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IRCT20190924044863N1 IRCT 2020-06-20 Mashhad University of Medical Sciences 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. Evaluate the safety, side effects and maximum tolerable dose of topical application of Antimicrobial Peptides: Pexiganan (MSI-78), Tilapia piscidin 4 (TP4), Melittin, Nisin-A and Omiganan (MX-226) on the skin of healthy volunteers to the treatment of Skin and Soft Tissue Infections. 2020-07-22 anticipated 30 Complete https://irct.ir/trial/47444 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study has been designed in phase 1, double-blind, vehicle-controlled, randomized ascending doses trial, Randomization description: Randomization Method: Block randomization Randomization Unit: Block size of 6 Randomization Tool: Random number table using http://www.randomization.com Random sequence generation: Random number table Allocation concealment: Sequentially numbered, sealed, opaque envelopes, Blinding description: This study is designed as a double-blind. So that the participants, clinicians and evaluators will be unaware of intervention and control groups. In other words, participants, physicians, safety & side effect evaluators and laboratory personnel will not know which participant is taking the drug and which of them is taking the placebo. For this purpose, the drug/placebo will be placed in sequentially numbered, sealed, opaque envelopes and will be assigned to each participant with a random selection. 1 Skin and soft tissue infections. 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 the minimum inhibitory concentrations (MIC) in the form of a single ascending dose in 5 groups. Its consumption amount will be enough to cover at least one square inch of the skin surface. The amount and frequency of drug/placebo consumption will be the same in the control and intervention groups. Intervention 2: Control group: This group will receive a single local dose of placebo. Its consumption amount will be enough to cover at least one square inch of the skin surface. The amount and frequency of drug/placebo consumption will be the same in the control and intervention groups. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Researchers intend to publish all the necessary information, taking into account all the necessary aspects, but the method of publication depends to some extent on the results.
public Mahdi Kouhi
Qaem Hospital, Ahmadabad Ave., Dr. Ali Shariati Square
Mashhad Iran (Islamic Republic of) 9919991766 +98 51 3845 3239 koohim1@mums.ac.ir Mashhad University of Medical Sciences scientific Kiarash Ghazvini
Qaem Hospital, Ahmadabad Ave., Dr. Ali Shariati Square
Mashhad Iran (Islamic Republic of) 9919991766 +98 51 3845 3239 ghazvinik@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 60 years Both 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 L00-L08 Infections of the skin and subcutaneous tissue Treatment - Drugs Placebo 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 the minimum inhibitory concentrations (MIC) in the form of a single ascending dose in 5 groups. Its consumption amount will be enough to cover at least one square inch of the skin surface. The amount and frequency of drug/placebo consumption will be the same in the control and intervention groups. Control group: This group will receive a single local dose of placebo. Its consumption amount will be enough to cover at least one square inch of the skin surface. The amount and frequency of drug/placebo consumption will be the same in the control and intervention groups. 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. 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. National Institute for Medical Research Development (NIMAD) Approved 2019-08-03 Ethics committee of Mashhad University of Medical Sciences Research Chancellor, Mashhad University of Medical Sciences, In front of Daneshgah No. 18 Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of) Approved 2019-06-16 Ethics committee of National Institute for Medical Research Development (NIMAD) National Institute for Medical Research Development (NIMAD), No.21, At the beginning of Besat Ave.,Western Fatimi Street. Tehran Tehran Iran (Islamic Republic of)