WrinklesNCT02340078
A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Volume Plus Versus YVOIRE Volume in Nasolabial Fold Injection
A study testing HA IDF II plus and HA IDF II in people with Wrinkles, run by LG Life Sciences.
Trial summary
The objective of this study was to evaluate the efficacy and safety of HA IDF II plus (with lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine). Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Wrinkles
- What is being tested?
- HA IDF II plus and HA IDF II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Feb 2015
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 30 and 60
- Those whose wrinkles in the treatment area (nasolabial fold) correspond to Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
- Those who were informed on the purpose, method, and effect etc. of this study and signed the informed consent form
- Those who fell under any of the following 3 cases:
- Surgically sterile women
- Women in menopause over 2 years from the last menstruation, aged at least 45
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- Among the women meeting neither of a nor b, those who agreed to use at least 2 contraception methods specified below (one of the barrier methods must be included) until 14 days after the last treatment with the investigational device
- Barrier methods: Condom, diaphragm, cervical cap (pessary), spermicide
- Hormonal methods: Pills, injection (depot), skin patch, hormonal implant (Implanon), vaginal ring
- Intrauterine devices (IUDs): Cooper IUD (Loop), hormonal IUD (Mirena)
- Natural methods: Basic body temperature, ovulation period, coitus interruptus, abstinent
Who cannot join
- Those with a skin disease (skin infection, eczema, psoriasis, rosacea, herpes etc.) in the lower 2/3 part of the face in which the wrinkle evaluation may be affected
- Patients with a malignant tumor recognized medically important and considered as potentially affecting the clinical study
- Women in pregnancy or lactation
- Those with the bilirubin level exceeding 1.5 times of the upper limit of normal or the ALT/AST level exceeding 2.5 times of the upper limit of normal
- Those with the confirmed infection of syphilis or HIV
- Those who had an anticoagulant therapy or antiplatelet therapy within 2 weeks prior to Visit 1 (screening)
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- Those who used a topical preparation (steroid, retinoid) in the facial area within 4 weeks prior to Visit 2 (randomization )
- Those who experienced a deep chemical peeling or a procedure judged as potentially affecting the clinical study within 3 months prior to Visit 2 (randomization)
- Those who experienced a non-permanent filler procedure or a cosmetic surgery in the face within 9 months prior to Visit 2 (randomization)
- Those who had an implantation procedure with a permanent substance (silicone, PAAG, PMMA, CaHA etc.) in the treatment area (nasolabial fold )
- Those currently with a streptococcal disease
- Those with a history of severe allergy or hypersensitivity (anaphylaxis) judged as potentially affecting the clinical study
- Those with a history of hypertrophic scar or keloid
- Those with a history of bleeding disorder
- Those with a hypersensitivity to the investigational device of this clinical study or lidocaine
- Those who refused to agree not to use a local or systemic pain-relieving agent or other pain-relieving method (e.g.: ice pack) from the midnight of the treatment day with the investigational device through the post-measurement of the last VAS pain scale
- Those who had participated in another clinical study within 1 month prior to Visit 1 (screening)
- Those judged by the investigator as ineligible for this clinical study
About this study
Official title: A Randomized, Multi Center, Double-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Efficacy and Safety of HA IDF II Plus Versus HA IDF II in Nasolabial Fold Injection
The objective of this study was to evaluate the efficacy and safety of HA IDF II plus (with lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine).
- Conditions
- Wrinkles
- Being tested
- HA IDF II plus, HA IDF II
- Keywords
- the facial nasolabial fold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA IDF II plusDevice
HA IDF IIDevice
| Study group | Role | What they receive |
|---|---|---|
| HA IDF II | Active comparator | cross-linked HA filler Receives: Device: HA IDF II |
| HA IDF II plus | Experimental | cross-linked HA filler with lidocaine Receives: Device: HA IDF II plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Device - VAS of the Test Device) Immediately After Treatment With the Investigational Devices
The degree of pain was evaluated by VAS (Visual Analog Scale), measuring the length from the left and to the mark by the subject in millimeter (mm) unit.
Measured: Visit 2 (week 0, immediately after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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 WrinklesStudies 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
- Model description
- Split-face design. Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340078
- Sponsor's protocol ID
- LG-HACL011
- Status last verified
- Nov 2013
- First submitted
- 13 Jan 2015
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi Center, Double-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Efficacy and Safety of HA IDF II Plus Versus HA IDF II in Nasolabial Fold Injection
- ClinicalTrials.gov ID
- NCT02340078
- Acronym / sponsor ID
- LG-HACL011
- Conditions
- Wrinkles
- Keywords
- the facial nasolabial fold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to evaluate the efficacy and safety of HA IDF II plus (with lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-face design. Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization.
| Arm | Type | Receives |
|---|---|---|
| HA IDF II | Active comparator | Device: HA IDF IIcross-linked HA filler |
| HA IDF II plus | Experimental | Device: HA IDF II pluscross-linked HA filler with lidocaine |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Women aged between 30 and 60
- Those whose wrinkles in the treatment area (nasolabial fold) correspond to Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
- Those who were informed on the purpose, method, and effect etc. of this study and signed the informed consent form
- Those who fell under any of the following 3 cases:
Key exclusion criteria (18 listed)
- Those with a skin disease (skin infection, eczema, psoriasis, rosacea, herpes etc.) in the lower 2/3 part of the face in which the wrinkle evaluation may be affected
- Patients with a malignant tumor recognized medically important and considered as potentially affecting the clinical study
- Women in pregnancy or lactation
- Those with the bilirubin level exceeding 1.5 times of the upper limit of normal or the ALT/AST level exceeding 2.5 times of the upper limit of normal
- Those with the confirmed infection of syphilis or HIV
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 |
|---|---|---|
| HA IDF II plus | Device | HA IDF II plus |
| HA IDF II | Device | HA IDF II |
Primary outcome
Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Device - VAS of the Test Device) Immediately After Treatment With the Investigational Devices
Time frame: Visit 2 (week 0, immediately after treatment)
The degree of pain was evaluated by VAS (Visual Analog Scale), measuring the length from the left and to the mark by the subject in millimeter (mm) unit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 HA IDF II plus and HA IDF II in people with Wrinkles, run by LG Life Sciences.
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 11 inclusion and 18 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 23 Jan 2019. 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?
Yes. Results are posted in the registry (first posted 23 Jan 2019). 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?
Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Device - VAS of the Test Device) Immediately After Treatment With the Investigational Devices (time frame: Visit 2 (week 0, immediately after treatment)). 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 23 Jan 2019.