Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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Patients with acne vulgaris referred to the dermatologist's office. After obtaining consent, they are enrolled in the study.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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received CFM
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Main outcome variables
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Reducing the incidence of skin acne
Reduce inflammation.
Improved previous acne.
General information
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Reason for update
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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.
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Acronym
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CFM
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IRCT registration information
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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
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Registration date
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2023-11-26, 1402/09/05
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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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2023-12-12, 1402/09/21
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Expected recruitment end date
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2024-02-10, 1402/11/21
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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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Assessing the Hydrating and Antimicrobial of Chitosan-based Facial Mack for the Treatment of Acne Vulgaris Patients
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Public title
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Assessing the Efficacy of Chitosan-Based Facial Masks in Acne Treatment
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Moderate-Acne Vulgaris Patients
Exclusion criteria:
Pregnancy and Breastfeeding
Autoimmune diseases and systemic diseases
Rosacea or Dermatitis
Severe acne vulgaris
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Age
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From 12 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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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.
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2023-01-09, 1401/10/19
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Ethics committee reference number
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IR.MEDILAM.REC.1401.198
Health conditions studied
1
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Description of health condition studied
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Moderate-Acne Vulgaris
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ICD-10 code
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L70.0
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ICD-10 code description
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Acne vulgaris
Primary outcomes
1
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Description
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Reduce skin fat.
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Timepoint
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6 Weeks
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Method of measurement
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Abnormal shine of the skin, photography, presence of acne
2
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Description
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Average number of acne lesions
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Timepoint
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The average number of acnes is measured on the first day and then every two weeks.
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Method of measurement
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Observational.
3
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Description
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Average number of comedones
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Timepoint
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The average number of comedones is measured on the first day and then every two weeks.
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Method of measurement
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Observational.
4
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Description
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Average number of inflamed papules.
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Timepoint
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The average number of inflamed papules is measured on the first day and then every two weeks.
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Method of measurement
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Observational.
5
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Description
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The rate of recovery of lesions.
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Timepoint
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Every two weeks.
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Method of measurement
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Observational.
Secondary outcomes
1
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Description
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Satisfaction score of mask use.
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Timepoint
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The end of study.
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Method of measurement
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Questionnaire form of lay et al.
2
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Description
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Satisfaction score of skin fat mask.
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Timepoint
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The end of study.
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Method of measurement
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Questionnaire.
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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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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Vice-Chancellor for Research and Technology Affairs, Ilam University of Medical Science.
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Proportion provided by this source
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100
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Photos taken in the first days and every two weeks.
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When the data will become available and for how long
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2026
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To whom data/document is available
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Vice-Chancellor for Research and Technology Affairs
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Under which criteria data/document could be used
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To clarify and use data to create artificial intelligence software
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From where data/document is obtainable
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Vice-Chancellor for Research and Technology Affairs
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What processes are involved for a request to access data/document
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Written request to the Vice President of Research and Technology, Ilam University of Medical Sciences
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Comments
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