N/A
N=20
Perioral Rejuvenation and Upper Lip Enhancement
Perioral Rejuvenation · Upper Lip Projection
Bottom Line
View on ClinicalTrials.gov: NCT03273543 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Nasal Tip Projection — 0.601 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane® Defyne (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- DeNova Research
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nasal Tip Projection |
0.601 | — |
| PRIMARY Upper Lip Projection |
74.245 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 1. Subjects Age 21 to 70. 2. Subjects who demonstrate signs of perioral aging or poor upper lip projection.
Exclusion Criteria
- 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.
- Subjects who are pregnant or nursing. 3. Subjects with a known allergy or sensitivity to any component of the study ingredients.
- Any history of rhinoplasty or nasal filler injections. 5. Recent history of upper lip augmentation (surgical and non-surgical) within the last 12 months.
- Any history of lip lift or other surgical procedures involving the upper lip.
- 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).
- Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
Data sourced from ClinicalTrials.gov (NCT03273543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.