Temple HollowingNCT03166618

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

A study testing Juvéderm® VOLUMA XC in people with Temple Hollowing, run by Allergan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 22 years and older
Conditions the study is for: Temple Hollowing
What is being tested?: Juvéderm® VOLUMA XC
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2017to 21 Jul 2017
Phase: Interventional
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 19Show fewer

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
Has porphyria or untreated epilepsy
Has active autoimmune disease
Has current cutaneous or mucosal inflammatory or infectious processes
Is on a lidocaine, anticoagulation therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, 90069

Other trials in United States

About this study

Official title: A Multicenter, Single-Blind, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing

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
Being tested: Juvéderm® VOLUMA XC

What participants receive

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

Juvéderm® VOLUMA XCDevice
Juvéderm® VOLUMA XC hyaluronic acid injectable gel

Study groups in NCT03166618
Study group	Role	What they receive
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. Receives: Device: Juvéderm® VOLUMA XC
Control_No Treatment	No intervention	No treatment is administered.

What is being measured

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

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.
Measured: 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)
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. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.
Measured: Month 3
Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS
The participant will assess their temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.
Measured: Month 3

Timeline

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

24 Apr 201721 Jul 2017

First posted25 May 2017
Study start24 Apr 2017
Primary completion21 Jul 2017
Study completion21 Jul 2017

Why it stopped: Business decision to stop the program.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03166618
Sponsor's protocol ID: VOLUMA-007
Status last verified: Oct 2018
First submitted: 6 Mar 2017
Last updated: 18 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Single-Blind, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
ClinicalTrials.gov ID: NCT03166618
Acronym / sponsor ID: VOLUMA-007
Conditions: Temple Hollowing
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision to stop the program.
Enrolment: 1 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 24 Apr 2017 (actual)
Primary completion: 21 Jul 2017 (actual)
Study completion: 21 Jul 2017 (actual)
First posted: 25 May 2017 (actual)
Results: Posted 18 Oct 2018

Clinical summary

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

This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants 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
VOLUMA® XC Treatment	Experimental	Device: Juvéderm® VOLUMA XCParticipants 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.
Control_No Treatment	No intervention	–No treatment is administered.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (19 listed)

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

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 XCJuvéderm® VOLUMA XC hyaluronic acid injectable gel	Device	VOLUMA® XC Treatment

Primary outcome

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)
Time frame: Change from Baseline to Month 3
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.

2 secondary outcomes

Percentage of Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 3
Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS
Time frame: Month 3

Results and safety

Results posted to the registry on 18 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VOLUMA® XC Treatment	0	0
Control_No Treatment	1	0

Primary outcome: 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)

Time frame: Change from Baseline to Month 3

Population analysed: Up to 189 subjects were planned; 1 subject was enrolled in the control\_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VOLUMA® XC Treatment	0 of 0	0 of 0	0
Control_No Treatment	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): Due to low patient enrollment, the target number of participants needed to achieve target power and statistically reliable results was not met.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
Temple Hollowing

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.

Nikki Amaratunge study director

Allergan

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

Questions about this trial

What is this clinical trial studying?

A study testing Juvéderm® VOLUMA XC in people with Temple Hollowing, run by Allergan at 1 site in United States.

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 1 inclusion and 19 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: stopped early, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2018). 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?

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) (time frame: Change from Baseline to Month 3). 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 NCT03166618.

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 18 Oct 2018.

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 (1 listed)

Key exclusion criteria (19 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: 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)

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: 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)

Adverse events