Skin Smoothness of the CheeksNCT03728309

JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness

A study testing JUVÉDERM VOLITE™ XC in people with Skin Smoothness of the Cheeks, run by Allergan at 14 sites in 2 countries.

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

This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Skin Smoothness of the Cheeks
What is being tested?: JUVÉDERM VOLITE™ XC
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 209 participants
Where: 14 sitesin 2 countries
Study dates: 9 Nov 2018to 17 Jul 2020
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

Ability to follow study instructions and likely to complete all required visits;
Written informed consent and data privacy consent have been obtained

Who cannot join

Has undergone tissue augmentation with dermal fillers including hyaluronic acid (HA), calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg, face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the fact within 12 months before screening or is planning to undergo any such treatment during the study;
Has received any crosslinked HA filler in any anatomic area within 12 months of screening;
Has undergone treatment with botulinum toxin in the cheek area (including crow's feet) within 6 months of screening or is planning to undergo such treatment during the study;
Has ever received semi-permanent fillers or permanent facial implants (eg, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafuoroethylene) anywhere in the face or is planning to be implanted with any of these products at any time during the study;
Has facial tattoos, piercings, pigmentation, hair (ie, beard, mustache), or past trauma that would interfere with the visualization of the face for the effectiveness assessments;
Has undergone a dental procedure within 6 weeks before treatment or plans to undergo a dental procedure (other than prophylasix or dental fillings) during the course of the study;

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Has tendency to develop hypertrophic scarring;
Has a history of allergy to lidocaine, HA products, and/or to gram-positive bacterial proteins as HA is produced by Streptococcus-type bacteria, or is planning to undergo desensitization therapy during the term of the study;
Has a history of anaphylactic shock;
Has current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face (injection may be delayed to allow subjects with a history of recurrent oral herpes to take prophylactic antiviral/herpes medication for 2 days);
Is on an ongoing regimen of anticoagulation therapy (eg, warfarin) or is known to have a coagulation disorder;
Is on an ongoing regimen of medications (eg, aspirin, ibuprofen) or other substances (eg, herbal supplements with garlic, ginkgo biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection (study device injection may be delayed as necessary to accommodate this 10-day washout period);
Has active autoimmune disease;
Has received any investigational product within 30 days before enrollment or is planning to participate in another investigation during the course of this study; - Has begun using any over-the-counter or prescription, oral or topical, anti-wrinkle products on the face within 30 days before enrollment or is planning to begin using such products during the study (subjects 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);
Females who are pregnant, nursing, or planning a pregnancy during the study;
Is an employee (or a relative of an employee) of the principal investigator (PI)/evaluating investigator (EI)/treating investigator(TI)/site, Allergan, or representative of Allergan'
Has a condition or is in a situation which, in the TI's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States13 sites

Facial Plastic Surgery Center /ID# 234876
Baltimore, Maryland, 21208
Clinical Research Center of the Carolinas /ID# 236488
Charleston, South Carolina, 29407
Dermatology Laser and Vein Specialists of Carolinas /ID# 236169
Charlotte, North Carolina, 28207
Skincare Physicians /ID# 235383
Chestnut Hill, Massachusetts, 02467
Skin Research Institute LLC
Coral Gables, Florida, 33146
Dallas Center for Dermatology and Aesthetics /ID# 234452
Dallas, Texas, 75225-6203
Kathleen L. Behr M.D. Inc /ID# 236170
Fresno, California, 93720
Advanced Dermatology /ID# 234879
Lincolnshire, Illinois, 60069
Dermatology Research Associates /ID# 237649
Los Angeles, California, 90045
Dermatology and Laser Surgery Center of New York /ID# 234571
New York, New York, 10028
Ava MD
Santa Monica, California, 90404
Art of Skin MD
Solana Beach, California, 92075
Dermatology PartnersInc. /ID# 234946
Wellesley, Massachusetts, 02481

Other trials in United States

Puerto Rico1 site

Jose Raul Montes Eyes & Facial Rejuvenation
San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: Protocol Title: A Randomized, Multicenter, Evaluator-blind, Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLITE™ XC Injectable Gel for the Improvement in Cheek Skin Smoothness

This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval.

Conditions: Skin Smoothness of the Cheeks
Being tested: JUVÉDERM VOLITE™ XC

What participants receive

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

JUVÉDERM VOLITE™ XCDevice
Intradermal, needle in multiple microdepot injections across both cheeks.

Study groups in NCT03728309
Study group	Role	What they receive
JUVÉDERM® VOLITE™	Experimental	Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 milliliters (mL) on Day 1 followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4 mL at Month 6, if applicable. Receives: Device: JUVÉDERM VOLITE™ XC
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™	Experimental	Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable. Receives: Device: JUVÉDERM VOLITE™ XC

What is being measured

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

Percentage of Participants With at Least 1-point Improvement (Decrease) From Baseline on the Allergan Cheek Smoothness Scale (ACSS) on Both Cheeks at Month 1
The ACSS is a validated 5-point ordinal scale developed by Allergan to grade the severity of skin smoothness on the cheeks. The score ranges from 0 (smooth visual skin texture) to 4 (extremely coarse visual skin texture, crosshatched deep creases, extreme elastosis. Responders are participants with at least 1-point improvement (decrease) from baseline on the ACSS on both cheeks based on evaluating investigator (EI) assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period. The multiple imputation method for the missing data imputation was used for analysis.
Measured: Baseline to Month 1
Number of Participants Who Experience One or More Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical device which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study device. An AE was considered a treatment emergent adverse event (TEAE) if the AE began or worsened (increased in severity or became serious) after first administration of VOLITE for the treatment group and after the date of randomization for the control group.
Measured: From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)

Secondary outcomes (2)

Change From Baseline in Face-Q Satisfaction With Skin Questionnaire at Month 1
The participant assessed satisfaction using the 12 items on the FACE-Q: Satisfaction with Skin questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied. The responses to the 12 items were summed and converted to a scale score that ranges from 0 (worst) to 100 (best). Higher score indicates more satisfaction. A positive change from baseline indicates improvement.
Measured: Baseline and Month 1
Percentage of Participants With at Least 1-Point Improvement (Decreased) From Baseline on Both Cheeks in the Allergan Fine Lines Scale (AFLS) Response at Month 1
The AFLS is a validated 5-point ordinal scale developed by Allergan to grade the severity of fine lines on the cheeks. The score ranges from 0 (no fine lines) to 4 (diffuse superficial lines, crosshatching). Responders are participants with at least 1-point improvement (decrease) from baseline on the AFLS on both cheeks based on observed data of EI assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period.
Measured: Baseline to Month 1

Timeline

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

9 Nov 201817 Jul 2020

First posted2 Nov 2018
Study start9 Nov 2018
Primary completion17 Jul 2020
Study completion17 Jul 2020

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 Skin Smoothness of the CheeksStudies 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: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03728309
Sponsor's protocol ID: 1867-701-008
Status last verified: Nov 2022
First submitted: 31 Oct 2018
Last updated: 19 Dec 2022
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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol Title: A Randomized, Multicenter, Evaluator-blind, Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLITE™ XC Injectable Gel for the Improvement in Cheek Skin Smoothness
ClinicalTrials.gov ID: NCT03728309
Acronym / sponsor ID: 1867-701-008
Conditions: Skin Smoothness of the Cheeks
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 9 Nov 2018 (actual)
Primary completion: 17 Jul 2020 (actual)
Study completion: 17 Jul 2020 (actual)
First posted: 2 Nov 2018 (actual)
Results: Posted 19 Dec 2022

Clinical summary

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

This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval.

Study design

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

Arm	Type	Receives
JUVÉDERM® VOLITE™	Experimental	Device: JUVÉDERM VOLITE™ XCParticipants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 milliliters (mL) on Day 1 followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4 mL at Month 6, if applicable.
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™	Experimental	Device: JUVÉDERM VOLITE™ XCParticipants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable.

Who may qualify

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

Key inclusion criteria (2 listed)

Ability to follow study instructions and likely to complete all required visits;
Written informed consent and data privacy consent have been obtained

Key exclusion criteria (17 listed)

Has undergone tissue augmentation with dermal fillers including hyaluronic acid (HA), calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg, face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the fact within 12 months before screening or is planning to undergo any such treatment during the study;
Has received any crosslinked HA filler in any anatomic area within 12 months of screening;
Has undergone treatment with botulinum toxin in the cheek area (including crow's feet) within 6 months of screening or is planning to undergo such treatment during the study;
Has ever received semi-permanent fillers or permanent facial implants (eg, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafuoroethylene) anywhere in the face or is planning to be implanted with any of these products at any time during the study;
Has facial tattoos, piercings, pigmentation, hair (ie, beard, mustache), or past trauma that would interfere with the visualization of the face for the effectiveness assessments;

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 VOLITE™ XCIntradermal, needle in multiple microdepot injections across both cheeks.	Device	Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™, JUVÉDERM® VOLITE™

Primary outcome

Percentage of Participants With at Least 1-point Improvement (Decrease) From Baseline on the Allergan Cheek Smoothness Scale (ACSS) on Both Cheeks at Month 1
Time frame: Baseline to Month 1
The ACSS is a validated 5-point ordinal scale developed by Allergan to grade the severity of skin smoothness on the cheeks. The score ranges from 0 (smooth visual skin texture) to 4 (extremely coarse visual skin texture, crosshatched deep creases, extreme elastosis. Responders are participants with at least 1-point improvement (decrease) from baseline on the ACSS on both cheeks based on evaluating investigator (EI) assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period. The multiple imputation method for the missing data imputation was used for analysis.
Number of Participants Who Experience One or More Treatment Emergent Adverse Event (TEAE)
Time frame: From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical device which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study device. An AE was considered a treatment emergent adverse event (TEAE) if the AE began or worsened (increased in severity or became serious) after first administration of VOLITE for the treatment group and after the date of randomization for the control group.

2 secondary outcomes

Change From Baseline in Face-Q Satisfaction With Skin Questionnaire at Month 1
Time frame: Baseline and Month 1
Percentage of Participants With at Least 1-Point Improvement (Decreased) From Baseline on Both Cheeks in the Allergan Fine Lines Scale (AFLS) Response at Month 1
Time frame: Baseline to Month 1

Results and safety

Results posted to the registry on 19 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™	73	61
JUVÉDERM VOLITE™ XC	136	112

Primary outcome: Percentage of Participants With at Least 1-point Improvement (Decrease) From Baseline on the Allergan Cheek Smoothness Scale (ACSS) on Both Cheeks at Month 1

Time frame: Baseline to Month 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™ n = 71	JUVÉDERM VOLITE™ XC n = 131
Value	4.5 (-0.5 to 9.4)	57.9 (49.3 to 66.6)

Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™ vs JUVÉDERM VOLITE™ XC: Percentage Difference: 53.5 (95% CI 43.5 to 63.5), p <0.001, SAS PROC MIANALYZE

Population analysed: mITT Population included all randomized participants who have baseline assessment on the ACSS scale for both cheeks, and are not in the Fitzpatrick V/VI safety cohort. Missing data in ACSS at Month 1 was imputed using the Multiple Imputation method.

Primary outcome: Number of Participants Who Experience One or More Treatment Emergent Adverse Event (TEAE)

Time frame: From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months). Count of participants. Unit: Participants

Measure	Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™ n = 74	JUVÉDERM VOLITE™ XC n = 135	Treated Period: VOLITE Post-Control Group n = 64	Repeat Treatment Period: JUVÉDERM® VOLITE™ XC n = 79
Value	5	14	14	5

Population analysed: Safety Population included all participants who are randomized and received study intervention (VOLITE or no treatment). A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated in the study. Therefore, this participant was included in the treatment group for the mITT population and in the control group for the safety population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™	0 of 74 (0%)	0 of 74 (0%)	0 of 74
Treated Period: JUVÉDERM® VOLITE™ XC	6 of 135 (4.4%)	2 of 135 (1.5%)	0 of 135
Treated Period: VOLITE Post-Control Group	3 of 64 (4.7%)	4 of 64 (6.3%)	0 of 64
Repeat Treatment Period: JUVÉDERM® VOLITE™ XC	3 of 79 (3.8%)	0 of 79 (0%)	0 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

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

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing JUVÉDERM VOLITE™ XC in people with Skin Smoothness of the Cheeks, run by Allergan at 14 sites in 2 countries.

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 2 inclusion and 17 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 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Puerto Rico. 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 19 Dec 2022). 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 1-point Improvement (Decrease) From Baseline on the Allergan Cheek Smoothness Scale (ACSS) on Both Cheeks at Month 1 (time frame: Baseline to Month 1). 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 NCT03728309.

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 19 Dec 2022.