Trial Outcomes & Findings for Perioral Rejuvenation and Upper Lip Enhancement (NCT NCT03273543)

Last Updated: 2020-10-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 2 months

Results posted on

2020-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Nasal Tip Projection Restylane® Defyne: hyaluronic acid filler injection	Upper Lip Position Restylane® Defyne: hyaluronic acid filler injection
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perioral Rejuvenation and Upper Lip Enhancement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nasal Tip Projection n=10 Participants Restylane® Defyne: hyaluronic acid filler injection	Upper Lip Position n=10 Participants Restylane® Defyne: hyaluronic acid filler injection	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.8 years STANDARD_DEVIATION 0 • n=5 Participants	41.2 years STANDARD_DEVIATION 0 • n=7 Participants	39 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 months

Outcome measures

Outcome measures
Measure	Nasal Tip Projection n=10 Participants Restylane® Defyne: hyaluronic acid filler injection Mean nasal tip projection measured by comparing baseline vs post-tx Goode's Ratio
Nasal Tip Projection	0.601 ratio Standard Deviation 0.052

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Nasal Tip Projection n=10 Participants Restylane® Defyne: hyaluronic acid filler injection Mean nasal tip projection measured by comparing baseline vs post-tx Goode's Ratio
Upper Lip Projection	74.245 degrees Standard Deviation 10.859

Adverse Events

Nasal Tip Projection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Upper Lip Position

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Dayan, MD

DeNova Research

Phone: 3123352070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place