Assessment and Augmentation of Lip Appearance in Specific Study Populations (NCT04839692) | Clinical Trial Compass
CompletedPhase 4
Assessment and Augmentation of Lip Appearance in Specific Study Populations
United States37 participantsStarted 2021-05-07
Plain-language 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.
Who can participate
Age range21 Years
SexFEMALE
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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 re…