Line Outcomes (FLO-11) Questionnaire
  • Self-Perception of Age (SPA) measure
  • Glabellar Line Scale - Physician Observer
  • Lateral Canthal Line Scale - Physician Observer
  • Horizontal Forehead Line Scale - Physician Observer
  • Nasolabial Fold Scale (Wrinkle Assessment Scale)
  • Marionette Lines Grading Scale - Physician Observer
Same as current
Complete list of historical versions of study NCT01269801 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds
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

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.

  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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Wrinkles
  • 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.

    Other Names:
    • Europe Investigative Sites:
    • VISTABEL® (Botulinum toxin type A) for Injection
  • 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.

    Other Names:
    • EU Investigative Sites:
    • JUVÉDERM® Ultra 2 and JUVÉDERM® Ultra 3 Injectable Gel
  • Active Comparator: Botox Cosmetic
    onabotulinumtoxinA for injection
    Intervention: Drug: onabotulinumtoxinA
  • Active Comparator: JUVÉDERM
    JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
    Intervention: Drug: JUVÉDERM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2012
September 2011   (final data collection date for primary outcome measure)

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.
Both
25 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01269801
JUVE_BTX-09-01
Yes
AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC
AboutSkin Dermatology and DermSurgery, PC
Allergan
Principal Investigator: Joel L Cohen, MD AboutSkin Dermatology and DermSurgery, PC
AboutSkin Dermatology and DermSurgery, PC
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP