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IRCT20240207060931N1 IRCT 2024-02-25 Kerman University of Medical Sciences The effect of Nik Ara Company's cleanser in the improvement of patients with acne vulgaris CLEANIKA Anti-acne Investigating the anti-acne effect of a cleanser containing myrtle essential oil entrapped in chitosan bead from Nik Ara Company on reducing acne, levels of moisture, pH, fat, elasticity, and skin melanin in patients with acne vulgaris 2024-04-03 anticipated 60 Complete https://irct.ir/trial/75419 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process will be according to the stratified randomization method. Stratification of patients will be performed based on age, gender, and BMI, With the help of Winpepi software (V 11.6), Blinding description: The patient receives the drug or placebo in sealed envelopes that are coded. Coding is done by one of the colleagues of the project and the medicine, evaluator, and patient will be blinded. 2-3 Acne vulgaris. Intervention 1: Intervention group: Patients undergo clinical studies before starting the treatment, and the condition of their skin lesions is recorded using a high-contrast digital camera to accurately count and identify the type of lesions. Then, patients in the intervention group are prescribed a wash containing the essential oil trapped in chitosan beads. It should be noted that the intervention group will not be deprived of basic antibiotic treatment and washing agents will be prescribed as auxiliary treatment. Before starting the study and at the end of the 8th week after the start of treatment for all patients, the acne severity scoring system (GAGS) ) the global acne grading system is performed. In this system, 6 areas are examined: the forehead, right cheek, left cheek, nose, chin, and the upper part of the trunk. And the nodule has 4 points. The presence of each of these signs on the chin and nose will be worth 1 point each, the forehead and each of the cheeks will be worth 2 points, and the chest and the back of the shoulders will be worth 3 points each. Finally, the overall grade of the severity of the disease was obtained from the product of the number and score of each lesion in their location and finally the sum of the resulting numbers. A score of 1 to 18 is mild acne, 19 to 30 is moderate acne, 31 to 38 is severe acne, and more than 39 is very severe acne. Intervention 2: Control group: Patients undergo clinical studies before starting the treatment, and the condition of their skin lesions is recorded using a high-contrast digital camera to accurately count and identify the type of lesions. Then, patients in the control group will be randomly prescribed an herbal cleanser containing essential oil without chitosan seeds. It should be noted that the control group will not be deprived of basic antibiotic treatment and washing agents will be prescribed as auxiliary treatment. Before starting the study and at the end of the 8th week after starting the treatment for all patients, scoring of acne severity based on the system (GAGS) The global acne grading system is done. In this system, 6 areas are examined: forehead, right cheek, left cheek, nose, chin and the upper part of the trunk. First, each lesion is scored according to its severity: according to this system, the presence of comedone 1, papule 2, pustule. 3, and the nodule has 4 points. The presence of each of these signs on the chin and nose will be worth 1 point each, the forehead and each of the cheeks will be worth 2 points, the chest and the back of the shoulders will be worth 3 points each. Finally, the overall grade of the severity of the disease was obtained from the product of the number and score of each lesion in their location and finally the sum of the resulting numbers. A score of 1 to 18 is mild acne, 19 to 30 is moderate acne, 31 to 38 is severe acne, and more than 39 is very severe acne. Yes - There is a plan to make this available What will be shared: A part of the data such as the information related to the main outcome or the like can be shared. When: Access to study documentation after results are published To whom: It will be available for researchers working in academic and scientific institutions, and also people who are working in the industry can apply for them. Conditions: For secondary studies Where to obtain: Applicants should submit their application to the relevant person introduced through email correspondence, after the applicant's application is reviewed by the members of the group, the documents will be sent to him. Address: Kerman University of Medical Sciences, Afzalipur Faculty of Medicine, Department of Biochemistry. Name of the respondent: Mohammad Hadi Nematollahi, phone and fax: 03433257448, e-mail address: mh.nematollahi@yahoo.com How to obtain: Applicants should submit their application to the relevant person introduced through email correspondence, after the applicant's application is reviewed by the members of the group, the documents will be sent to him. It should be noted that the responsible person for this project is in contact with the patients during the follow-up period. In addition, the data and documents related to this plan will be available to patients after completion and official release. Comments:
public Mohammad Hadi Nematollahi
Department of Clinical Biochemistry, Afzalipour Medical School, Kerman University of Medical Sciences, Haft Bagh Alavi Axis, Kerman University of Medical Sciences Campus, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3325 7448 mh.nematollahi@yahoo.com Kerman University of Medical Sciences scientific Mohammad Hadi Nematollahi
Department of Clinical Biochemistry, Afzalipour Medical School, Kerman University of Medical Sciences, Haft Bagh Alavi Axis, Kerman University of Medical Sciences Campus, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3325 7448 mh.nematollahi@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with mild to moderate acne vulgaris (based on the definition of comedone, papule, and pustule lesions). Minimum age of 12 people Willing to participate in the study and complete the consent form. 10 years no limit Both People with congenital or acquired immune deficiency People with atopy and eczema and chronic skin diseases People with severe acne that is accompanied by nodules and cysts that require systemic treatments Taking anti-acne treatments in the last 4 weeks such as peeling, laser, and antibiotic drugs Pregnant women, lactating women and polycystic ovary syndrome patients People using drugs that cause acne, such as oral and topical steroids and anticonvulsants L70.0 Acne vulgaris Treatment - Drugs Placebo Intervention group: Patients undergo clinical studies before starting the treatment, and the condition of their skin lesions is recorded using a high-contrast digital camera to accurately count and identify the type of lesions. Then, patients in the intervention group are prescribed a wash containing the essential oil trapped in chitosan beads. It should be noted that the intervention group will not be deprived of basic antibiotic treatment and washing agents will be prescribed as auxiliary treatment. Before starting the study and at the end of the 8th week after the start of treatment for all patients, the acne severity scoring system (GAGS) ) the global acne grading system is performed. In this system, 6 areas are examined: the forehead, right cheek, left cheek, nose, chin, and the upper part of the trunk. And the nodule has 4 points. The presence of each of these signs on the chin and nose will be worth 1 point each, the forehead and each of the cheeks will be worth 2 points, and the chest and the back of the shoulders will be worth 3 points each. Finally, the overall grade of the severity of the disease was obtained from the product of the number and score of each lesion in their location and finally the sum of the resulting numbers. A score of 1 to 18 is mild acne, 19 to 30 is moderate acne, 31 to 38 is severe acne, and more than 39 is very severe acne. Control group: Patients undergo clinical studies before starting the treatment, and the condition of their skin lesions is recorded using a high-contrast digital camera to accurately count and identify the type of lesions. Then, patients in the control group will be randomly prescribed an herbal cleanser containing essential oil without chitosan seeds. It should be noted that the control group will not be deprived of basic antibiotic treatment and washing agents will be prescribed as auxiliary treatment. Before starting the study and at the end of the 8th week after starting the treatment for all patients, scoring of acne severity based on the system (GAGS) The global acne grading system is done. In this system, 6 areas are examined: forehead, right cheek, left cheek, nose, chin and the upper part of the trunk. First, each lesion is scored according to its severity: according to this system, the presence of comedone 1, papule 2, pustule. 3, and the nodule has 4 points. The presence of each of these signs on the chin and nose will be worth 1 point each, the forehead and each of the cheeks will be worth 2 points, the chest and the back of the shoulders will be worth 3 points each. Finally, the overall grade of the severity of the disease was obtained from the product of the number and score of each lesion in their location and finally the sum of the resulting numbers. A score of 1 to 18 is mild acne, 19 to 30 is moderate acne, 31 to 38 is severe acne, and more than 39 is very severe acne. Changes in acne grade. Timepoint: Before the intervention and 56 days after the intervention. Method of measurement: Acne grade will be calculated based on the GAGS system (Global Acne Grading System) on days 0 and 8 weeks after using the drug and placebo. Changes in skin pH. Timepoint: Before the intervention and 56 days after the intervention. Method of measurement: Skin pH values will be measured by the MST1000 device. Changes in skin moisture. Timepoint: Before the intervention and 56 days after the intervention. Method of measurement: Skin moisture levels will be measured by the MST1000 device. Changes in skin fat level. Timepoint: Before the intervention and 56 days after the intervention. Method of measurement: Skin fat level values will be measured by the MST1000 device. Changes in skin elasticity. Timepoint: Before the intervention and 56 days after the intervention. Method of measurement: Skin elasticity values will be measured by the MST1000 device. Vice-Chancellery for Research & Technology Approved 2024-02-12 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical UniversityCampus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)