NCT03400202已完成不适用
Eye Dark Circles: Physiopathologic Aspects and Influence on Quality of Life in Subjects of Various Ethnicities and Fitzpatrick Skin Types Utilizing Non-invasive In Vivo Instrumentation and Validated Questionnaires
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Dark Circles Severity Scale Score
研究概览
简要总结
This study will evaluate the physiopathologic characteristics of dark circles in participants with various ethnicities and Fitzpatrick Skin Types and the impact of the dark circles on the quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with Fitzpatrick skin type I-VI
- •Willingness to not wear any eye makeup on the day of the study visit prior to the study visit appointment
- •Willingness to cleanse the face and remove all makeup at least 15 minutes prior to each scheduled clinic visit
- •Willingness to have facial exams, skin instrumentation measurements, and digital photos performed on the face.
排除标准
- •Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test area
- •Uncontrolled disease such as diabetes, hypertension, hyper or hypo-thyroidism, active hepatitis, immune deficiency, or autoimmune
- •Individuals who have a pre-existing or dormant dermatologic condition (e.g. history of severe psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)
- •Individuals who have had a blepharoplasty procedure or any other surgery in proximity or affecting the test area
- •Individuals with recent procedures/surgeries (less than 6 months) on the eye bulb
- •Individuals with permanent makeup around the eye area
- •Chemical peel, microdermabrasion, microneedling, or dermaplaning in the previous 4 weeks
- •Latisse, Revitalash, or other lash enhancement stimulators in the previous 1 month
- •Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, Avage® or Differin® or other similar prescription drugs within the previous 3 months
- •Cosmetic injections (filler and/or toxins, i.e.Juvederm, Radiesse, Botox, etc.), non- ablative laser or fractional laser resurfacing in the previous 12 months
- •Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical) in the previous 12 months
- •Individuals who have any planned surgeries or procedures during the study.
结局指标
主要结局
Dark Circles Severity Scale Score
时间窗: Day 1
The investigator will access the participant's lower and upper eyelids using the Dark Circles Severity Scale where 0=None to 9=Severe (very dark circles).
Classification Type of Dark Circles Score
时间窗: Day 1
The investigator will assess the lower eyelids for the following types of dark circles: Pigmented, Vascular and Shadow Effect. Each of these 3 types are graded where 0=none to 3=severe.
次要结局
- Subject Questionnaire on Dark Circles, Medical History, and Lifestyle Habits(Day 1)
研究者
研究点 (1)
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