Nasolabial FoldNCT02558283
A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults
A study testing JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in people with Nasolabial Fold, run by Allergan at 5 sites in China.
Trial summary
This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasolabial Fold
- What is being tested?
- JUVÉDERM® VOLIFT® with Lidocaine and Restylane®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 5 sitesChina
- Study dates
- 25 Jan 2016to 19 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Presence of nasolabial folds
- Agree to refrain from treatment with other anti-wrinkle/volumizers below the eye for the duration of the study
Who cannot join
- Ever received semi-permanent fillers or permanent facial implants below the eyes, or plans to receive these treatments during the study
- Undergone temporary dermal filler treatment (eg, hyaluronic acid or collagen) below the eyes within 12 months, or plans to undergo these treatments during the study
- Undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures in the face or neck within 6 months, or plans to undergo these treatments during the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
China Japan Friendship Hospital
Beijing
Peking University Third Hospital
Beijing
General Hospital of Guangzhou Military Command of PLA
Guangzhou
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Guangzhou
Shanghai 9th Hospital
Shanghai
About this study
This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.
- Conditions
- Nasolabial Fold
- Being tested
- JUVÉDERM® VOLIFT® with Lidocaine, Restylane®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM® VOLIFT® with LidocaineDevice
JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.
Restylane®Device
Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.
| Study group | Role | What they receive |
|---|---|---|
| JUVÉDERM® VOLIFT® with Lidocaine - Right Side | Experimental | JUVÉDERM® VOLIFT® with lidocaine injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1. Receives: Device: JUVÉDERM® VOLIFT® with Lidocaine |
| Restylane® - Right Side | Active comparator | Restylane® injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1. Receives: Device: Restylane® |
| JUVÉDERM® VOLIFT® with Lidocaine - Left Side | Experimental | JUVÉDERM® VOLIFT® with lidocaine injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1. Receives: Device: JUVÉDERM® VOLIFT® with Lidocaine |
| Restylane® - Left Side | Active comparator | Restylane® injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1. Receives: Device: Restylane® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS)
Measured: Month 6
Secondary outcomes (3)
Subject's Assessment of Procedural Pain on an 11-Point Scale
Measured: Day 1
Investigator's Assessment of Each NLF on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Measured: Month 6
Subject's Assessment of Each NLF on the 5-Point GAIS
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study start25 Jan 2016
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Jia, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558283
- Sponsor's protocol ID
- VOLIFT-002
- Status last verified
- Aug 2017
- First submitted
- 22 Sep 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults
- ClinicalTrials.gov ID
- NCT02558283
- Acronym / sponsor ID
- VOLIFT-002
- Conditions
- Nasolabial Fold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
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 safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM® VOLIFT® with Lidocaine - Right Side | Experimental | Device: JUVÉDERM® VOLIFT® with LidocaineJUVÉDERM® VOLIFT® with lidocaine injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1. |
| Restylane® - Right Side | Active comparator | Device: Restylane®Restylane® injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1. |
| JUVÉDERM® VOLIFT® with Lidocaine - Left Side | Experimental | Device: JUVÉDERM® VOLIFT® with LidocaineJUVÉDERM® VOLIFT® with lidocaine injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1. |
| Restylane® - Left Side | Active comparator | Device: Restylane®Restylane® injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of nasolabial folds
- Agree to refrain from treatment with other anti-wrinkle/volumizers below the eye for the duration of the study
Key exclusion criteria (3 listed)
- Ever received semi-permanent fillers or permanent facial implants below the eyes, or plans to receive these treatments during the study
- Undergone temporary dermal filler treatment (eg, hyaluronic acid or collagen) below the eyes within 12 months, or plans to undergo these treatments during the study
- Undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures in the face or neck within 6 months, or plans to undergo these treatments during the study
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® VOLIFT® with LidocaineJUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1. | Device | JUVÉDERM® VOLIFT® with Lidocaine - Left Side, JUVÉDERM® VOLIFT® with Lidocaine - Right Side |
| Restylane®Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1. | Device | Restylane® - Left Side, Restylane® - Right Side |
Primary outcome
Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS)
Time frame: Month 6
3 secondary outcomes
Subject's Assessment of Procedural Pain on an 11-Point Scale
Time frame: Day 1
Investigator's Assessment of Each NLF on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 6
Subject's Assessment of Each NLF on the 5-Point GAIS
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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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.
Yi Jia study director
Allergan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in people with Nasolabial Fold, run by Allergan at 5 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 2 inclusion and 3 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS) (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2017.