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

NCT ID: NCT03241862

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-06-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Restylane® Silk

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

Group Type: EXPERIMENTAL

Restylane® Silk

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DeNova Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven H Dayan, MD

Role: PRINCIPAL_INVESTIGATOR

DeNova Research

Locations

DeNova Research

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Silk-FI-01

Identifier Type: -

Identifier Source: org_study_id