Comparison of AmnioFix Laser and Standard of Care in Patients Seeking Laser Facial Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time of reepithelialization
研究概览
简要总结
This is a comparison trial with novel application of AmnioFix and a control arm. Patients electively being treated with facial lasers will be assigned to receive AmnioFix in addition to the normal standard of care placed on half of their face after laser procedure, and normal post laser standard of care alone on the other half of their face. The investigators will investigate the end points of healing, recovery time, re-epitheliaziation, and other cosmetic factors. The study is designed to compare AmnioFix to the current standard of laser care.
详细描述
AmnioFix is a dehydrated Human Amnion/ Chorion Membrane (dHACM) allograft and is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. Amniotic membrane is a unique material and its composition contains collagen types I, III, IV, V, and VII. Amniotic membrane is composed of structural extracellular matrix (ECM), that also contains specialized proteins fibronectin, laminins, proteoglycans and glycosaminoglycans. In addition, amniotic membrane contains essential, active, healing growth factors such as epidermal growth factor (EGF), transforming growth factor beta (TGF-b), fibroblast growth factor (FGF), and platelet derived growth factor (PDGF).
The study is designed to compare AmnioFix to the current standard of laser care.
- Patients coming in for fraction or total ablative resurfacing with any methods will be studied
- patients will be assessed prior to any treatment by clinician
- additionally patients will participate in a clinician constructed survey
- patients will be assessed on a rating scale of 1-4 based on erythema, edema/induration, oozing/drainage, and epithelialization
- preoperative photos will be taken of patients
- laser resurfacing will proceed under clinician guidance, and under clinician selected settings
- repeat photographs
- patients will be randomized as to which side of the face receives AmnioFix treatment, and which side receives standard of care
- epifix will be applied appropriatly
- repeat photographs and repeat assessment on 1-4 scale
- patients will follow up at day 1, 4, 7, 14, and 28 +/-3 days to repeat scoring and photography
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patients ages 18-100 seeking laser facial treatment
排除标准
- •patients with treatment areas with active or latent infection
- •patient with a disorder that would create an unacceptable risk of post-operative complications
研究组 & 干预措施
Standard of Care plus AmnioFix
All patients will receive the standard of care alone on half of their face, and AmnioFix in addition to the standard of care on the other half of their face.
干预措施: AmnioFix plus Standard of Care (Device)
Standard of Care plus AmnioFix
All patients will receive the standard of care alone on half of their face, and AmnioFix in addition to the standard of care on the other half of their face.
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Time of reepithelialization
时间窗: 28 days after treatment
Subjects' healing and recovery is the primary outcome measure. Reepithelialization will be assessed at each follow up visit, considering the following: erythema, edema/induration, and oozing/drainage.
次要结局
未报告次要终点