NCT03524040已完成不适用
Imaging of Pilosebaceous Units and Acne Lesions by Reflectance Confocal Microscopy and Optical Coherence Tomography
Merete Haedersdal2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年12月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Acne morphology
研究概览
简要总结
The purpose of the study was to investigate if reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) could be used in combination to investigate the morphology of pilosebaceous units and acne lesions in healthy subjects and in acne patients.Furthermore, to investigate contrast effects, biodistribution and selective photothermolysis provided by gold microparticles and diode laser pulses, using RCM, OCT and histology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects
- •Healthy men and women
- •18-45 years of age at baseline
- •Legally competent, able to give verbal and written consent
- •Communicate in Danish verbally as well as in writing
- •Women with negative pregnancy-test
- •Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements.
- •Fitzpatrick skin phototype I-III
- •Subject with previous or prior clinical diagnosis of acne vulgaris, IGA score 1-4
- •Subjects with 1 - 75 inflammatory facial lesions on the cheek, forehead, and/or chin, with no more than 2 nodulocystic lesions (see Appendix II, table 4)
- •Each included patient with acne should represent at least 3 of 5 acne lesions
- •Subject with in good general health, willing to participate and able to give informed consent, and able to comply with protocol requirements
排除标准
- •Pregnant and lactating women
- •Subject with a known allergy to gold, or any other ingredient in the microparticle suspension
- •Individuals with skin diseases or skin lesions in the area of research interest will be excluded
- •Subject with tattoo in the treatment area which may interfere with or confound evaluation of the study
- •Subjects with severe acne (IGA 5) with imminent scarring potential, in the opinion of the investigator
- •Subject with a history of keloids which is deemed clinically relevant in the opinion of the investigator
- •Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or very severe acne requiring the continuation of systemic treatment during the study period.
- •Subject with active skin disease or excessive scarring that, in the opinion of the investigator, would impact the ability to administer the gold microparticles or use of OCT/RCM in the areas
- •Subject having used oral retionoid therapy such as isotretionoin within 3 months prior to baseline.
- •Subject having used topical retinoids, topical corticosteroids, topical antibiotics or combination therapy within 2 weeks of baseline
- •Subject having used over-the-counter topical products containing azelaic acid, benzoyl peroxide, and/or salicylic acid within 1 week of baseline
- •Subject having used light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area within 3 weeks of baseline.
- •Subject who has received an investigational drug or was treated with an investigational device within 30 days prior to baseline.
研究组 & 干预措施
Acne patients
Experimental
Application of gold microparticles to 2-3 facial areas
干预措施: SEB-250 (Device)
Heatlhy volunteers
Experimental
Application of gold microparticles to 2 facial areas
干预措施: SEB-250 (Device)
结局指标
主要结局
Acne morphology
时间窗: 1 year
Qualitative assessment of acne lesions, pilosebaceous units and surrounding skin in RCM and OCT images
Gold microparticle biodistribution
时间窗: 2 years
Evaluation of gold microparticle biodistribution and contrast effects in RCM and OCT images
次要结局
未报告次要终点
研究者
Merete Haedersdal
DMSc, PhD, MD
Bispebjerg Hospital
研究点 (2)
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