The Volumizing Effect of Juvéderm VOLUMA® in the Mid-Face

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT01559064
First received: March 19, 2012
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

This is a prospective, observational study of the volumizing effect of aesthetic use of Juvéderm VOLUMA® with lidocaine in the mid-face area.


Condition Intervention
Age-related Volume Deficit in the Mid-face
Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study of the Volumizing Effect of Open-Label Aesthetic Use of VOLUMA® in the Mid-Face Area

Resource links provided by NLM:


Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Subject Experience Measured by Patient Satisfaction Questionnaire [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy


Enrollment: 115
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Age group A
Subjects 30 to 40 years old
Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)
All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
Other Name: Juvéderm VOLUMA® with lidocaine
Age group B
Subjects 40 to 50 years old
Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)
All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
Other Name: Juvéderm VOLUMA® with lidocaine
Age group C
Subjects over 50 years old
Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)
All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
Other Name: Juvéderm VOLUMA® with lidocaine

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Normal, healthy subjects desiring aesthetic improvement

Criteria

Inclusion Criteria:

  • Desire and willingness for correction of asymmetry or enhancement of his/her mid-face area.
  • Be willing to undergo treatment for volume loss in the face area
  • Females and males ≥30 years of age
  • Be in good health as of the opinion of the Investigator
  • Sign the Informed Consent Form prior to any study-related procedures being performed
  • Have established a realistic treatment goal that the Investigator agrees is achievable i.e., have realistic expectations of aesthetic results

Exclusion Criteria:

  • Have extensive tissue damage that could affect the aesthetic outcome
  • Have a known allergy to any component of VOLUMA® with lidocaine injections
  • Have an abscess or infection at the time of treatment that in the opinion of the Investigator does not make the subject eligible for the procedure.
  • Have undergone cosmetic facial [e.g., face-lift, or other surgeries, which may alter the appearance of the mid-face region (laser, photomodulation intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or meso-therapy] anywhere in the mid-face region, or Botox® Cosmetic injections in the lower face (below the orbital rim), within the 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with hyaluronic acid (HA) fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
  • Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
  • Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study
  • Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression)
  • Have a history of or currently suffer from an autoimmune disease (e.g., Rheumatoid arthritis, Crohn's disease)
  • Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications)
  • Have a history of skin cancer
  • Suffer from Porphyria
  • Have epilepsy which is not controlled by anti-epilepsy therapy
  • Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes, etc.)
  • Have a history of treatment with interferon therapy (e.g., warfarin) or have taken non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or ginko biloba) within 10 days of undergoing study device injection. NOTE: Study device injection may be delayed as necessary to accommodate this 10-day washout period
  • Be on a concurrent regimen of high doses of lidocaine (more than 400 mg) which may cause acute toxic reactions
  • Be on a concurrent regimen of other local anesthetics structurally related to amide-type local anesthetics
  • Have impaired cardiac conduction, severly impaired hepatic function, or severe renal dysfunction
  • Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559064

Locations
Belgium
Aalst, Belgium
Germany
Koln, North Rhine-Westphalia, Germany
Netherlands
Naarden, Netherlands
United Kingdom
Mere Green, United Kingdom
Sponsors and Collaborators
Allergan Medical
Investigators
Study Director: Medical Monitor Allergan Medical
  More Information

No publications provided

Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT01559064     History of Changes
Other Study ID Numbers: MAF/AGN/MED/FIL/017
Study First Received: March 19, 2012
Results First Received: March 21, 2013
Last Updated: June 6, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014