NCT03767400已完成不适用
Dynamic Optical Coherence Tomography (D-OCT) Aging Study: A Preliminary Evaluation of Structural Differences Between Young and Aged Skin, Cellulite and Atrophic Acne Scars in Female Caucasian Subjects With Fitzpatrick Skin Types I-III Utilizing Non-invasive in Vivo D-OCT.
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
- 99
- 试验地点
- 1
- 主要终点
- VivoSight software measurements of Epidermal Thickness
研究概览
简要总结
This single-center clinical study is being conducted over the course of 2 weeks to conduct an exploratory pilot study as a preliminary evaluation of D-OCT's ability to measure skin changes from aging. Assess structural differences between young and aged skin on the face. To identify the structural characteristics of atrophic acne scars relative to normal skin on the face. To explore characteristics of cellulite relative to normal skin on the thigh in young and aged skin.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Caucasian subjects with Fitzpatrick skin types I-III that meet one of the criteria listed below:
- •Ages 18-30 years old without acne scars on the face with or without visible cellulite on posterior thigh, or
- •Ages 55-75 years old without acne scars on the face with or without visible cellulite on posterior thigh, or
- •Ages 18-75 years old with atrophic acne scars
- •Subject has completed an appropriately administered informed consent process which includes signing the IRB approved consent form.
- •Good general health and free of any disease state or physical condition (e.g. psoriasis, rosacea, scars, tattoos etc.) which, in the investigator's opinion, might impair evaluations of the test sites or expose the subject to an unacceptable risk by study participation.
- •Willingness to remove all makeup on the day of the visit. Makeup may be applied after the study visit has been completed.
- •Willingness to cleanse their face and remove all face makeup at each scheduled clinic visit. No other topical products should be applied to the face until the study visit has been completed.
- •i. For cellulite subgroup, willingness to have thigh cleansed at each scheduled clinic visit.
- •Willingness to have investigator exams, skin instrumentation measurements, and digital photos performed on the face and/or thigh (for cellulite subgroup).
- •Women of childbearing potential must not be pregnant at the time of the study.
排除标准
- •Has any condition that, in the opinion of the investigator, would make it unsafe for the subject to participate in the study or interfere with their clinical assessments (including conditions that require the concurrent use of anticoagulants, bleeding coagulopathies, photosensitivity diseases).
- •Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, tattoos, or other skin conditions in the test areas that would interfere with the assessments of this study.
- •Individuals who are pregnant.
- •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 routinely used any of the following topical products, prescription products, or had any of the listed treatments/procedures within the listed time frame prior to study entry or will use during study:
- •Any product that the investigator deems that could affect the study objectives. These include products that address skin imperfections. This does not include a basic cleanser, moisturizer and sunscreen.(time frame 2 weeks)
- •Chemical peel, microdermabrasion, dermaplaning, or microneedling (time frame 3 months)
- •Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, Avage® or Differin® or other similar prescription drugs (time frame 3 months)
- •Cosmetic injections (filler and/or toxins, i.e. Juvederm, Radiesse, Botox, etc.), non-ablative laser or fractional laser resurfacing (time frame 12 months)
- •Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical) (time frame 12 months)
- •Individuals who have any planned surgeries or procedures during the study.
- •Individuals who participated in a facial usage study within the last 30 days, or who are currently participating on another usage study.
- •Individuals currently on or planning to participate on any type of research study at another facility or a doctor's office during this study.
结局指标
主要结局
VivoSight software measurements of Epidermal Thickness
时间窗: Day 1
Epidermal thickness will be measured in microns.
VivoSight software measurements of surface roughness
时间窗: Day 1
Surface roughness measurements (Ra, Rq, Rz) will be measured in microns.
VivoSight software measurements of redness
时间窗: Day 1
Redness will be measured in percent
VivoSight software measurements of attenuation coefficient
时间窗: Day 1
Attenuation coefficient will be measured in AU (arbitrary unit)
次要结局
- Overall Appearance of Fine Lines/Wrinkles Cheek Areas(Day 1)
- Blinded Independent Physician Assessor Grading of the D-OCT Images of Dermoepidermal Contrast(Day 1)
- Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Epidermis(Day 1)
- Overall Photodamage Score at Day 1(Day 1)
- Post-study D-OCT Image Analysis of Collagen Fibers(Day 1)
- Post-study D-OCT Image Analysis of Integrity of Collagen(Day 1)
- Post-study D-OCT Image Analysis of Score of Vessels(Day 1)
- Post-study D-OCT Image Analysis of Vascularity Quantification with Thresholds(Day 1)
- Blinded Independent Physician Assessor Grading of the D-OCT Images of Stratum Corneum Reflectivity(Day 1)
- Blinded Independent Physician Assessor Grading of the D-OCT images of Upper Dermal Reflectivity(Day 1)
- Post-study Dynamic Optical Coherence Tomography (D-OCT) Image Analysis of Epidermal Thickness(Day 1)
- Post-study D-OCT Image Analysis of Density and Attenuation Coefficient of Superficial Dermis(Day 1)
- Blinded Independent Physician Assessor Grading of the D-OCT images of Vessel Density(Day 1)
- Antera 3D Images(Day 1)
- VISIA-CR Images(Day 1)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
OCT and Scaffold Embedding After NC BalloonCoronary Artery DiseaseNCT03106961St. Francis Hospital, New York50
已完成
不适用
Optical Coherence Tomography (OCT) Data Collection StudyNo Eye DiseaseNCT01459731Optovue400
终止
不适用
Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)GlaucomaNCT02785029Heidelberg Engineering GmbH234
终止
不适用
Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-3)GlaucomaNCT02785042Heidelberg Engineering GmbH224
已完成
不适用
Age-dependency of Cornea Biomechanics Using OCT VibrographyCorneaNCT03230981Massachusetts General Hospital46