Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Change in Baseline PRO and Health Status Perception
研究概览
简要总结
This observational study is designed to evaluate the reported outcomes for patients receiving topical therapy for the treatment of pain, fungal infections or skin scars. The patients will complete the Patient Reported Outcome (PRO) survey monthly and provide valuable data on the patients perception of their health status and well being while receiving therapy.
详细描述
This observational study is designed to evaluate the reported outcomes for patients receiving topical therapy for the treatment of pain, fungal infections or skin scars. The patients will complete the Patient Reported Outcome (PRO) survey monthly and provide valuable data on the patients perception of their health status and well being while receiving therapy.
Patients are enrolled for 18 months. The investigator will complete a global patient assessment monthly of the patient's condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An 18 to 85 years old (inclusive) female or male patient
- •Prescribed compound for the treatment of pain, wound healing or surface skin scar by their Principal Investigator
- •Any systemic disease (cardiac, renal, or hepatic) must be well controlled.
- •Has no skin lesions at the site of application of study medication except for wound under treatment
- •Able to provide informed consent
排除标准
- •Pregnant or lactating females or women at the child bearing potential not using effective contraception.
- •Use of other topical or transdermal medication. Patients may be withdrawn for a period of 2 weeks from all topical or transdermal medications prior to study initiation.
- •Hypersensitivity to local anesthetic or other ingredients of the compounded creams to be used in a study.
- •Prior reconstruction skin surgery or skin grafts in the area of cream application preventing absorption of cream except for the treatment of surface skin scar
- •Chronic pain conditions not expected to respond to topical pain medication such as deep abdominal pain, or from conditions such as cancer, or gouty arthritis.
结局指标
主要结局
Change in Baseline PRO and Health Status Perception
时间窗: Up to eighteen (18) months
次要结局
未报告次要终点