Skin and soft tissue infections. Infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention 1: Intervention group: This group will receive the antimicrobial peptides of the present study as a single local dose. The amount of consumption will be with concentrations 1.2 to 4 times
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patient compliance with treatment method (Adherence) Having conditions for frequent visits to control the treatment method Informed consent to participate in the research project Non-smoker (no nicotine products for at least 3 months prior to screening) BMI =18 kg/m2 and =32.0 kg/m2 with a minimum weight of 50 kg
Exclusion criteria
Exclusion criteria: Use of any antibiotic within 7 days before entering the study Use of traditional treatments within 7 days before entering the study Use of immunosuppressive drugs within 14 days before entering the study Having any history of skin allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the safety of topical application of Antimicrobial Peptides (AMPs). Timepoint: The time periods of investigation of the safety of the investigational medicinal product: the results will be evaluated at 30 and 60 minutes after the intervention (to evaluate immediate sensitivity) and at 24 to 72 hours after the intervention (to evaluate delayed sensitivity). Method of measurement: Medical examination of participants and perform clinical and laboratory tests based on the guideline for Safety Monitoring of Clinical Trial.;Calculate the maximum tolerable dose of topical application of Antimicrobial Peptides (AMPs). Timepoint: During the study, it will be variable according to the maximum tolerable dose of peptides. Method of measurement: The maximum tolerable dose of peptides that were safe and have no side effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of adverse effects based on Safety Monitoring Protocol in Clinical Trial. Timepoint: The time periods of investigation of the safety of the investigational medicinal product: the results will be evaluated at 30 and 60 minutes after the intervention (to evaluate immediate sensitivity) and at 24 to 72 hours after the intervention (to evaluate delayed sensitivity). Method of measurement: Estimating the grade of severity (grade 1 to 4) based on Safety Monitoring Protocol in Clinical Trial. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahdi Kouhi
Mashhad University of Medical Sciences
Outcome results
None listed