Evaluate the safety, side effects and maximum tolerable dose of 5 Antimicrobial Peptides on the skin of healthy volunteers to the treatment of Skin and Soft Tissue Infections.

Phase 1

• Conditions: Skin and soft tissue infections.; Infections of the skin and subcutaneous tissue; L00-L08

• Registration Number: IRCT20190924044863N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.