Perioral Rejuvenation and Upper Lip Enhancement

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.

Study Overview

• Status: Completed
• Conditions: Perioral Rejuvenation; Upper Lip Projection
• Intervention / Treatment: Device: Restylane® Defyne

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nasal Tip Projection	Device: Restylane® Defyne; hyaluronic acid filler injection
EXPERIMENTAL: Upper Lip Position	Device: Restylane® Defyne; hyaluronic acid filler injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and 2 months

Collaborators and Investigators

• Sponsor: DeNova Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2017
• Primary Completion (ACTUAL): July 3, 2018
• Study Completion (ACTUAL): July 3, 2018

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (ACTUAL): September 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: REST-DEF-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes