Assessment and Augmentation of Lip Appearance in Specific Study Populations
Condition: Lip Aging; Lip Augmentation; Lip
Intervention: Hyaluronic acid filler
Intervention description: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Investigators will enroll 40 subjects; 20 subjects who are 21-30 years old and 20 subjects who are post-menopausal women. Both groups will receive identical treatments.
Masking: Single (Investigator)
Masking description: Standard photographs will be blindly reviewed by a physician.
Enrollment: 37.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study aims to learn more about the effects of aging and lip filler treatment on lips and
      the surrounding skin by comparing, among two different age groups of people, changes in the
      blood vessels and nerves, volume, color and texture change before and after lip filler
      treatment and pain tolerance from lip filler treatment.
    

Eligibility criteria:

        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.