Phase 3
N=168
JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population
Temple Hollowing
Bottom Line
View on ClinicalTrials.gov: NCT04891419 ↗Enrolled (actual)
168
Serious AEs
2.7%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Adverse Events — 23; 59; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- JUVÉDERM® VOLUMA® with Lidocaine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
23; 59; 1; 2 | — |
| PRIMARY Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS) |
0; 92 | <.0001 sig |
| SECONDARY Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6 |
0.1; 50.7 | <.0001 sig |
| SECONDARY Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6 |
-4.1; 36.2 | <.0001 sig |
| SECONDARY Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS) |
0; 94 | <.0001 sig |
| SECONDARY Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) |
0; 93 | <.0001 sig |
Summary
The objectives of this study are to evaluate the safety and effectiveness of JUVÉDERM® VOLUMA® with Lidocaine injectable gel in adult Chinese population seeking correction of temple hollowing.
Eligibility Criteria
Inclusion Criteria
- Participant must be 18 or over, at the time of signing the ICF
- Participants seeking improvement of temple hollowing
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
- Written informed consent from the participant has been obtained prior to any study-related procedures
- Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
- Is able to complete effectiveness self-assessments without the use of glasses (contact lens use is acceptable if they will be used for all participant self-assessments)
Exclusion Criteria
- Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired
- Has experienced trauma to the temple area within 6 months before enrollment or has residual deficiencies, deformities, or scarring
- Temporal arteritis or history of temporal arteritis
- Temporomandibular joint dysfunction or any other jaw issues
- Recurrent temporal headaches such as temporal tendinitis migraine
- Active or recurrent inflammation or infection in either eye
- Tendency to develop hypertrophic scarring
- Active autoimmune disease
- History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
- Current cutaneous or mucosal inflammatory or infectious processes (e.g. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, above the subnasal
- 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 12 months before enrollment
- Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment (examples of mesotherapy or cosmetic facial procedures are laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures.
- Injections in the nasolabial fold are acceptable only if done at least 3 months prior to enrollment
- Botulinum toxin treatment above the subnasale within 6 months before enrollment
- Has braces or other orthodontics
- Not eligible for this study if participants have begun using any new over the counter or prescription oral or tropical, anti-wrinkle products above the subnasale within 30 days before enrollment. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study
- Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)
- Has tattoos, piercings, facial hair, or scars above and including the subnasale that would interfere with visual assessment of the temple
- Females who are pregnant, nursing, or planning a pregnancy
- Plans a significant weight change (more than 10% of body weight) during the study
Data sourced from ClinicalTrials.gov (NCT04891419). 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.