A phase III, Randomized, Open label, Controlled, Multicentre, Clinical study of the Safety and Efficacy of Toppically Applied Moist Exposed Burn Ointment (MEBO) Compared to Silver Sulphadiazine (SSD) in subjects with Mild thermal burn injuries.

Shantou MEBO Pharmaceutical Co, Ltd.,0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Mild thermal origin burns (Superficial II Degree burns and total burn area for
•all burns on a single patient no greater than 15% of TBSA);
•2. Male or female between 13 and 50 years of age;
•3. Patient or patient?s legally acceptable representative is willing to provide
•voluntary informed consent;
•4. Capable of understanding and willing to comply with study protocol
•requirements;
•5. Agree to stay in hospital for the first 7 days of treatment;
•6. Female of childbearing potential with a negative result from pregnancy test at
•screening who agrees to use an acceptable birth control method (hormonal or
•IUD) or abstinence throughout the trial; and
•7. Subjects infected with MRSA can be included based on the opinion of the
•Investigator.

•1. Subjects with chemical, electrical, and radiation burns;
•2. Pregnant or breast-feeding female;
•3. Known or suspected allergies to any of the components of MEBO;
•4. Subjects who in the opinion of the Investigator are not suitable for inclusion;
•5. Subjects previously on any other topical treatment except SSD;
•6. Any immune deficiency disorder, or known clinically significant organ or
•systemic diseases, such that, in the opinion of the investigator, the significance
•of the disease will compromise the subject?s participation in the study (e.g.,
•severe retinopathy requiring laser therapy, terminal kidney disease etc.); or
•7. Participation in another investigational drug study within 30 days prior to treatment start.

发起方

Shantou MEBO Pharmaceutical Co, Ltd.,