Assessment and Augmentation of Lip Appearance in Specific Study Populations

Inclusion Criteria

• Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
• In good general health, based on answers provided during the screening visit;
• Subjects must be able to read and understand English;
• Caucasian female;
• Aged 21-30 years and post-menopausal;
• Skin Types (all Fitzpatrick Skin Phototypes );
• Smoking history is self-report.
• Have very thin to moderately thick lips (Lip Fullness Grading Scale [LFGS] scores 0-2).

Exclusion Criteria

• Participation in another investigational drug or device clinical trial in the past 30 days;
• Are pregnant or lactating;
• Intake of hormone replacement therapy (HRT) in the past 6 months;
• Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day [e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks];
• Presence of eczema, psoriasis, or any other skin disease on the lips or perioral skin;
• Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest;
• Use of any anti-aging skin care products containing retinoic acid, retinol, or other retinoids (e.g. tazarotene, adapalene) or estrogen on the skin area of interest in the past 6 months;
• Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months;
• Have a history of photodynamic therapy treatment or any skin rejuvenation procedure on the skin area of interest;
• History of blood-clotting abnormality;
• History of keloid formation or hypertrophic scarring;
• Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
• Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study;
• Is not able to follow study protocol;
• Have permanent lip implant, and lip enhancement or laser therapy performed within the preceding 12 months;
• Known history of allergy or sensitivity to glycerol, Tegaderm, lidocaine, hyaluronic acid dermal fillers or materials with gram-positive bacterial proteins.