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Assessing the Hydrating and Antimicrobial of Chitosan-based Facial Mack for the Treatment of Acne Vulgaris Patients

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History
# Registration date Revision Id
2 2023-12-04, 1402/09/13 287383
1 2023-11-26, 1402/09/05 286467
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  • Protocol summary

    1-To evaluate the therapeutic effect of magnetic nanoparticles conjugated to chitosan-betaine (NFM) facial mask in reducing skin acne. 2-To investigate the impact of NFM on skin fat reduction in patients with acne vulgaris. 3- To measure patient satisfaction in using NFM with magnet. 4- To assess the efficacy of NFM in reducing skin acne.
    1-To evaluate the therapeutic effect of Chitosan-Facial Mask (CFM) facial mask in reducing skin acne. 2-To investigate the impact of CFM on skin fat reduction in patients with acne vulgaris. 3- To measure patient satisfaction in using CFM . 4- To assess the efficacy of NFM in reducing skin acne.
    1- تعیین اثر درمانی ماسک صورت نانوذرات مغناطیسی کونژوگه به کیتوزان-بتائین (NFM) بر کاهش آکنه های پوستی 2- تعیین اثر کاهش چربی پوست با استفاده از NFM در بیماران آکنه ولگاریس 3- تعیین میزان رضایت بیمار در استفاده از NFM به همراه آهنربا 4- تعیین میزان اثربخشی استفاده از NFM در کاهش آکنه های پوستی
    1- تعیین اثر درمانی ماسک صورت حاوی کیتوزان (CFM) بر کاهش آکنه های پوستی 2- تعیین اثر کاهش چربی پوست با استفاده از CFM در بیماران آکنه ولگاریس 3- تعیین میزان رضایت بیمار در استفاده از CFM 4- تعیین میزان اثربخشی استفاده از CFM در کاهش آکنه های پوستی
    The study will involve a sample of participants with moderate acne. Each participant will have their face divided into two halves: the left side and the right side. One side will be treated with a face mask, while the other side will follow a routine treatment. All participants divided into two groups with 15 members. Treated half of face is persist during study. The study is parallel.
    The study will involve a sample of participants with moderate acne. Each participant will have their face divided into two halves: the left side and the right side. One side will be treated with a face mask, while the other side will follow a routine treatment. All participants (15 members). Treated half of face is persist during study. The study is parallel.
    این مطالعه شامل نمونه ای از شرکت کنندگان با آکنه ولگاریس مودریت است. شرکت کنندگان به صورت غیر تصادفی با درجه بندی بیماری در دو گروه تقسیم می شوند. در هر گروه 15 نفر. هر شرکت کننده صورت خود را به دو نیمه تقسیم می کند: سمت چپ و سمت راست. یک طرف با ماسک صورت درمان می شود، در حالی که طرف دیگر ماسک دریافت نمی کند. بیمار تمام درمان تجویز شده را برای کل صورت انجام میدهد. نیمه که ماسک دریافت میکند تا پایان 6 هفته ثابت می ماند. مطالعه به صورت موازی است.
    این مطالعه شامل نمونه ای از شرکت کنندگان با آکنه ولگاریس مودریت است. شرکت کنندگان به صورت غیر تصادفی با درجه بندی بیماری در یک گروه تقسیم می شوند. یک گروه 15 نفره. هر شرکت کننده صورت خود را به دو نیمه تقسیم می کند: سمت چپ و سمت راست. یک طرف با ماسک صورت درمان می شود، در حالی که طرف دیگر ماسک دریافت نمی کند. بیمار تمام درمان تجویز شده را برای کل صورت انجام میدهد. نیمه که ماسک دریافت میکند تا پایان 6 هفته ثابت می ماند. مطالعه به صورت موازی است.
    Two groups. 1. received NFM 2. received chitosan-containing mask
    received CFM
    گروه یک گیرنده ماسک با نانوذرات کونژوگه گروه دوم گیرنده ماسک حاوی محلول کیتوزان
    گیرنده ماسک حاوی محلول کیتوزان

  • General information

    NFM
    CFM
    empty
    The inconsistency between the title of the proposed study and the title of the proposal approved by the university's ethics committee poses a cause for concern.
    empty
    مغایرت عنوان و محتوای درج شده با عنوان و محتوای پروپزال تایید شده توسط کمیته اخلاق دانشگاه
    Assessing the Efficacy of Cobalt Ferrite Magnetic Nanoparticles-Conjugated Chitosan-Betaine for the Treatment of Acne Vulgaris Patients
    Assessing the Hydrating and Antimicrobial of Chitosan-based Facial Mack for the Treatment of Acne Vulgaris Patients
    بررسی اثر درمانی پوشینه صورت نانوذرات مغناطیسی کونژوگه به کیتوزان-بتائین در بیماران مبتلا به آکنه ولگاریس
    بررسی اثر درمانی پوشینه مرطوب کننده و ضد میکروبی مراقبت از پوست بر پایه کیتوزان
    This study aims to examine the effectiveness of face masks in improving acne by conducting a half-face study design. In this design, one half of the face receives treatment with a face mask, while the other half undergoes routine treatment. By comparing the two areas, we can evaluate the specific impact of the face mask on acne improvement. The study will involve a sample of participants with moderate acne. Each participant will have their face divided into two halves: the left side and the right side. One side will be treated with a face mask, while the other side will follow a routine treatment. All participants divided into two groups with 15 members. The participants will be instructed to apply the face mask to the designated half of their face according to the provided guidelines. Treated half of face is persist during study. The study will run for a period of six weeks, during which the participants will be monitored closely. Regular evaluations will be conducted to assess the progress of acne improvement on both sides of the face. The evaluations will include visual examination, as well as the use of standardized acne severity scales to quantify the changes. The participants will also be asked to report any subjective improvements, such as reduced redness, inflammation, and overall skin texture.
    This study aims to examine the effectiveness of Chitosan 0.5% face masks in improving acne by conducting a half-face study design. In this design, one half of the face receives treatment with a face mask, while the other half undergoes routine treatment. By comparing the two areas, we can evaluate the specific impact of the face mask on acne improvement. The study will involve a sample of participants with moderate acne. Each participant will have their face divided into two halves: the left side and the right side. One side will be treated with a face mask, while the other side will follow a routine treatment. All participants divided into two groups with 15 members. The participants will be instructed to apply the face mask to the designated half of their face according to the provided guidelines. Treated half of face is persist during study. The study will run for a period of six weeks, during which the participants will be monitored closely. Regular evaluations will be conducted to assess the progress of acne improvement on both sides of the face. The evaluations will include visual examination, as well as the use of standardized acne severity scales to quantify the changes. The participants will also be asked to report any subjective improvements, such as reduced redness, inflammation, and overall skin texture.
    این مطالعه با هدف بررسی اثربخشی ماسک های صورت نانوذرات مغناطیسی کونژوگه به کیتوزان-بتائین در بهبود اکنه با طرح مطالعه نیمه-صورت انجام می شود. در این طراحی، نیمی از صورت با ماسک صورت درمان می شود، در حالی که نیمی دیگر تحت درمان معمول قرار می گیرد. با مقایسه این دو منطقه، می توانیم تاثیر خاص ماسک صورت را بر بهبود اکنه ارزیابی کرد. این مطالعه شامل نمونه ای از شرکت کنندگان با آکنه ولگاریس مودریت است. شرکت کنندگان به صورت غیر انتخابی با درجه بندی بیماری در دو گروه تقسیم می شوند. در هر گروه 15 نفر. هر شرکت کننده صورت خود را به دو نیمه تقسیم می کند: سمت چپ و سمت راست. یک طرف با ماسک صورت درمان می شود، در حالی که طرف دیگر ماسک دریافت نمی کند. بیمار تمام درمان تجویز شده را برای کل صورت انجام میدهد. به شرکت کنندگان اطلاع داده می شود که ماسک صورت را بر روی نیمی از صورت تعیین شده خود با توجه به دستورالعمل های ارائه شده اعمال کنند. نیمه که ماسک دریافت میکند تا پایان 6 هفته ثابت می ماند.این مطالعه به مدت شش هفته اجرا خواهد شد که در طی آن شرکت کنندگان از نزدیک تحت نظارت قرار خواهند گرفت. ارزیابی های منظم برای ارزیابی پیشرفت بهبود اکنه در هر دو طرف صورت انجام می شود. ارزیابی ها شامل معاینه بصری و همچنین استفاده از مقیاس های استاندارد شدت آکنه برای اندازه گیری تغییرات است. همچنین از شرکت کنندگان خواسته می شود هر گونه پیشرفت ذهنی مانند کاهش قرمزی، التهاب و بافت کلی پوست را گزارش دهند.
    این مطالعه با هدف بررسی اثربخشی پوشینه صورت حاوی محلول کیتوزان 0.5% در بهبود اکنه با طرح مطالعه نیمه-صورت انجام می شود. در این طراحی، نیمی از صورت با ماسک صورت درمان می شود، در حالی که نیمی دیگر تحت درمان معمول قرار می گیرد. با مقایسه این دو منطقه، می توانیم تاثیر خاص ماسک صورت را بر بهبود اکنه ارزیابی کرد. این مطالعه شامل نمونه ای از شرکت کنندگان با آکنه ولگاریس مودریت است. شرکت کنندگان به صورت غیر انتخابی با درجه بندی بیماری در دو گروه تقسیم می شوند. در هر گروه 15 نفر. هر شرکت کننده صورت خود را به دو نیمه تقسیم می کند: سمت چپ و سمت راست. یک طرف با ماسک صورت درمان می شود، در حالی که طرف دیگر ماسک دریافت نمی کند. بیمار تمام درمان تجویز شده را برای کل صورت انجام میدهد. به شرکت کنندگان اطلاع داده می شود که ماسک صورت را بر روی نیمی از صورت تعیین شده خود با توجه به دستورالعمل های ارائه شده اعمال کنند. نیمه که ماسک دریافت میکند تا پایان 6 هفته ثابت می ماند.این مطالعه به مدت شش هفته اجرا خواهد شد که در طی آن شرکت کنندگان از نزدیک تحت نظارت قرار خواهند گرفت. ارزیابی های منظم برای ارزیابی پیشرفت بهبود اکنه در هر دو طرف صورت انجام می شود. ارزیابی ها شامل معاینه بصری و همچنین استفاده از مقیاس های استاندارد شدت آکنه برای اندازه گیری تغییرات است. همچنین از شرکت کنندگان خواسته می شود هر گونه پیشرفت ذهنی مانند کاهش قرمزی، التهاب و بافت کلی پوست را گزارش دهند.

  • Intervention groups

    #1
    Intervention group: Recipient of the mask of magnetic nanoparticles conjugated to chitosan-betaine. The mask contains 2.5% magnetic nanoparticles, 55% chitosan solution and 40% chitosan-betaine solution and 2.5% essential oil and menthol.
    Intervention group: Recipient of the mask of magnetic nanoparticles conjugated to chitosan-betaine. The mask contains 97.5% Chitosan solution (0.5%) and 2.5% essential oil and menthol.
    گروه مداخله: دریافت کننده ماسک نانوذرات مغناطیسی کونژوگه به کیتوزان-بتائین. این گروه ماسک حاوی 2.5 درصد نانوذرات مغناطیسی، 55 درصد محلول کیتوزان و 40 درصد محلول کیتوزان-بتائین و 2.5 درصد اسانس و منتول است.
    گروه مداخله: دریافت کننده پوشینه حاوی محلول کیتوزان 0.5 درصد است. این گروه ماسک حاوی 97.5 درصد محلول کیتوزان و 2.5 درصد اسانس و منتول است.
    #2
    Treatment - Other
    empty
    Intervention group: Intervention group: Recipient of the mask of chitosan. The mask contains 55% chitosan solution and 40% DDW and 2.5% essential oil and menthol.
    empty
    گروه مداخله: دریافت کننده ماسک محلول کیتوزان. این گروه ماسک 55 درصد محلول کیتوزان و 42.5 درصد DDW و 2.5 درصد اسانس و منتول است.
    empty

  • Recruitment centers

    #1
    Name of recruitment center - English: مطب متخصص پوست خانم دکتر شادفر
    Name of recruitment center - Persian: Dr. Shadfar's dermatologist
    Full name of responsible person - English: مطب متخصص پوست خانم دکتر شادفر
    Full name of responsible person - Persian: Dr. Shadfar's dermatologist
    Street address - English: South Saadi St.
    Street address - Persian: خیابان سعدی جنوبی.
    City - English: Ilam
    City - Persian: ایلام
    Province: Ilam
    Country: Iran (Islamic Republic of)
    Postal code: 6931659687
    Phone: +98 21 8670 5503
    Fax:
    Email: faribashadfar03@gmail.com
    Web page address:
    Name of recruitment center - English: Dr. Shadfar's dermatologist
    Name of recruitment center - Persian: مطب متخصص پوست خانم دکتر شادفر
    Full name of responsible person - English: Fariba Shadfar
    Full name of responsible person - Persian: فریبا شادفر
    Street address - English: South Saadi St.
    Street address - Persian: خیابان سعدی جنوبی.
    City - English: Ilam
    City - Persian: ایلام
    Province: Ilam
    Country: Iran (Islamic Republic of)
    Postal code: 6931659687
    Phone: +98 21 8670 5503
    Fax:
    Email: faribashadfar03@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Hossein Haddadi
    Full name of responsible person - Persian: محمد حسین حدادی
    Street address - English: Banganjab ave., pajohesh Blvd, Ilam university of medical science
    Street address - Persian: خیابان بانگنجاب، بلوار پژوهش، دانشگاه علوم پزشکی ایلام
    City - English: Ilam
    City - Persian: ایلام
    Province: Ilam
    Country: Iran (Islamic Republic of)
    Postal code: 6931678588
    Phone: +98 21 8670 5503
    Fax:
    Email: haddadi841@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Abas Maleki
    Full name of responsible person - Persian: عباس ملکی
    Street address - English: Banganjab ave., pajohesh Blvd, Ilam university of medical science
    Street address - Persian: خیابان بانگنجاب، بلوار پژوهش، دانشگاه علوم پزشکی ایلام
    City - English: Ilam
    City - Persian: ایلام
    Province: Ilam
    Country: Iran (Islamic Republic of)
    Postal code: 6931678588
    Phone: +98 21 8670 5503
    Fax:
    Email: haddadi841@gmail.com
    Web page address:

Protocol summary

Study aim
1-To evaluate the therapeutic effect of Chitosan-Facial Mask (CFM) facial mask in reducing skin acne. 2-To investigate the impact of CFM on skin fat reduction in patients with acne vulgaris. 3- To measure patient satisfaction in using CFM . 4- To assess the efficacy of NFM in reducing skin acne.
Design
The study will involve a sample of participants with moderate acne. Each participant will have their face divided into two halves: the left side and the right side. One side will be treated with a face mask, while the other side will follow a routine treatment. All participants (15 members). Treated half of face is persist during study. The study is parallel.
Settings and conduct
Patients with acne vulgaris referred to the dermatologist's office. After obtaining consent, they are enrolled in the study.
Participants/Inclusion and exclusion criteria
Acne vulgaris patients Inclusion Criteria; 1. Diagnosis of Acne Vulgaris. 2. Severity of Acne. Using standardized grading systems such as the Global Acne Grading System (GAGS) or the Investigator's Global Assessment (IGA). 3. No Internal Interventions. 4. Age Range: 12-65 5. Gender: - The study is open to both males and females. Exclusion criteria; 1. Patients with a history of other dermatological conditions (rosacea or dermatitis) or systemic diseases. 2.Pregnancy and Breastfeeding. 3.Medications: systemic corticosteroids or hormonal therapies. 4. Severe Acne.
Intervention groups
received CFM
Main outcome variables
Reducing the incidence of skin acne Reduce inflammation. Improved previous acne.

General information

Reason for update
The inconsistency between the title of the proposed study and the title of the proposal approved by the university's ethics committee poses a cause for concern.
Acronym
CFM
IRCT registration information
IRCT registration number: IRCT20221113056487N1
Registration date: 2023-11-26, 1402/09/05
Registration timing: prospective

Last update: 2023-12-05, 1402/09/14
Update count: 1
Registration date
2023-11-26, 1402/09/05
Registrant information
Name
Mohammad Hossein Haddadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3334 6098
Email address
haddadi841@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-12, 1402/09/21
Expected recruitment end date
2024-02-10, 1402/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Hydrating and Antimicrobial of Chitosan-based Facial Mack for the Treatment of Acne Vulgaris Patients
Public title
Assessing the Efficacy of Chitosan-Based Facial Masks in Acne Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate-Acne Vulgaris Patients
Exclusion criteria:
Pregnancy and Breastfeeding Autoimmune diseases and systemic diseases Rosacea or Dermatitis Severe acne vulgaris
Age
From 12 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
The participants will be instructed to apply the face mask to the designated half of their face according to the provided guidelines. Treated half of face is persist during study. The study will run for a period of six weeks, during which the participants will be monitored closely.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study aims to examine the effectiveness of Chitosan 0.5% face masks in improving acne by conducting a half-face study design. In this design, one half of the face receives treatment with a face mask, while the other half undergoes routine treatment. By comparing the two areas, we can evaluate the specific impact of the face mask on acne improvement. The study will involve a sample of participants with moderate acne. Each participant will have their face divided into two halves: the left side and the right side. One side will be treated with a face mask, while the other side will follow a routine treatment. All participants divided into two groups with 15 members. The participants will be instructed to apply the face mask to the designated half of their face according to the provided guidelines. Treated half of face is persist during study. The study will run for a period of six weeks, during which the participants will be monitored closely. Regular evaluations will be conducted to assess the progress of acne improvement on both sides of the face. The evaluations will include visual examination, as well as the use of standardized acne severity scales to quantify the changes. The participants will also be asked to report any subjective improvements, such as reduced redness, inflammation, and overall skin texture.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Ilam University of Medical Sciences
Street address
Banganjab Ave. Pjohesh Blvd, Ilam university of medical science
City
Ilam
Province
Ilam
Postal code
6931678587
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.MEDILAM.REC.1401.198

Health conditions studied

1

Description of health condition studied
Moderate-Acne Vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris

Primary outcomes

1

Description
Reduce skin fat.
Timepoint
6 Weeks
Method of measurement
Abnormal shine of the skin, photography, presence of acne

2

Description
Average number of acne lesions
Timepoint
The average number of acnes is measured on the first day and then every two weeks.
Method of measurement
Observational.

3

Description
Average number of comedones
Timepoint
The average number of comedones is measured on the first day and then every two weeks.
Method of measurement
Observational.

4

Description
Average number of inflamed papules.
Timepoint
The average number of inflamed papules is measured on the first day and then every two weeks.
Method of measurement
Observational.

5

Description
The rate of recovery of lesions.
Timepoint
Every two weeks.
Method of measurement
Observational.

Secondary outcomes

1

Description
Satisfaction score of mask use.
Timepoint
The end of study.
Method of measurement
Questionnaire form of lay et al.

2

Description
Satisfaction score of skin fat mask.
Timepoint
The end of study.
Method of measurement
Questionnaire.

Intervention groups

1

Description
Intervention group: Recipient of the mask of magnetic nanoparticles conjugated to chitosan-betaine. The mask contains 97.5% Chitosan solution (0.5%) and 2.5% essential oil and menthol.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Shadfar's dermatologist
Full name of responsible person
Fariba Shadfar
Street address
South Saadi St.
City
Ilam
Province
Ilam
Postal code
6931659687
Phone
+98 21 8670 5503
Email
faribashadfar03@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Abas Maleki
Street address
Banganjab ave., pajohesh Blvd, Ilam university of medical science
City
Ilam
Province
Ilam
Postal code
6931678588
Phone
+98 21 8670 5503
Email
haddadi841@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellor for Research and Technology Affairs, Ilam University of Medical Science.
Proportion provided by this source
100
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
Ilam University of Medical Sciences
Full name of responsible person
Mohammd Hossein Haddadi
Position
Associate professor of medical biotechnology
Latest degree
Ph.D.
Other areas of specialty/work
Biotechnology
Street address
Banganjab Ave., Pajohesh Blvd., Ilam university of medical science
City
Ilam
Province
Ilam
Postal code
6931678588
Phone
+98 21 8670 5503
Email
haddadi841@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mohammad Hossein Haddadi
Position
Associate professor of medical biotechnology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Banganjab Ave., Pajohesh Blvd., Ilam university of medical science
City
Ilam
Province
Ilam
Postal code
6931687588
Phone
+98 21 8670 5503
Email
haddadi841@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mohammad Hossein Haddadi
Position
Associate professor of medical biotechnology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Banganjab Ave., Pajohesh Blvd., Ilam university of medical science
City
Ilam
Province
Ilam
Postal code
6931687588
Phone
+98 21 8670 5503
Email
haddadi841@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Photos taken in the first days and every two weeks.
When the data will become available and for how long
2026
To whom data/document is available
Vice-Chancellor for Research and Technology Affairs
Under which criteria data/document could be used
To clarify and use data to create artificial intelligence software
From where data/document is obtainable
Vice-Chancellor for Research and Technology Affairs
What processes are involved for a request to access data/document
Written request to the Vice President of Research and Technology, Ilam University of Medical Sciences
Comments
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