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Evaluation of the safety and Effectiveness of the antimicrobial peptide Pexiganan on infected skin

Clinical trial (phase II) evaluating the safety and therapeutic Effectiveness of antimicrobial peptide Pexiganan (MSI-78), Tilapia piscidin 4 (TP4), Melittin, Nisin-A and Omiganan (MX-226) on skin and soft tissue infections

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190924044863N3
Enrollment
30
Registered
2025-05-07
Start date
2025-07-19
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections of the skin and subcutaneous tissue. Cutaneous abscess, furuncle and carbuncle

Interventions

Intervention 1: "Intervention group 1: received 0.5 times the minimal inhibitory concentration of antimicrobial peptides nisin, melittin, pexiganan, tilapia pisidin, and omiganan (Produced at Mashhad

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Having at least one type of wound or skin infection Participant compliance with treatment method Having conditions for frequent visits to control the treatment method BMI =18 kg/m2 and =32.0 kg/m2 with a minimum weight of 50 kg Age range between 18-65 years Informed consent to participate in the research project Non-smoker (no nicotine products for at least 3 months prior to screening)

Exclusion criteria

Exclusion criteria: People with immunodeficiency and use of immunosuppressive drugs within 14 days prior to study entry Patients who used systemic antibiotics or topical antibiotics for the study wound within 72 hours prior to study entry Pregnant and breastfeeding people Having any history of severe skin allergies

Design outcomes

Primary

MeasureTime frame
Maximum tolerated dose. Timepoint: Per visit (day 3, 10 and 14 during intervention and day 21 (7 days after the intervention is completed). Method of measurement: Visual observation Local Skin Reactions (LSR) and Patient-Reported Outcomes (PROs).

Secondary

MeasureTime frame
Skin Infection Rating Scale (SIRS) Score. Timepoint: At the beginning of the study and at each visit (Day 1, 3 and 10 and 14 during intervention and day 21 (7 days after completing the study)). Method of measurement: Skin Infection Rating Scale (SIRS) and Microbiological examinations of wounds or infected tissue (culture, species determination, and resistance pattern determination).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Khosravi

Mashhad University of Medical Sciences

elhamkhelham71@gmail.com+98 51 3845 3239

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026