Nasolabial Folds in Chinese PopulationNCT02432742
Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds
A study testing Restylane Perlane and Restylane in people with Nasolabial Folds in Chinese Population, run by Galderma R&D at 3 sites in China.
Trial summary
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasolabial Folds in Chinese Population
- What is being tested?
- Restylane Perlane and Restylane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- May 2015to Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese origin
- Subjects intent to undergo correction of both NLFs with a Wrinkle Severity Rating Scale (WSRS) of 3 on both side or 4 on both side.
- Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period.
- Singed Informed Consent
Who cannot join
- Subjects with traumatic scars or ongoing active skin disease in the area to be treated
- Permanent inplant or filler, including fat injection placed in the area to be treated
- Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion
- Any medical condition in the opinion of the treating investigator who will make the subject unsuitable for inclusion
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Randomised, Multi-center, Evaluator-blinded Study in China to Evaluate the Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population.
- Conditions
- Nasolabial Folds in Chinese Population
- Being tested
- Restylane Perlane, Restylane
- Keywords
- hyaluronic acid, comparative study, NLF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane PerlaneDevice
Intradermal injection
RestylaneDevice
Intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Restylane Perlane | Experimental | Single injection and optional touch up injection with Restylane Perlane in NLF Receives: Device: Restylane Perlane |
| Restylane | Active comparator | Single injection and optional touch up injection with Restylane in NLF Receives: Device: Restylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months
The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionAug 2016
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 Nasolabial Folds in Chinese PopulationStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Q-Med AB, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432742
- Sponsor's protocol ID
- 43CH1408
- Status last verified
- Feb 2021
- First submitted
- 23 Apr 2015
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multi-center, Evaluator-blinded Study in China to Evaluate the Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT02432742
- Acronym / sponsor ID
- 43CH1408
- Conditions
- Nasolabial Folds in Chinese Population
- Keywords
- hyaluronic acid, comparative study, NLF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Posted 23 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Perlane | Experimental | Device: Restylane PerlaneSingle injection and optional touch up injection with Restylane Perlane in NLF |
| Restylane | Active comparator | Device: RestylaneSingle injection and optional touch up injection with Restylane in NLF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese origin
- Subjects intent to undergo correction of both NLFs with a Wrinkle Severity Rating Scale (WSRS) of 3 on both side or 4 on both side.
- Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period.
- Singed Informed Consent
Key exclusion criteria (4 listed)
- Subjects with traumatic scars or ongoing active skin disease in the area to be treated
- Permanent inplant or filler, including fat injection placed in the area to be treated
- Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion
- Any medical condition in the opinion of the treating investigator who will make the subject unsuitable for inclusion
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 |
|---|---|---|
| Restylane PerlaneIntradermal injection | Device | Restylane Perlane |
| RestylaneIntradermal injection | Device | Restylane |
Primary outcome
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months
Time frame: 6 months
The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Q-Med AB study director
Galderma R&D
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Perlane and Restylane in people with Nasolabial Folds in Chinese Population, run by Galderma R&D at 3 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 4 inclusion and 4 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 23 Dec 2020). 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?
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months (time frame: 6 months). 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 Aug 2022.