Deformity of Nasal CartilagePhase 1NCT04169308
Effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty
A Phase 1 study testing Restylane-L® Filler injection in people with Deformity of Nasal Cartilage, run by DeNova Research at 1 site in United States.
Trial summary
The purpose of this research is to determine the effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life determined by using the FACE-Q Scale. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deformity of Nasal Cartilage
- What is being tested?
- Restylane-L® Filler injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 21 Jul 2020
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females of ages 21 and above.
- Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
- Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.
Who cannot join
- Males and females below age of 21.
- Subjects who have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
- Subjects who are pregnant or nursing.
- Subjects with a known allergy or sensitivity to any component of the study ingredients.
- Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
- Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
- Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose, implants, and previous surgical rhinoplasty.
- Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life (FACE-Q Scale)
The purpose of this research is to determine the effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life determined by using the FACE-Q Scale.
Secondary objectives include:
To determine the efficacy of Restylane-L® Filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2D photographs.
To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.
To determine the safety of Restylane-L® Filler injection to the nose for non-surgical rhinoplasty.
- Conditions
- Deformity of Nasal Cartilage
- Being tested
- Restylane-L® Filler injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane-L® Filler injectionDrug
Restylane-L® Filler injection into the soft tissue of the nose
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Restylane-L® Filler injection | Experimental | Not described Receives: Drug: Restylane-L® Filler injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of Restylane-L® Filler injection into the nose on first impressions and quality of life based on the validated questionnaires using FACE-Q scales.
We will measure changes in first impressions using a questionnaire with categories which include social skills, academic performance, dating success, occupational success, attractiveness, financial success, relationship success, and athletic skills. The 300 independent reviewers will grade each photo on a scale of 1(least favorable) to 10 (best). Evaluation of effects on quality of life will be reported through comparison of pre/post injection quality of life survey scores filled out by patients using the validated FACE-Q PRO survey measure (categories include appraisal of nasal appearance, psychological well-being, social function, and psychological distress). Maximal reported score is 4 (very satisfied) and lowest reported score is 1 (very dissatisfied).
Measured: 4 weeks
Secondary outcomes (3)
To determine the efficacy of Restylane-L® Filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2D photographs.
Secondary assessment of this study is to determine the efficacy of Restylane-L® filler injection into the nose as defined by the reduction of the nasal dorsal convexity to 0mm (+/- 10% of pre injection value) as measured by differences in length of a line (from pre to post injection photos) from the highest tip of the nasal dorsum to a line drawn from the Radix to the supratip region on a lateral view 2D photograph. This will be performed through calculation of changes in nasal dorsal hump convexity for all patients. All measures will be performed in triplicate and the mean of the 3 measures will be used.
Measured: 4 weeks
To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.
Subgroup analysis will be performed for the patients who also underwent augmentation of the nasal tip to measure changes in projection (in mm) and rotation (in degrees) achieved from injection of filler. We will be using the Goode method for measuring nasal projection. We will be reporting the following measurements:
Nasal projection is the perpendicular distance between the tip-defining point and a line passing through the nasion and alar crease.
Nasal length is the distance between the nasion and the tip-defining point. The ideal Goode ratio of 0.55 to 0.60 is the perpendicular distance between the tip-defining point and a line passing through the nasion and alar crease divided by nasal length.
Nasal tip rotation or the nasolabial angle (normal 90-120 degrees), is the angle defined by the columellar point-to-subnasale line intersecting with subnasale-to-labrale superius line.
The mean of the 3 measurements in (mm for distance) or (degrees for rotation) will be reported.
Measured: 4 weeks
To determine the safety of Restylane-L® Filler injection to the nose for non-surgical rhinoplasty by recording the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The safety profile of injecting Restylane-L® into the nose will be measured by continually monitoring for AEs during the duration of the study and reporting the total number and description of events.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Jan 2019
- Primary completion20 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deformity of Nasal CartilageStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Steven H. Dayan, University of Illinois Chicago
- Investigators
- Steven Dayan, MD, Principal investigator, DeNova Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169308
- Sponsor's protocol ID
- RRFI-2019
- Status last verified
- Aug 2020
- First submitted
- 12 Nov 2019
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life (FACE-Q Scale)
- ClinicalTrials.gov ID
- NCT04169308
- Acronym / sponsor ID
- RRFI-2019
- Conditions
- Deformity of Nasal Cartilage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 19 Nov 2019 (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.
The purpose of this research is to determine the effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty on First Impressions and Quality of Life determined by using the FACE-Q Scale.
Secondary objectives include:
To determine the efficacy of Restylane-L® Filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2D photographs.
To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.
To determine the safety of Restylane-L® Filler injection to the nose for non-surgical rhinoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Restylane-L® Filler injection | Experimental | Drug: Restylane-L® Filler injection |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females of ages 21 and above.
- Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
- Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.
Key exclusion criteria (8 listed)
- Males and females below age of 21.
- Subjects who have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
- Subjects who are pregnant or nursing.
- Subjects with a known allergy or sensitivity to any component of the study ingredients.
- Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
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-L® Filler injectionRestylane-L® Filler injection into the soft tissue of the nose | Drug | Experimental: Restylane-L® Filler injection |
Primary outcome
To determine the effects of Restylane-L® Filler injection into the nose on first impressions and quality of life based on the validated questionnaires using FACE-Q scales.
Time frame: 4 weeks
We will measure changes in first impressions using a questionnaire with categories which include social skills, academic performance, dating success, occupational success, attractiveness, financial success, relationship success, and athletic skills. The 300 independent reviewers will grade each photo on a scale of 1(least favorable) to 10 (best). Evaluation of effects on quality of life will be reported through comparison of pre/post injection quality of life survey scores filled out by patients using the validated FACE-Q PRO survey measure (categories include appraisal of nasal appearance, psychological well-being, social function, and psychological distress). Maximal reported score is 4 (very satisfied) and lowest reported score is 1 (very dissatisfied).
3 secondary outcomes
To determine the efficacy of Restylane-L® Filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2D photographs.
Time frame: 4 weeks
To measure changes in nasal projection and rotation after injection with Restylane-L® Filler in subset of patients who underwent nasal tip augmentation.
Time frame: 4 weeks
To determine the safety of Restylane-L® Filler injection to the nose for non-surgical rhinoplasty by recording the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 4 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 13 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Steven Dayan, MD principal investigator
DeNova Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Restylane-L® Filler injection in people with Deformity of Nasal Cartilage, run by DeNova Research at 1 site in United States.
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 8 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine the effects of Restylane-L® Filler injection into the nose on first impressions and quality of life based on the validated questionnaires using FACE-Q scales. (time frame: 4 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 13 Aug 2020.