Temporary Correction of WrinklesNCT03738007
Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of YVOIRE Volume Versus Perlane in Nasolabial Fold Injection
A study testing HA IDF II and Perlane in people with Temporary Correction of Wrinkles, run by LG Life Sciences.
Trial summary
This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporary Correction of Wrinkles
- What is being tested?
- HA IDF II and Perlane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Dec 2010
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: Women in 30~55 years.
- Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
- Those who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent form.
Who cannot join
- Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
- Those with a history of severe allergy
- Those with hypertrophic scar or a history of kelloid
- Patients with an autoimmune disease
- Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
- Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study
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- Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive materials (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
- Patients with a malignant tumor
- Women in pregnancy or lactation
- Hepatitis carriers or VDRL/HIV positive patients
- Those with a hypersensitivity to the investigational medical device of this study
- Other persons including those considered as difficult to perform this study by the principal investigator
About this study
Official title: A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of HA IDF II Versus Perlane in Nasolabial Fold Injection
This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.
- Conditions
- Temporary Correction of Wrinkles
- Being tested
- HA IDF II, Perlane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA IDF IIDevice
Treatment with HA IDF II (YVOIRE volume)
PerlaneDevice
Treatment with Perlane
| Study group | Role | What they receive |
|---|---|---|
| HA IDF II | Experimental | Not described Receives: Device: HA IDF II |
| Perlane | Active comparator | Not described Receives: Device: Perlane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device.
Wrinkle Severity Rating Scale (WSRS)
- Absent: no visible fold; continuous line
- Mild: Shallow but visible fold with slight indentation; minor facial feature
- Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected.
- Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched
- Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone
Measured: Week 26 (Visit 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporary Correction of 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 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
- NCT03738007
- Sponsor's protocol ID
- LG-HACL009
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of HA IDF II Versus Perlane in Nasolabial Fold Injection
- ClinicalTrials.gov ID
- NCT03738007
- Acronym / sponsor ID
- LG-HACL009
- Conditions
- Temporary Correction of Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2010 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Nov 2018 (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.
This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA IDF II | Experimental | Device: HA IDF II |
| Perlane | Active comparator | Device: Perlane |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: Women in 30~55 years.
- Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
- Those who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent form.
Key exclusion criteria (12 listed)
- Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
- Those with a history of severe allergy
- Those with hypertrophic scar or a history of kelloid
- Patients with an autoimmune disease
- Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
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 IITreatment with HA IDF II (YVOIRE volume) | Device | HA IDF II |
| PerlaneTreatment with Perlane | Device | Perlane |
Primary outcome
Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device.
Time frame: Week 26 (Visit 7)
Wrinkle Severity Rating Scale (WSRS) 1. Absent: no visible fold; continuous line 2. Mild: Shallow but visible fold with slight indentation; minor facial feature 3. Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected. 4. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched 5. Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone
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 26 Nov 2018.
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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 and Perlane in people with Temporary Correction of 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 3 inclusion and 12 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 26 Nov 2018. 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?
Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device. (time frame: Week 26 (Visit 7)). 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 26 Nov 2018.