Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Steven Baker
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Reduction in chest lines at rest
研究概览
简要总结
To assess the efficacy of the décoLITE LED system in reducing the signs of skin aging of the décolletage area one week after a six-week treatment course.
详细描述
This was an open-label, single-center trial. Subjects carried out 5 treatments on separate days each week for 6 weeks. The plan for the study was to recruit 25 subjects to consider any dropouts to arrive at a final study total of 20.
Treatments were of 10 minutes duration using a combination of red (630nm) and near infrared (830nm) emitted from light emitting diodes. The device emitted 30mW/cm2 of light, delivering a dose of 18J/cm2 per treatment.
Subjects were assessed at baseline, at 5 weeks, and at 7 weeks (one week after the last treatment).
Assessments included separate evaluations of lines and pigment of the décolletage using the validated scale developed by Landau et al. by the principal investigator and a third party blinded physician, standardized photography, and recording of safety incidents. Subjective responses were based on treatment efficacy and ease of use of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blinded photography- images masked
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female, 30 to 65 years of age.
- •Fitzpatrick phototype I-VI skin.
- •Gave written informed consent.
- •Photoaging of the décolletage area.
- •Agreed NOT to use anti-aging products that contain active ingredients such as retinol and glycolic acid on the treatment area during the study period.
- •Agreed NOT to undergo any aesthetic treatments (such as chemical peels, microdermabrasion, laser surfacing, etc.) in the treatment area during the study period
排除标准
- •Suffering from a systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema, or Albinism.
- •Currently taking (or with a history of taking) medication that is known to induce photosensitivity.
- •Having known malignancy and/or undergoing chemotherapy, radiotherapy, or high doses of corticosteroids.
- •Suffering from keloid scars or birth marks in the treatment area.
- •Suffering from eczema, psoriasis, or skin rashes in the treatment area.
- •Had used an anti-aging product within the 4 weeks prior to commencing the study.
- •Underwent plastic surgery within the last 6 months.
- •Pregnant, breast-feeding, or wishing to become pregnant during the study period.
- •Being enrolled in another clinical trial during the same study period.
- •Having a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrollment into the clinical trial, and which may interfere with the course or outcome of the study.
- •Having medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g., alcoholism or drug abuse).
- •Undergoing or is likely to undergo other treatments of the décolletage area.
结局指标
主要结局
Reduction in chest lines at rest
时间窗: 7 weeks after first treatment intervention
Reduction in chest lines at rest according to the validated Merz aesthetics décolleté grading scale developed by Landau, et al (2016).
次要结局
- Reduction in chest pigmentation(7 weeks after first treatment intervention)