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
  Purpose

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.


Condition Intervention Phase
Wrinkles
Drug: onabotulinumtoxinA
Drug: JUVÉDERM
Phase 4

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

Resource links provided by NLM:


Further study details as provided by AboutSkin Dermatology and DermSurgery, PC:

Primary Outcome Measures:
  • 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


Enrollment: 150
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botox Cosmetic
onabotulinumtoxinA for injection
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
Active Comparator: JUVÉDERM
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
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

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
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269801

Locations
United States, Colorado
About Skin Dermatology
Englewood, Colorado, United States, 80113
Canada, Ontario
Niagara Falls Dermantology and Skin Care Center
Niagara Falls, Ontario, Canada, L2E 7H1
University of Toronto
Toronto, Ontario, Canada, M5R3N8
Sponsors and Collaborators
AboutSkin Dermatology and DermSurgery, PC
Allergan
Investigators
Principal Investigator: Joel L Cohen, MD AboutSkin Dermatology and DermSurgery, PC
  More Information

No publications provided

Responsible Party: AboutSkin Dermatology, Joel L. Cohen, MD, AboutSkin Dermatology and DermSurgery, PC
ClinicalTrials.gov Identifier: NCT01269801     History of Changes
Other Study ID Numbers: JUVE_BTX-09-01
Study First Received: January 2, 2011
Last Updated: July 11, 2013
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Germany: Ethics Commission

Keywords provided by AboutSkin Dermatology and DermSurgery, PC:
BOTOX
JUVEDERM
Prospective
Open Label
Randomized
Crossover Study

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014