ISRCTN70155584已完成未知
The role of an over-the-counter topical containing Camellia sinensis in the cosmetic management of skin scars in priming the skin prior to injury
niversity of Manchester0 个研究点目标入组 40 人开始时间: 2020年6月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
2021 results in https://pubmed.ncbi.nlm.nih.gov/33917842/ (added 05/05/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years and older
- •2. Able to fully understand the study requirements and attend all follow-up visits.
- •3. Provide written informed consent to participate in the study.
- •4. Appropriate size and weight - between 40 and 150kg, with a body mass index 20-35 kg/m² (as described in the Quetelet’s index – weight (kg)/height² (m))
排除标准
- •1. Known allergy to any components of the topical formulation
- •2. History or evidence of keloid scarring or fibrotic disorders (self-reported or determined by physical examination)
- •3. Pregnant or are planning to conceive in the next 3 months
- •4. Chronic or active skin disorder considered to adversely affect the scar healing by the investigator
- •5. Any likely healing impairment due to a significant medical condition such as renal, hepatic, haematological, neurological or immune disease, including:
- •5.1. Rheumatoid arthritis
- •5.2. Chronic renal impairment
- •5.3. Diabetes Mellitus
- •5.4. Significant hepatic impairment
- •5.5. Inadequately or uncontrolled congestive heart failure
- •6. Malignancy – diagnosed or treated within the past 5 years
- •7. Immunosuppressive, radiation or chemotherapy within the last three month
- •8. Receiving anticoagulant therapy, systemic steroids, hormone replacement therapy or any investigational drugs, or have taken any in the previous month prior to Day 0
- •9. Evidence of drug abuse
- •10. Have had or are known to have serum hepatitis or are carriers of hepatitis B surface antigen, hepatitis B core antibodies or hepatitis C antibodies. Previous vaccination against hepatitis B and C is not excluded.
- •11. Previously had a positive result to the HIV antibody test, or admit to belonging to a high-risk group.
- •12. Have been involved in other studies in the past two months prior to Day 0 must discuss the exact details of the previous studies prior to a decision being made of eligibility for inclusion in this trial
- •13. Allergic to other amide local anaesthetics
研究者
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