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

NCT01559064 | Completed Results

• 1 other identifier: MAF/AGN/MED/FIL/017
• Study Type: observational
• Target: 115
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

Age-related Volume Deficit in the Mid-face

Outcome Measures

Primary Outcomes (1)

• Subject Experience Measured by Patient Satisfaction Questionnaire

  Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy

  3 weeks

Study Arms (3)

Age group A

Subjects 30 to 40 years old

Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)

Age group B

Subjects 40 to 50 years old

Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)

Age group C

Subjects over 50 years old

Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)

Interventions

Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) DEVICE

All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.

Also known as: Juvéderm VOLUMA® with lidocaine

Age group A; Age group B; Age group C

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Normal, healthy subjects desiring aesthetic improvement

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan Medical: lead

Study Sites (4)

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Cologne, North Rhine-Westphalia, Germany

Location

Unknown Facility

Naarden, Netherlands

Location

Unknown Facility

Mere Green, United Kingdom

Location

Related Publications (1)

• Philipp-Dormston WG, Eccleston D, De Boulle K, Hilton S, van den Elzen H, Nathan M. A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvederm(R) VOLUMA(R) with Lidocaine in mid-face area. J Cosmet Laser Ther. 2014 Aug;16(4):171-9. doi: 10.3109/14764172.2014.910079. Epub 2014 May 5.

  PMID: 24689357 RESULT

Results Point of Contact

• Title: Medical Monitor
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Monitor

  Allergan Medical

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 13, 2014
• Results First Posted: June 10, 2013

Record last verified: 2014-06

Locations

BE (1); DE (1); GB (1); NL (1)