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.
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.
Design
Double-blind block randomised, vehicle-controlled, ascending doses clinical trial phase-1with 30 patients in 5 groups. Concealed randomization sequence carried out with sequentially numbered, sealed, opaque envelopes.
Settings and conduct
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 AMPs on their healthy skin and 2 control subjects will receive placebo. The intervention groups will receive 1/2, 1, 2, 3 and 4 fold of the minimum inhibitory concentration (MIC) of peptides, respectively. The duration of treatment will be 21 days with an interval of every 3 days. During the study, safety, side effects and maximum tolerable dose of peptides will be examined.
Participants/Inclusion and exclusion criteria
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
Intervention groups
The intervention groups will be treated with different concentrations of AMPs and the control groups will receive a placebo.
Main outcome variables
1- Evaluate the safety of topical application of Antimicrobial Peptides (AMPs)
2- Calculate the maximum tolerable dose of topical application of Antimicrobial Peptides (AMPs)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190924044863N1
Registration date:2020-06-20, 1399/03/31
Registration timing:prospective
Last update:2020-06-20, 1399/03/31
Update count:1
Registration date
2020-06-20, 1399/03/31
Registrant information
Name
Kiarash Ghazvini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 3239
Email address
ghazvinik@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
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.
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
This study has been designed in phase 1, double-blind, vehicle-controlled, randomized ascending doses trial.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Research Chancellor, Mashhad University of Medical Sciences, In front of Daneshgah No. 18 Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.MUMS.REC.1398.154
2
Ethics committee
Name of ethics committee
Ethics committee of National Institute for Medical Research Development (NIMAD)
Street address
National Institute for Medical Research Development (NIMAD), No.21, At the beginning of Besat Ave.,Western Fatimi Street.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.NIMAD.REC.1398.248
Health conditions studied
1
Description of health condition studied
Skin and soft tissue infections
ICD-10 code
L00-L08
ICD-10 code description
Infections of the skin and subcutaneous tissue
Primary outcomes
1
Description
Evaluate the safety of topical application of Antimicrobial Peptides (AMPs)
Timepoint
At the beginning of the study (before intervention) and 3, 6, 12 and 21 days after the start of intervention
Method of measurement
Medical examination of participants and perform clinical and laboratory tests based on the guideline for Safety Monitoring of Clinical Trial
2
Description
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 outcomes
1
Description
Evaluation of adverse effects based on Safety Monitoring Protocol in Clinical Trial
Timepoint
Continuous evaluation of adverse effects immediately after initiation of the study (Remote monitoring: Daily/Clinical monitoring: Once every three days)
Method of measurement
Estimating the grade of severity (grade 1 to 4) based on Safety Monitoring Protocol in Clinical Trial
Intervention groups
1
Description
Intervention group: This group will be treated with the topical antimicrobial peptides of this study. The duration of usage will take three weeks after the first administration. The frequency of usage will be once every three days at a concentration of about 1/2 to 4 fold of MICs in the form of 5 sequential ascending dose cohorts. The amount of drug should be enough to completely cover at least one square inch of skin. The duration of therapy and frequency of drug/placebo use in the control and intervention groups will be similar.
Category
Treatment - Drugs
2
Description
Control group: This group will be treated with the topical placebo. The duration of usage will take three weeks after the first administration. The frequency of usage will be once every three days. The amount of placebo should be enough to completely cover at least one square inch of skin. The duration of therapy and frequency of drug/placebo use in the control and intervention groups will be similar.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
Mahdi Kouhi
Street address
Qaem Hospital, Ahmadabad Ave., Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3840 0000
Fax
+98 51 3845 3239
Email
Quaem.Medical.Center@mums.ac.ir
Web page address
http://quaem.mums.ac.ir/
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mahdi Kouhi
Street address
Imam Reza Hospital, Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Web page address
http://emamreza.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Research Chancellor, Mashhad University of Medical Sciences, In front of Daneshgah No. 18 Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/index.php
Grant name
Grant of Dr. Kiarash Ghazvini: Project No 971595
Grant code / Reference number
971595
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
National Institute for Medical Research Development (NIMAD)
Proportion provided by this source
90
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Kouhi
Position
Ph.D Student of Medical Bacteriology
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Qaem Hospital, Ahmadabad Ave., Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3845 3239
Fax
+98 51 3845 3239
Email
koohim1@mums.ac.ir
Web page address
https://mail.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kiarash Ghazvini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Qaem Hospital, Ahmadabad Ave., Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3845 3239
Fax
+98 51 3845 3239
Email
ghazvinik@mums.ac.ir
Web page address
https://mail.mums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kiarash Ghazvini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Qaem Hospital, Ahmadabad Ave., Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3845 3239
Fax
+98 51 3845 3239
Email
ghazvinik@mums.ac.ir
Web page address
https://mail.mums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available