Nasolabial FoldNCT07150273
A Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold
A study testing UNIVELO Sub-Q 2mL and Restylane Sub-Q 2mL in people with Nasolabial Fold, run by Jetema Co., Ltd..
Trial summary
A 48-week, single-center, randomized, patient \& evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nasolabial Fold
- What is being tested?
- UNIVELO Sub-Q 2mL and Restylane Sub-Q 2mL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2016to 28 Jul 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who desire temporary improvement of both nasolabial folds and who has rated 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) (the rating does not have to be the same for both sides)
- Subjects who have agreed to discontinue all dermatological treatments or procedures, including those for facial wrinkles improvement in the facial area, during the clinical trial period
- Subjects capable of understanding and complying with directions and who can participation for the full duration of the clinical trial period
- Subjects who have voluntarily decided to participate in the clinical trial and have given written consent by signing the subject informed consent form
Who cannot join
- Subjects who have been administered an antithrombotic agent (with the exception of low dosage aspirin (100mg, maximum 300mg/day)) within 2 weeks of the date of the screening
- Subjects who have had a history of any bleeding disorder, in the past or the present
About this study
Official title: A Randomized, Single-Center, Patient & Evaluator-Blind, Matched Pairs, Active-Controlled Design Confirmatory Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold
A 48-week, single-center, randomized, patient \& evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design
- Conditions
- Nasolabial Fold
- Being tested
- UNIVELO Sub-Q 2mL, Restylane Sub-Q 2mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNIVELO Sub-Q 2mLDevice
Test device
Restylane Sub-Q 2mLDevice
Comparator Device
| Study group | Role | What they receive |
|---|---|---|
| Test Device - UNIVELO Sub-Q | Experimental | UNIVELO Sub-Q Receives: Device: UNIVELO Sub-Q 2mL |
| Comparator Device - Restylane Sub-Q | Active comparator | Restylane Sub-Q Receives: Device: Restylane Sub-Q 2mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle Severity Rating Scale (WSRS)
Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)
Measured: 24 weeks
Secondary outcomes (2)
Wrinkle Severity Rating Scale (WSRS)
Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)
Measured: 8 weeks, 16 weeks, 36 weeks, 48 weeks
Global Aesthetic Improvement Scale (GAIS)
Measure improvement status of wrinkle from score of -1 (worse) to 3 (very much improved)
Measured: 8 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start23 Feb 2016
- Primary completion23 Mar 2017
- Study completion28 Jul 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jetema Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150273
- Sponsor's protocol ID
- PRO_UNI_1506
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 8 Sep 2025
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Center, Patient & Evaluator-Blind, Matched Pairs, Active-Controlled Design Confirmatory Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold
- ClinicalTrials.gov ID
- NCT07150273
- Acronym / sponsor ID
- PRO_UNI_1506
- Conditions
- Nasolabial Fold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Jetema Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 2 Sep 2025 (actual)
- 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.
A 48-week, single-center, randomized, patient \& evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Device - UNIVELO Sub-Q | Experimental | Device: UNIVELO Sub-Q 2mLUNIVELO Sub-Q |
| Comparator Device - Restylane Sub-Q | Active comparator | Device: Restylane Sub-Q 2mLRestylane Sub-Q |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who desire temporary improvement of both nasolabial folds and who has rated 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) (the rating does not have to be the same for both sides)
- Subjects who have agreed to discontinue all dermatological treatments or procedures, including those for facial wrinkles improvement in the facial area, during the clinical trial period
- Subjects capable of understanding and complying with directions and who can participation for the full duration of the clinical trial period
- Subjects who have voluntarily decided to participate in the clinical trial and have given written consent by signing the subject informed consent form
Key exclusion criteria (2 listed)
- Subjects who have been administered an antithrombotic agent (with the exception of low dosage aspirin (100mg, maximum 300mg/day)) within 2 weeks of the date of the screening
- Subjects who have had a history of any bleeding disorder, in the past or the present
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 |
|---|---|---|
| UNIVELO Sub-Q 2mLTest device | Device | Test Device - UNIVELO Sub-Q |
| Restylane Sub-Q 2mLComparator Device | Device | Comparator Device - Restylane Sub-Q |
Primary outcome
Wrinkle Severity Rating Scale (WSRS)
Time frame: 24 weeks
Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds)
2 secondary outcomes
Wrinkle Severity Rating Scale (WSRS)
Time frame: 8 weeks, 16 weeks, 36 weeks, 48 weeks
Global Aesthetic Improvement Scale (GAIS)
Time frame: 8 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks
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 8 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing UNIVELO Sub-Q 2mL and Restylane Sub-Q 2mL in people with Nasolabial Fold, run by Jetema Co., Ltd..
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 4 inclusion and 2 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Wrinkle Severity Rating Scale (WSRS) (time frame: 24 weeks). 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 8 Sep 2025.