History
# Registration date Revision Id
2 2023-12-22, 1402/10/01 291224
1 2020-06-20, 1399/03/31 139766
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  • Protocol summary

    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.
    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.
    کارآزمایی بالینی فاز-1 به روش تک دوز صعودی، دارای گروه کنترل، دو سویه کور ، تصادفی شده به روش بلوک بندی شده با استفاده از پاکت های سربسته، با حجم نمونه 30 بیمار در پنج گروه
    کارآزمایی بالینی فاز 1 به روش تک دوز صعودی، دارای گروه کنترل، دو سویه کور ، تصادفی شده به روش بلوک بندی شده با استفاده از پاکت های سربسته، با حجم نمونه 30 بیمار در پنج گروه
    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.
    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.
    ابتدا 30 نفر از داوطلبین سالم دارای شرایط ورود به مطالعه، به طور تصادفی به پنج گروه 6 تایی (2 نفر کنترل و 4 نفر مداخله) تقسیم خواهند شد. در هر گروه به صورت دو سویه کور 4 نفر پپتیدهای ضدمیکروبی و 2 نفر دارونما را به صورت موضعی بر روی پوست سالم خود دریافت خواهند کرد. گروه های مداخله پنج گانه به ترتیب غلظت های 1/2، 1، 2، 3 و 4 برابر حداقل غلظت مهاری (MIC) پپتیدها را دریافت خواهند کرد. طول مدت درمان 21 روز با فاصله هر 3 روز یکبار خواهد بود. در حین مطالعه ایمنی، اثرات جانبی و حداکثر دوز قابل تحمل پپتیدها بررسی خواهند شد.
    ابتدا 30 نفر از داوطلبین سالم دارای شرایط ورود به مطالعه، به طور تصادفی به پنج گروه 6 تایی (2 نفر کنترل و 4 نفر مداخله) تقسیم خواهند شد. در هر گروه به صورت دو سویه کور 4 نفر پپتیدهای ضدمیکروبی و 2 نفر دارونما را به صورت تک دوز موضعی بر روی پوست سالم خود دریافت خواهند کرد. گروه های مداخله پنج گانه به ترتیب غلظت های 1/2، 1، 2، 3 و 4 برابر حداقل غلظت مهاری (MIC) پپتیدها را دریافت خواهند کرد. در حین مطالعه ایمنی، اثرات جانبی و حداکثر دوز قابل تحمل پپتیدها بررسی خواهند شد. محل انجام مطالعه در بیمارستان امام رضا (ع) می باشد
    1- Evaluate the safety of topical application of Antimicrobial Peptides (AMPs) 2- Calculate the maximum tolerable dose of topical application of Antimicrobial Peptides (AMPs)
    The safety of local use of antimicrobial peptides, The maximum tolerable concentration of topical antimicrobial peptides
    1- بررسی ایمنی مصرف موضعی پپتیدهای ضدمیکروبی 2- تعیین حداکثر غلظت قابل تحمل مصرف موضعی پپتیدهای ضدمیکروبی
    ایمنی مصرف موضعی پپتیدهای ضدمیکروبی، حداکثر غلظت قابل تحمل مصرف موضعی پپتیدهای ضدمیکروبی
  • General information

    empty
    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.
    empty
    در بخش نحوه انجام مطالعه، طول مدت درمان 21 روز با فاصله هر 3 روز یکبار ذکر شده بود. با توجه به اینکه هدف عمده فاز یک کار آزمایی بالینی ، بررسی ایمنی محصول دارویی تحقیقاتی در افراد سالم است، نه درمان و اثر بخشی، آزمودنی های مطالعه حاضر بیمار نبوده بنابراین طول مدت درمان مدنظر نمیباشد، بدین منظور طراحی مطالعه در فیلد مقاطع زمانی اندازه گیری متغیر پیامد اولیه به صورت تک دوز صعودی روی پوست سالم افراد با مقاطع زمانی اندازه گیری در زمان های 30 و 60 دقیقه بعد از مداخله (جهت ارزیابی حساسیت فوری) و در زمان های 24 و 72 ساعت بعد از مداخله (جهت ارزیابی حساسیت تاخیری)، نیاز به بروز رسانی دارد.
  • Primary outcomes

    #1
    At the beginning of the study (before intervention) and 3, 6, 12 and 21 days after the start of intervention
    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).
    ابتدای مطالعه (قبل از شروع مداخله) و 3، 6، 12 و 21 روز پس از شروع مداخله
    مقاطع زمانی بررسی ایمنی محصول دارویی تحقیقاتی: پیامدها در زمان های 30 و 60 دقیقه بعد از مداخله (جهت ارزیابی حساسیت فوری) و در زمان های 24 تا 72 ساعت بعد از مداخله (جهت ارزیابی حساسیت تاخیری) ارزیابی خواهند شد.
    #2
    During the study, It will be variable according to the maximum tolerable dose of peptides
    During the study, it will be variable according to the maximum tolerable dose of peptides.
  • Secondary outcomes

    #1
    Continuous evaluation of adverse effects immediately after initiation of the study (Remote monitoring: Daily/Clinical monitoring: Once every three days)
    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).
    بررسی مستمر بروز عوارض ناخواسته بلافاصله پس از شروع مطالعه (غیر حضوری: روزانه، حضوری: هر 3 روز یکبار)
    مقاطع زمانی بررسی ایمنی محصول دارویی تحقیقاتی: پیامدها در زمان های 30 و 60 دقیقه بعد از مداخله (جهت ارزیابی حساسیت فوری) و در زمان های 24 تا 72 ساعت بعد از مداخله (جهت ارزیابی حساسیت تاخیری) ارزیابی خواهند شد.
  • Intervention groups

    #1
    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.
    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.
    گروه مداخله: این گروه پپتیدهای ضدمیکروبی مطالعه حاضر را به صورت موضعی دريافت خواهند کرد. طول مدت مصرف دارو سه هفته بعد از اولین تجویز خواهد بود. تعداد دفعات مصرف هر سه روز یکبار با غلظت های 1/2 تا 4 برابر حداقل غلظت های مهاری (MIC) به صورت تک دوز صعودی در 5 گروه خواهد بود. مقدار مصرف آن به اندازه ای خواهد بود که حداقل یک اینچ مربع از سطح پوست را بپوشاند. طول مدت مصرف و دفعات مصرف دارو/دارونما در گروه های کنترل و مداخله یکسان خواهد بود.
    گروه مداخله: این گروه پپتیدهای ضد میکروبی مطالعه حاضر را به صورت تک دوز موضعی دريافت خواهند کرد. میزان مصرف با غلظت های 1/2 تا 4 برابر حداقل غلظت های مهاری (MIC) به صورت تک دوز صعودی در 5 گروه خواهد بود. مقدار مصرف آن به اندازه ای خواهد بود که حداقل یک اینچ مربع از سطح پوست را بپوشاند. میزان و دفعات مصرف دارو/دارونما در گروه های کنترل و مداخله یکسان خواهد بود.
    #2
    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.
    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.
    گروه کنترل: این گروه دارونما را به صورت موضعی دريافت خواهند کرد. طول مدت مصرف موضعی دارو سه هفته بعد از اولین تجویز خواهد بود. تعداد دفعات مصرف هر سه روز یکبار خواهد بود. مقدار مصرف آن به اندازه ای خواهد بود که حداقل یک اینچ مربع از سطح پوست را بپوشاند. طول مدت درمان و دفعات مصرف دارو/دارونما در گروه های کنترل و مداخله یکسان خواهد بود.
    گروه کنترل: این گروه دارونما را به صورت تک دوز موضعی دريافت خواهند کرد. مقدار مصرف آن به اندازه ای خواهد بود که حداقل یک اینچ مربع از سطح پوست را بپوشاند. میزان و دفعات مصرف دارو/دارونما در گروه های کنترل و مداخله یکسان خواهد بود.

Protocol summary

Study aim
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 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.
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 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.
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
The safety of local use of antimicrobial peptides, The maximum tolerable concentration of topical antimicrobial peptides

General information

Reason for update
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.
Acronym
IRCT registration information
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
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
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

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
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

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
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
Data Dictionary
Not applicable
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