Assessment and Augmentation of Lip Appearance in Specific Study Populations

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will investigate aging of the cutaneous changes of human skin anatomy in the lips and perioral area to better understand and quantify the aging process in this, including the effect of age on lip redness. Additionally, the investigators aim to test the effects of a common lip augmentation procedure, hyaluronic-acid based fillers, on the appearance (volume, texture and color) of aging lips, in addition to the tolerability of this procedure. It is hypothesized that dermal lip fillers may decrease the redness of the lips. Besides, the investigators want to evaluate oxytocin level changes and relate it to subjects' satisfaction after the lip filler procedure.

Official Title
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Assessment and Augmentation of Lip Appearance in Specific Study Populations

Conditions
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Lip, Lip Aging, Lip Augmentation

Intervention / Treatment
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* Drug: Hyaluronic acid filler


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Young females (21-30 years old)<br>young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips | Drug: Hyaluronic acid filler<br>* Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.<br>|
| Other: post menopausal females<br>post menopausal females from all phototypes who have thin or moderately thick lips | Drug: Hyaluronic acid filler<br>* Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lip Vessel's Thickness | Pre and post-treatment lip vessel thickness was measured in µm using Optical Coherence Tomography-Angiography imaging. For each age group, pre and post-treatment means were calculated. The difference between the post and the pre-treatment means is shown below (post-treatment mean - pre-treatment mean). | Day 1 and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong-Baker FACES Pain Rating Scale | This scale will be used to record the subject's overall pain from the procedure. There are 6 faces ranging from 0=no pain to 10=the worst pain. | Day 1 | 
| Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure) | The Lip Fullness Grading Scale was used to measure the size of the lips before and after the procedure in both groups. The result presented below is the difference between the means after and before the procedures for each group. min value: 0 - very thin lips - worse outcome Max value: 4 - full lips- a better outcome | D1 and D14 |