Nasal AugmentationNCT02216851
Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
A study testing Restylane Perlane in people with Nasal Augmentation, run by Galderma R&D at 2 sites in China.
Trial summary
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Augmentation
- What is being tested?
- Restylane Perlane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2014to Jun 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
- Subject with desire to shape the nasal dorsum and/or nasal root
- Subjects who, in the opinion of the investigator, can achieve a clinically meaningful aesthetic correction of their nose with ≤ 1 ml Restylane Perlane
Who cannot join
- Subjects with previous nasal surgery, including grafts or implants to the nose area
- Subjects requiring filler treatment around the tip of the nose or between the eyebrows (glabella region) to achieve a good aesthetic outcome
- Subjects with a history of chronic sinusitis or rhinitis
- Subjects who have previously received aesthetic treatment in the forehead, glabellar and/or nose area with a dermal filler
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Open Label, No-treatment Controlled, Multi-center, Efficacy and Safety Study Using Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group
- Conditions
- Nasal Augmentation
- Being tested
- Restylane Perlane
- Keywords
- hyaluronic acid, no-treatment control, enhancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane PerlaneDevice
Intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Restylane Perlane | Experimental | Single injection of Restylane Perlane in nasal dorsum and/or nasal root Receives: Device: Restylane Perlane |
| No-treatment control | No intervention | No-treatment control group do not receive any treatment during the main study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control
The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique.
The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group
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 posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionJun 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 Nasal AugmentationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 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
- NCT02216851
- Sponsor's protocol ID
- 43CH1310
- Status last verified
- Sep 2021
- First submitted
- 13 Aug 2014
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 Randomized, Open Label, No-treatment Controlled, Multi-center, Efficacy and Safety Study Using Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
- ClinicalTrials.gov ID
- NCT02216851
- Acronym / sponsor ID
- 43CH1310
- Conditions
- Nasal Augmentation
- Keywords
- hyaluronic acid, no-treatment control, enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Posted 23 Sep 2021
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 to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Perlane | Experimental | Device: Restylane PerlaneSingle injection of Restylane Perlane in nasal dorsum and/or nasal root |
| No-treatment control | No intervention | –No-treatment control group do not receive any treatment during the main study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese origin
- Subject with desire to shape the nasal dorsum and/or nasal root
- Subjects who, in the opinion of the investigator, can achieve a clinically meaningful aesthetic correction of their nose with ≤ 1 ml Restylane Perlane
Key exclusion criteria (4 listed)
- Subjects with previous nasal surgery, including grafts or implants to the nose area
- Subjects requiring filler treatment around the tip of the nose or between the eyebrows (glabella region) to achieve a good aesthetic outcome
- Subjects with a history of chronic sinusitis or rhinitis
- Subjects who have previously received aesthetic treatment in the forehead, glabellar and/or nose area with a dermal filler
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 |
Primary outcome
Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control
Time frame: 6 months
The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group
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.
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
2 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 in people with Nasal Augmentation, run by Galderma R&D at 2 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 3 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 2 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 Sep 2021). 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 Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control (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.