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 range

21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Lip Vessel's Thickness

Timeframe: Day 1 and Day 14

Trial details

NCT IDNCT04839692

SponsorDieter Manstein, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

Results submitted2023-04-21

View on ClinicalTrials.gov More Lip Aging trials