A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old

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Allergan

Status and phase

Completed
Phase 3

Conditions

Temple Hollowing

Treatments

Device: JUVÉDERM® VOLUMA® XC
Other: No-treatment control

Study type

Interventional

Funder types

Industry

Identifiers

NCT04414397
1878-702-008

Details and patient eligibility

About

The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing

Enrollment

205 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants in general good health
  • Participants seeking improvement of temple hollowing

Exclusion criteria

  • Temple hollowing due to trauma, congenital malformations, or lipodystrophy
  • Temporomandibular joint dysfunction or any other jaw issues
  • Recurrent temporal headaches such as temporal tendinitis migraine
  • Active autoimmune disease
  • History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
  • Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
  • Fat injection or permanent facial implants anywhere in the face
  • Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
  • Temporary dermal filler injections above the subnasale within 24 months before enrollment
  • Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment
  • Botulinum toxin treatment above the subnasale within 6 months before enrollment
  • Females who are pregnant, nursing, or planning a pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

205 participants in 2 patient groups

No Treatment then JUVÉDERM® VOLUMA® XC
Other group
Description:
Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.
Treatment:
Other: No-treatment control
Device: JUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC
Experimental group
Description:
Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Treatment:
Device: JUVÉDERM® VOLUMA® XC

Trial documents
2

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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