NL-OMON50302已完成不适用
Histological and Microbiological Evaluation of Late Occurring Nodules with Hyaluronic Acid Dermal Fillers - Allergan; 0260/0144; CMO-US-FAS-0486
Allergan (North America)0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Have only received HA fillers (no limitation on the brand(s)/product(s) of HA
- •filler used; multiple product use is allowed);
- •Present with an unresolved nodule (inflammatory or non-inflammatory) which
- •was first observed > 4 weeks but < 2 years after the most recent HA filler
- •treatment and is determined to be greater than 3 mm in diameter by palpation;
- •Agree to complete all study required procedures and follow-up; and
- •Provide written informed consent to participate.
- •Have received HA fillers more than once, with the first filler procedure at
- •least two years prior to enrollment;
- •Never developed a nodule;
- •Agree to complete all study required procedures; and
- •Provide written informed consent to participate.
排除标准
- •Have ever received non-HA fillers (e.g. polyacrylamide, calcium
- •hydroxyapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded
- •polytetrafluoroethylene, collagen) including mixes with HA fillers anywhere in
- •Are currently enrolled in a dermal filler clinical trial or previously
- •enrolled in a dermal filler clinical trial with randomized treatment in which
- •the type of dermal filler is unknown (i.e. non-HA filler arm of study);
- •Have a history of keloid or hypertrophic scarring;
- •Are pregnant; and
- •For subjects with a nodule: Have received intralesional intervention for the
- •nodule (e.g. hyaluronidase, corticosteroids, antibiotics, 5-fluorouracil);
研究者
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