Protocol summary
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Study aim
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Evaluate the safety, side effects and maximum tolerable dose of 5 Antimicrobial Peptides (AMPs) on the skin of healthy volunteers to the treatment of Skin and Soft Tissue Infections.
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Design
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Double-blind block randomized, vehicle-controlled, ascending doses clinical trial phase 1with 30 patients in 5 groups. Concealed randomization sequence carried out with sequentially numbered, sealed, opaque envelopes.
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Settings and conduct
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Initially, 30 healthy volunteers who have Inclusion criteria will be randomly divided into five groups of six. In each group, 4 intervention subjects will be treated with the topical single dose AMPs on their healthy skin and 2 control subjects will receive placebo. The intervention groups will receive 1/2, 1, 2, 3 and 4fold of the minimum inhibitory concentration (MIC) of peptides, respectively. During the study, safety, side effects and maximum tolerable dose of peptides will be examined. The place of study is in Imam Reza Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Participant 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 and traditional drugs at least 7 days prior to screening
Use of immunosuppressive drugs at least 14 days prior to screening
Having any history of skin allergies
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Intervention groups
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The intervention groups will be treated with different concentrations of AMPs and the control groups will receive a placebo.
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Main outcome variables
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The safety of local use of antimicrobial peptides,
The maximum tolerable concentration of topical antimicrobial peptides
General information
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Reason for update
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In the section on how to conduct the study, the duration of the treatment was 21 days with an interval of every 3 days.
Considering that the main purpose of the first phase of a clinical trial is to check the safety of the investigational medicinal product in healthy people, not treatment and effectiveness, the subjects of the present study were not sick. Therefore, the duration of treatment is not considered.
For this purpose, the design of a study in the field of measuring the time points of the primary outcome variable in the form of a single ascending dose on the skin of healthy people with the measurement time points at 30 and 60 minutes after the intervention (to assess immediate sensitivity) and at 24 and 72 The hour after the intervention (to assess delayed sensitivity), needs to be updated.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190924044863N1
Registration date:
2020-06-20, 1399/03/31
Registration timing:
prospective
Last update:
2024-01-09, 1402/10/19
Update count:
1
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Registration date
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2020-06-20, 1399/03/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-07-22, 1399/05/01
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Expected recruitment end date
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2021-07-22, 1400/04/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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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.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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This study has been designed in phase 1, double-blind, vehicle-controlled, randomized ascending doses trial.
Ethics committees
1
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Ethics committee
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Approval date
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2019-08-03, 1398/05/12
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Ethics committee reference number
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IR.MUMS.REC.1398.154
2
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Ethics committee
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Approval date
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2019-06-16, 1398/03/26
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Ethics committee reference number
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IR.NIMAD.REC.1398.248
Health conditions studied
1
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Description of health condition studied
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Skin and soft tissue infections
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ICD-10 code
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L00-L08
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ICD-10 code description
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Infections of the skin and subcutaneous tissue
Primary outcomes
1
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Description
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Evaluate the safety of topical application of Antimicrobial Peptides (AMPs)
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Timepoint
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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).
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Method of measurement
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Medical examination of participants and perform clinical and laboratory tests based on the guideline for Safety Monitoring of Clinical Trial
2
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Description
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Calculate the maximum tolerable dose of topical application of Antimicrobial Peptides (AMPs)
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Timepoint
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During the study, it will be variable according to the maximum tolerable dose of peptides.
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Method of measurement
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The maximum tolerable dose of peptides that were safe and have no side effects.
Secondary outcomes
1
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Description
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Evaluation of adverse effects based on Safety Monitoring Protocol in Clinical Trial
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Timepoint
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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).
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Method of measurement
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Estimating the grade of severity (grade 1 to 4) based on Safety Monitoring Protocol in Clinical Trial
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant of Dr. Kiarash Ghazvini: Project No 971595
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Grant code / Reference number
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971595
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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National Institute for Medical Research Development (NIMAD)
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Proportion provided by this source
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90
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable