Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing

NCT03166618 | Terminated Results FDA Device

• 1 other identifier: VOLUMA-007
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.

Conditions

Temple Hollowing

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator Using the Allergan Temple Hollowing Scale (ATHS)

  The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.

  Change from Baseline to Month 3

Secondary Outcomes (2)

• Percentage of Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)

  Month 3

• Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS

  Month 3

Study Arms (2)

VOLUMA® XC Treatment

EXPERIMENTAL

Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.

Device: Juvéderm® VOLUMA XC

Control_No Treatment

NO INTERVENTION

No treatment is administered.

Interventions

Juvéderm® VOLUMA XC DEVICE

Juvéderm® VOLUMA XC hyaluronic acid injectable gel

VOLUMA® XC Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has temple hollowing and is seeking restoration in the temple area.

You may not qualify if:

• Has temple hollowing due to due to trauma, congenital malformations, or lipodystrophy
• Has received permanent facial implants in the face or neck
• Has undergone fat injections
• Has tattoos, piercings, facial hair or scars that would interfere with visual assessment of the temple
• Has undergone semipermanent dermal filler treatment in the temple or mid-face within the past 36 months
• Has undergone dermal filler injections above the subnasale within the past 24 months
• Has temporal arteritis or history of temporal arteritis
• Has temporomandibular joint dysfunction
• Has eye inflammation or infection
• Has a history of detached retina, retinal vascular occlusion, narrow angle glaucoma, or neovascular eye disease
• Has ever received a facelift, browlift, or facial reconstructive surgery
• Has undergone mesotherapy or cosmetic treatment (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck or botulinum toxin injections within the past 6 months
• Has experienced trauma to the temple within the past 6 months or has residual deficiencies, deformities, or scarring
• Has a tendency to develop hypertrophic scarring
• Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Skin Care and Laser Physicians of Beverly Hills

Los Angeles, California, 90069, United States

Location

Related Links

• More Information

Limitations and Caveats

Due to low patient enrollment, the target number of participants needed to achieve target power and statistically reliable results was not met.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan Sales LLC

IR-CTRegistration@allergan.com

877-277-8566

Study Officials

• Nikki Amaratunge

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: May 25, 2017
• Study Start: April 24, 2017
• Primary Completion: July 21, 2017
• Study Completion: July 21, 2017
• Last Updated: October 18, 2018
• Results First Posted: October 18, 2018

Record last verified: 2018-10

Locations

US (1)