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

Assess the Impact of Lip Rejuvenation With Restylane® Silk on Projected First Impressions and Mood Perceptions

20 subjects with mild to severe oral commissures or none to severe perioral lines will be enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days after Optimal Cosmetic Results has been achieved, as judged by the investigator.

Changes in the projected first impression will be assessed by a total of 200 blinded evaluators rating the photographs of subjects from the baseline and from 14 days post achieving the Optimal Cosmetic Results. Changes in subjects' mood will be self-assessed through Subjective Happiness Scale and Happiness Measures questionnaires. Aesthetic alterations will be assessed by the investigator via the Global Aesthetic Improvement Scale, Oral Commissure Severity Scale, and the Perioral Lines Severity Scale as well as by the self-assessment of subjects using the Global Aesthetic Improvement Scale.

Study Overview

• Status: Completed
• Conditions: Lip Rejuvenation
• Intervention / Treatment: Device: Restylane® Silk

• 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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is an adult of at least 21 years of age;
• Subject has mild to severe oral commissures or none to severe perioral lines, as assessed by the treating investigator;
• Subject is willing and able to provide written informed consent prior to the performance of any study related procedure;
• Subject is willing and able to comply with the protocol requirements; and
• Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup

Exclusion Criteria:

• Subjects who have received lip filler treatments in the past 12 months or neurotoxin injections in the past 6 months;
• Subjects who plan to undergo neurotoxin treatments, ablative skin treatments, facial cosmetic surgery, or other injectable filler treatments during the course of the study;
• Subjects with a known allergy or sensitivity to any component of the study ingredients;
• Subjects with a history of bleeding disorders;
• Female subjects who are pregnant or nursing as well as those who are of childbearing potential but do not employ adequate birth control methods;
• Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies;
• Subjects with previous history of sensitivity to amide type local anesthetics;
• Current history of chronic drug or alcohol abuse;
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product;
• Subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment, or unreliability; and
• Enrollment in any active study involving the use of investigational devices or drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restylane® Silk; All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Impressions	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appearance of the Lip and Perioral Area	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	Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)

Collaborators and Investigators

• Sponsor: DeNova Research

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 16, 2017

Study Registration Dates

• First Submitted: September 14, 2015
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Silk-FI-01