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Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions

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ClinicalTrials.gov Identifier: NCT02437903
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : May 16, 2017
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Baumann Cosmetic and Research Institute

Brief Summary:
This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the facial temporal regions based on the change in the score of the investigator's Temporal. This study will be an open label, single center study.

Condition or disease Intervention/treatment Phase
Aging Device: JUVÉDERM VOLUMA™ XC Not Applicable

Detailed Description:

Volume deficit in the temporal area (the side of the forehead) of the face is a common sign of aging.

JUVÉDERM VOLUMA™ XC is a dermal filler, which was FDA-approved in October 2013 for the improvement and correction of age-related volume deficit in the mid-face area.

JUVÉDERM VOLUMA™ XC is a gel implant composed of 20 mg/mL hyaluronic acid (HA) formulation, produced by Streptococcus equi bacteria, and 0.3 w/w lidocaine. JUVÉDERM VOLUMA™ XC is a clear, sterile, and biodegradable gel indicated for subcutaneous and/or supraperiosteal injection.

JUVÉDERM VOLUMA™ XCwill be injected in the temple area and subjects will be followed for 12 months.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Single-center Study, Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions
Actual Study Start Date : August 7, 2015
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : April 5, 2017

Arm Intervention/treatment
JUVÉDERM VOLUMA™ XC
Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
Device: JUVÉDERM VOLUMA™ XC
Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12.
Other Name: Injectable Dermal Filler




Primary Outcome Measures :
  1. Frontal Temporal Fossa Rating Scale [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 ]
    Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.


Secondary Outcome Measures :
  1. Investigator's Satisfaction With the Appearance of the Temporal Regions [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 ]
    Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient's right side and not the investigator's right side.


Other Outcome Measures:
  1. Subject's Satisfaction With Temple Appearance [ Time Frame: Baseline, month 1, month 3, month 6, month 9, and Month 12 ]
    Subject's Satisfaction with Temple Appearance

  2. Subject Self-Perception of Age [ Time Frame: Baseline, month 1, month 3, month 6, month 9, and Month 12 ]
    Subjects perception of age when the subject looks at his/her right and left temples

  3. Number of Participants With Specific Site Treatment Responses [ Time Frame: Day 14 ]
    Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to read and sign the informed consent and other study documents.
  • Treating investigator's score of 3, 4, or 5 on the Temporal Fossa Rating Scale.
  • Written informed consent has been obtained prior to any study-related procedures.
  • Written Authorization for Use and Release of Health and Research Study Information has been signed.
  • Ability to follow study instructions and complete study assessment tools including the subject diary
  • Female patients of childbearing potential must have a negative urine pregnancy test result and not be lactating.
  • Likely to complete all required visits with no plans to move from Miami in the next 12 months
  • Agree to not undergo other treatments or cosmetic procedures in the treatment area during the study such as facial laser treatments, botulinum toxin, hyaluronic acid injections, subcutaneous fat injections, any other permanent or semi-permanent facial fillers.

Exclusion Criteria:

  • Any uncontrolled systemic disease
  • History of any of the following conditions: vision loss not corrected by lenses or LASIX surgery; glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease.
  • Have a history of severe allergic/anaphylactic reactions or multiple allergies.
  • Conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma.
  • Females planning to become pregnant, are pregnant, or are breast-feeding.
  • History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit
  • Have severe thin skin, in the treatment area as determined by the PI.
  • Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months in the treatment area. Have had neuromodulator injections, mesotherapy, or resurfacing (laser or other ablative or non-ablative procedures) within 5 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study.
  • Have undergone facial plastic surgery (with the exception of rhinoplasty or a brow lift), tissue grafting, or tissue augmentation with silicone, fat, or other permanent or semi-permanent dermal fillers or be planning to undergo any of these procedures affecting the treatment area, at any time during the study.
  • Unwilling to undergo injections in the temple area.
  • Have a history of migraines or frequent headaches, as determined by the PI.
  • Have blindness or partial vision loss in either eye.
  • Have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations.
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
  • Patient who has a condition or is in a situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.
  • Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g.,warfarin), anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection. A wash out period of 10 days is allowed.
  • Have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437903


Locations
United States, Florida
Baumann Cosmetic and Research Institute
Miami, Florida, United States, 33137
Sponsors and Collaborators
Baumann Cosmetic and Research Institute
Investigators
Principal Investigator: Leslie S Baumann, MD,CPI Baumann Cosmetic and Research Institute
  Study Documents (Full-Text)

Documents provided by Baumann Cosmetic and Research Institute:
Informed Consent Form  [PDF] August 13, 2015


Responsible Party: Baumann Cosmetic and Research Institute
ClinicalTrials.gov Identifier: NCT02437903     History of Changes
Other Study ID Numbers: Voluma Temporal 2014
First Posted: May 8, 2015    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: February 15, 2018
Last Verified: January 2018

Keywords provided by Baumann Cosmetic and Research Institute:
voluma temporal, facial, volume loss

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents