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.
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 divided into two groups with 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
Two groups. 1. received NFM
2. received chitosan-containing mask
Main outcome variables
Reducing the incidence of skin acne
Reduce inflammation.
Improved previous acne.
General information
Reason for update
Acronym
NFM
IRCT registration information
IRCT registration number:IRCT20221113056487N1
Registration date:2023-11-26, 1402/09/05
Registration timing:prospective
Last update:2023-11-26, 1402/09/05
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 Efficacy of Cobalt Ferrite Magnetic Nanoparticles-Conjugated Chitosan-Betaine 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 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 2.5% magnetic nanoparticles, 55% chitosan solution and 40% chitosan-betaine solution and 2.5% essential oil and menthol.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
مطب متخصص پوست خانم دکتر شادفر
Full name of responsible person
مطب متخصص پوست خانم دکتر شادفر
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
Mohammad Hossein Haddadi
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