Clinical trial NCT03241862: Assess the Impact of Lip Rejuvenation on Projected First Impressions and Mood Perceptions
Official title: Assess the Impact of Lip Rejuvenation With Restylane® Silk on Projected First Impressions and Mood Perceptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Rejuvenation
Lead sponsor: DeNova Research
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: First Impressions
timeFrame: 1 month
Secondary outcomes:
measure: Appearance of the Lip and Perioral Area
timeFrame: Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research
name: Steven H Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References: