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

• 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.

Primary outcomes

• First Impressions [1 month]: 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.

Secondary outcomes

• Appearance of the Lip and Perioral Area [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

Sex: All, ages: 21 Years to any, accepts healthy volunteers

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.

Participant flow

Outcome results

• First Impressions (Primary), Mean, score on a scale: Restylane® Silk 46.756 +/- 0.052
• Appearance of the Lip and Perioral Area (Secondary), Mean, units on a scale: Restylane® Silk 2.39 +/- 0.502

Adverse events

Time frame: 1 month

• Study Protocol and Statistical Analysis Plan (PDF, 2015-06-11)

• Steven H Dayan, MD, Principal investigator, DeNova Research