Phase 3
N=171
A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old
Temple Hollowing
Bottom Line
View on ClinicalTrials.gov: NCT04414397 ↗Enrolled (actual)
171
Serious AEs
4.9%
Results posted
Apr 2024
Primary outcome: Primary: Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3 — 13.5; 80.4 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- JUVÉDERM® VOLUMA® XC (Device); No-treatment control (Other)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3 |
13.5; 80.4 | <0.0001 sig |
| PRIMARY Number of Participants With Adverse Events |
3; 38; 24; 13; 2; 5 | — |
| SECONDARY Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3 |
10.7; 83.8 | — |
| SECONDARY Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3 |
2.0; 92.9 | — |
| SECONDARY Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3 |
-6.6; 24.2 | <0.0001 sig |
| SECONDARY Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire |
-4.2; 42.7 | <0.0001 sig |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04414397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.