SAFETY AND EFFICACY OF TOPICALLY APPLIED MOIST EXPOSED BURN OINTMENT (MEBO) COMPARED TO SILVER SULPHADIAZINE (SSD)PHASE-III CLINICAL STUDY PROTOCO
- Registration Number
- CTRI/2010/091/000189
- Lead Sponsor
- Shantou MEBO Pharmaceutical Co, Ltd.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method