Temple HollowingPhase 3NCT04891419

JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population

A Phase 3 study testing JUVÉDERM® VOLUMA® with Lidocaine in people with Temple Hollowing, run by Allergan at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Temple Hollowing
What is being tested?: JUVÉDERM® VOLUMA® with Lidocaine
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: 8 sitesChina
Study dates: 20 Jul 2021to 22 Nov 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 23Show fewer

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

China-Japan Friendship Hospital /ID# 241680
Beijing, Beijing Municipality, 100029
Beijing Hospital /ID# 233582
Beijing, Beijing Municipality, 100730
Peking University International Hospital /ID# 242166
Beijing, 102206
Nanjing Drum Tower Hospital /ID# 233607
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University /ID# 233604
Nanjing, Jiangsu, 210009
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 233571
Shanghai, Shanghai Municipality, 200011
Shanghai Sixth People's Hospital /ID# 233568
Shanghai, Shanghai Municipality, 200233
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233602
Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population

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.

Conditions: Temple Hollowing
Being tested: JUVÉDERM® VOLUMA® with Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JUVÉDERM® VOLUMA® with LidocaineDevice
JUVÉDERM® VOLUMA® with Lidocaine injectable gel

Study groups in NCT04891419
Study group	Role	What they receive
JUVÉDERM® VOLUMA® with Lidocaine	Experimental	Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch up treatment Receives: Device: JUVÉDERM® VOLUMA® with Lidocaine
Control- No treatment	No intervention	No treatment is administered. Optional treatment at month 6.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
Measured: Up to 14 Months
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)
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.
Measured: Change from Baseline to Month 6

Secondary outcomes (4)

Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6
Participant-assessed satisfaction using the 12-item FACE-Q Satisfaction with Temples Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Measured: Change from Baseline to Month 6
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6
Participant-assessed satisfaction using the 10-item FACE-Q Satisfaction with Facial Appearance Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Measured: Change from baseline to Month 6
Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS)
Participant will assess temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
Measured: Month 6
Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 202122 Nov 2023

First posted18 May 2021
Study start20 Jul 2021
Primary completion22 Nov 2023
Study completion22 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Temple HollowingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04891419
Sponsor's protocol ID: 1878-701-008
Status last verified: Dec 2024
First submitted: 14 May 2021
Last updated: 12 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Prospective, Multicenter, Randomized, No-treatment Controlled, Assessor-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Gel for Injection to Improve Temple Hollowing in Chinese Adults
Temple Hollowing

All Temple Hollowing trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population
ClinicalTrials.gov ID: NCT04891419
Acronym / sponsor ID: 1878-701-008
Conditions: Temple Hollowing
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 20 Jul 2021 (actual)
Primary completion: 22 Nov 2023 (actual)
Study completion: 22 Nov 2023 (actual)
First posted: 18 May 2021 (actual)
Results: Posted 12 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
JUVÉDERM® VOLUMA® with Lidocaine	Experimental	Device: JUVÉDERM® VOLUMA® with LidocaineParticipants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch up treatment
Control- No treatment	No intervention	–No treatment is administered. Optional treatment at month 6.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JUVÉDERM® VOLUMA® with LidocaineJUVÉDERM® VOLUMA® with Lidocaine injectable gel	Device	JUVÉDERM® VOLUMA® with Lidocaine

Primary outcome

Number of Participants With Adverse Events
Time frame: Up to 14 Months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
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)
Time frame: Change from Baseline to Month 6
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.

4 secondary outcomes

Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6
Time frame: Change from Baseline to Month 6
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6
Time frame: Change from baseline to Month 6
Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 6
Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 6

Results and safety

Results posted to the registry on 12 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)	112	107
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)	56	53

Primary outcome: Number of Participants With Adverse Events

Time frame: Up to 14 Months. Count of participants. Unit: Participants

Measure	Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) n = 56	JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) n = 112
Any TEAE	23	59
TESAE	1	2

Population analysed: Control Period - Safety Population

Primary outcome: 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)

Time frame: Change from Baseline to Month 6. Number. Unit: participants

Measure	Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) n = 56	JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) n = 101
Value	0	92

Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) vs JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12): Rate Difference: 91.1 (95% CI 83.7 to 95.9), p <.0001, Fisher Exact

Population analysed: Control Period - Observed Primary Endpoint Population N = Participants with analysis values at both baseline and Month 6 Visit.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control - No Treatment (Months 1 - 6)	1 of 56 (1.8%)	18 of 56 (32.1%)	0 of 56
JUVÉDERM® VOLUMA® With Lidocaine (Months 1 - 12)	3 of 112 (2.7%)	62 of 112 (55.4%)	0 of 112
JUVÉDERM® VOLUMA® With Lidocaine - Post Control (Months 7 - 12)	2 of 53 (3.8%)	19 of 53 (35.8%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Related trials for Temple Hollowing

Recruiting
A Prospective, Multicenter, Randomized, No-treatment Controlled, Assessor-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Gel for Injection to Improve Temple Hollowing in Chinese Adults
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ALLERGAN, INC. study director

Allergan

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JUVÉDERM® VOLUMA® with Lidocaine in people with Temple Hollowing, run by Allergan at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Up to 14 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04891419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (6 listed)

Key exclusion criteria (23 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Number of Participants With Adverse Events

Primary outcome: 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)

Adverse events

Research links

Related trials for Temple Hollowing

A Prospective, Multicenter, Randomized, No-treatment Controlled, Assessor-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Gel for Injection to Improve Temple Hollowing in Chinese Adults

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Number of Participants With Adverse Events

Primary outcome: 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)

Adverse events