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

NCT03241862 | Completed Results

• 1 other identifier: Silk-FI-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lip Rejuvenation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Appearance of the Lip and Perioral Area

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

Study Arms (1)

Restylane® Silk

EXPERIMENTAL

All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.

Device: Restylane® Silk

Interventions

Restylane® Silk DEVICE

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.

Restylane® Silk

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• DeNova Research: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Results Point of Contact

• Title: Steven Dayan, MD
• Organization: DeNova Research

sdayan@drdayan.com

3123352070

Study Officials

• Steven H Dayan, MD

  DeNova Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: August 8, 2017
• Study Start: September 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 16, 2017
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-11

Locations

US (1)