Trial Outcomes & Findings for Assess the Impact of Lip Rejuvenation on Projected First Impressions and Mood Perceptions (NCT NCT03241862)

Last Updated: 2020-11-04

Results Overview

The projected first impressions are assessed by blinded evaluators using photographs. The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ). Each of the below First Impression Questionnaire (FIQ) categories is scored between 1 (disagree)-10 (agree) and a total of 8 categories (see below) are assessed for a total possible score of 80. All scores will be graded out of a total possible score of 80 points Social skills Academic Performance Dating Success Occupational success Attractiveness Financial Success Relationship success Athletic success Total scores closer to 80 indicate a more favorable outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

1 month

Results posted on

2020-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Restylane® Silk All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk. Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assess the Impact of Lip Rejuvenation on Projected First Impressions and Mood Perceptions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restylane® Silk n=20 Participants All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk. Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	53 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	Restylane® Silk n=20 lips first impressions All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk. Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.
First Impressions Social skills	46.756 score on a scale Standard Deviation 0.052
First Impressions Academic Performance	27.769 score on a scale Standard Deviation 0.887
First Impressions Dating success	46.391 score on a scale Standard Deviation 0.648
First Impressions Occupational success	34.404 score on a scale Standard Deviation 0.555
First Impressions Attractiveness	49.612 score on a scale Standard Deviation 0.544
First Impressions Financial success	25.029 score on a scale Standard Deviation 0.758
First Impressions Relationship success	34.245 score on a scale Standard Deviation 0.931
First Impressions Athletic success	45.433 score on a scale Standard Deviation 0.835

SECONDARY outcome

Timeframe: Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)

Changes in the appearance of the lip and the perioral area are assessed by the PI using the Oral Commissure Severity Scale (OCSS) at Visit 1 and Visit 3/4 Oral Commissure Severity Scale (OCSS): graded from None (0), Mild (1), Moderate (2), Severe (3) None: No wrinkle or fold; slight upturned commissures Mild: Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners Moderate: Moderately deep and/or long wrinkle or crease; downturned corners Severe: Very deep and/or long wrinkle or crease; frown at rest

Outcome measures

Outcome measures
Measure	Restylane® Silk n=20 Participants All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk. Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.
Appearance of the Lip and Perioral Area Visit 1	2.39 units on a scale Standard Deviation 0.502
Appearance of the Lip and Perioral Area Visit 3/4	0.71 units on a scale Standard Deviation 0.470

Adverse Events

Restylane® Silk

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