Perioral RejuvenationNCT03273543
Perioral Rejuvenation and Upper Lip Enhancement
A study testing Restylane® Defyne in people with Perioral Rejuvenation and Upper Lip Projection, run by DeNova Research at 1 site in United States.
Trial summary
To determine if subjects who receive premaxillary injection demonstrate an increase in nasal tip projection and an associated increase in upper lip projection, and vermillion height. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioral Rejuvenation, Upper Lip Projection
- What is being tested?
- Restylane® Defyne
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 3 Jul 2018
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Subjects Age 21 to 70. 2. Subjects who demonstrate signs of perioral aging or poor upper lip projection.
Who cannot join
- 1. Subjects who plan to undergo peri oral neurotoxin treatments or ablative skin treatments, or have had either of these treatments in the previous 6 months, other injectable filler treatments during the course of the study.
- 2. Subjects who are pregnant or nursing. 3. Subjects with a known allergy or sensitivity to any component of the study ingredients.
- 4. Any history of rhinoplasty or nasal filler injections. 5. Recent history of upper lip augmentation (surgical and non-surgical) within the last 12 months.
- 6. Any history of lip lift or other surgical procedures involving the upper lip.
- 7. Any history of chin augmentation (surgical and non-surgical). 8. Any history of orthognathic surgery. 9. Any history of bleeding disorders (iatrogenic or otherwise). 10. Current history of chronic drug or alcohol abuse. 11. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product (i.e. immunosuppressive therapy).
- 12. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Premaxillary Injection for Perioral Rejuvenation and Upper Lip Enhancement
To determine if subjects who receive premaxillary injection demonstrate an increase in nasal tip projection and an associated increase in upper lip projection, and vermillion height.
- Conditions
- Perioral Rejuvenation, Upper Lip Projection
- Being tested
- Restylane® Defyne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane® DefyneDevice
hyaluronic acid filler injection
| Study group | Role | What they receive |
|---|---|---|
| Nasal Tip Projection | Experimental | Not described Receives: Device: Restylane® Defyne |
| Upper Lip Position | Experimental | Not described Receives: Device: Restylane® Defyne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Tip Projection
Baseline nasal projection measurements will be documented according to Goode's ratio.
The Goode ratio was used as a measurement of tip projection and is defined as the ratio of the nasal height in relation to the nasal length. For each subject's right lateral view photograph, the nasal height was measured as the length of a line drawn from the alar-facial groove to the tip-defining point, and the nasal length was measured as the length of the line drawn from the nasion to the tip-defining point. The nasal height value was then divided by the nasal length value to determine the Goode ratio for a given photograph.
The ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be . 55. If it is more than that the nose is overprojected, if it is under that ratio the nose is underprojected.
Measured: Baseline and 2 months
Upper Lip Projection
baseline upper lip position will recorded by measuring the Z-angle, which is the intersection of the Frankfort horizontal line and the profile line as described by Merrifield. From the straight portrait image, the ratio of the upper lip vermillion height to the lower lip vermillion height will be documented.
Upper lip projection was assessed via measurement of the Z angle. On each subject's right lateral view photograph, a profile line was drawn tangential to the pogonion of the chin and to the most anterior point of the upper lip. A second line was drawn along the Frankfort horizontal plane. The resulting angle at which these two lines intersected corresponded to the Z angle. A decrease in the Z angle to a more acute value on post-treatment photographs would correspond to an increase in upper lip projection.
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start20 Nov 2017
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
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 Perioral RejuvenationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven H. Dayan, DeNova Research
- Investigators
- Steven H Dayan, MD, Principal investigator, DeNova Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273543
- Sponsor's protocol ID
- REST-DEF-2017
- Status last verified
- Sep 2020
- First submitted
- 30 Aug 2017
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premaxillary Injection for Perioral Rejuvenation and Upper Lip Enhancement
- ClinicalTrials.gov ID
- NCT03273543
- Acronym / sponsor ID
- REST-DEF-2017
- Conditions
- Perioral Rejuvenation, Upper Lip Projection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Posted 8 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if subjects who receive premaxillary injection demonstrate an increase in nasal tip projection and an associated increase in upper lip projection, and vermillion height.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Tip Projection | Experimental | Device: Restylane® Defyne |
| Upper Lip Position | Experimental | Device: Restylane® Defyne |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Subjects Age 21 to 70. 2. Subjects who demonstrate signs of perioral aging or poor upper lip projection.
Key exclusion criteria (6 listed)
- 1. Subjects who plan to undergo peri oral neurotoxin treatments or ablative skin treatments, or have had either of these treatments in the previous 6 months, other injectable filler treatments during the course of the study.
- 2. Subjects who are pregnant or nursing. 3. Subjects with a known allergy or sensitivity to any component of the study ingredients.
- 4. Any history of rhinoplasty or nasal filler injections. 5. Recent history of upper lip augmentation (surgical and non-surgical) within the last 12 months.
- 6. Any history of lip lift or other surgical procedures involving the upper lip.
- 7. Any history of chin augmentation (surgical and non-surgical). 8. Any history of orthognathic surgery. 9. Any history of bleeding disorders (iatrogenic or otherwise). 10. Current history of chronic drug or alcohol abuse. 11. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product (i.e. immunosuppressive therapy).
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® Defynehyaluronic acid filler injection | Device | Nasal Tip Projection, Upper Lip Position |
Primary outcome
Nasal Tip Projection
Time frame: Baseline and 2 months
Baseline nasal projection measurements will be documented according to Goode's ratio. The Goode ratio was used as a measurement of tip projection and is defined as the ratio of the nasal height in relation to the nasal length. For each subject's right lateral view photograph, the nasal height was measured as the length of a line drawn from the alar-facial groove to the tip-defining point, and the nasal length was measured as the length of the line drawn from the nasion to the tip-defining point. The nasal height value was then divided by the nasal length value to determine the Goode ratio for a given photograph. The ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be . 55. If it is more than that the nose is overprojected, if it is under that ratio the nose is underprojected.
Upper Lip Projection
Time frame: Baseline and 2 months
baseline upper lip position will recorded by measuring the Z-angle, which is the intersection of the Frankfort horizontal line and the profile line as described by Merrifield. From the straight portrait image, the ratio of the upper lip vermillion height to the lower lip vermillion height will be documented. Upper lip projection was assessed via measurement of the Z angle. On each subject's right lateral view photograph, a profile line was drawn tangential to the pogonion of the chin and to the most anterior point of the upper lip. A second line was drawn along the Frankfort horizontal plane. The resulting angle at which these two lines intersected corresponded to the Z angle. A decrease in the Z angle to a more acute value on post-treatment photographs would correspond to an increase in upper lip projection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 H 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 study testing Restylane® Defyne in people with Perioral Rejuvenation and Upper Lip Projection, 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 1 inclusion and 6 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 8 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 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?
Nasal Tip Projection (time frame: Baseline and 2 months). The study lists 2 primary outcomes in all. 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 8 Oct 2020.