Assessment and Augmentation of Lip Appearance in Specific Study Populations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in Lip Vessel's Thickness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Standard photographs will be blindly reviewed by a physician.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Young females (21-30 years old)
young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
干预措施: Hyaluronic acid filler (Drug)
post menopausal females
post menopausal females from all phototypes who have thin or moderately thick lips
干预措施: Hyaluronic acid filler (Drug)
结局指标
主要结局
Change in Lip Vessel's Thickness
时间窗: Day 1 and Day 14
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).
次要结局
- Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure)(D1 and D14)
- Wong-Baker FACES Pain Rating Scale(Day 1)
研究者
Dieter Manstein, MD
Principal Investigator
Massachusetts General Hospital