BioPlx Skin Study
- Registration Number
- CTRI/2018/08/015391
- Lead Sponsor
- BioPlx Microbiomics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Provision of signed and dated informed consent form.
2) Stated willingness to comply with all study procedures and availability for the duration of the study.
3) Positive Staphylococcus aureus CHROMagar plate from screening nasal swab.
4) Agreement to avoid antibiotic use unless instructed by a physician for the duration of this study.
5) Agreement to avoid antimicrobial soaps and antiseptic applications on the skin for the duration of this study.
1) Current use of oral, intravenous or topical antibiotics.
2) History of autoimmune disease or immunosuppressive conditions or therapy.
3) Active diagnosis of cancer.
4) Active diagnosis of infection.
5) History of diabetes mellitus with HgbA1C > 6.5.
6) Planned pregnancy during the study or current pregnancy.
7) Febrile illness within 1 week of enrollment.
8) Receipt of a live virus vaccine within 2 months prior to enrollment.
9) Treatment with another investigational drug or other intervention within 3 months of enrollment.
10) Chronic skin conditions such as eczema.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence of dermal or mucosal events at 7 days post-application.Timepoint: Cumulative incidence of dermal or mucosal events at 7 days post-application.
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable