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

NCT02437903 | Completed Results

• 1 other identifier: Voluma Temporal 2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

voluma temporal, facial, volume loss

Outcome Measures

Primary Outcomes (1)

• Frontal Temporal Fossa Rating Scale

  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.

  Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

Secondary Outcomes (1)

• Investigator's Satisfaction With the Appearance of the Temporal Regions

  Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

Other Outcomes (3)

• Subject's Satisfaction With Temple Appearance

  Baseline, month 1, month 3, month 6, month 9, and Month 12

• Subject Self-Perception of Age

  Baseline, month 1, month 3, month 6, month 9, and Month 12

• Number of Participants With Specific Site Treatment Responses

  Day 14

Study Arms (1)

JUVÉDERM VOLUMA™ XC

OTHER

Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.

Device: JUVÉDERM VOLUMA™ XC

Interventions

JUVÉDERM VOLUMA™ XC DEVICE

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.

Also known as: Injectable Dermal Filler

JUVÉDERM VOLUMA™ XC

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baumann Cosmetic and Research Institute: lead

Study Sites (1)

Baumann Cosmetic and Research Institute

Miami, Florida, 33137, United States

Location

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Leslie Baumann, MD
• Organization: Baumann Cosmetic and Research Institute

studies@derm.net

(305) 531-5788

Study Officials

• Leslie S Baumann, MD,CPI

  Baumann Cosmetic and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 8, 2015
• Study Start: August 7, 2015
• Primary Completion: April 5, 2017
• Study Completion: April 5, 2017
• Last Updated: February 15, 2018
• Results First Posted: May 16, 2017

Record last verified: 2018-01

Locations

US (1)