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IRCT20160514027888N1 IRCT 2022-09-11 Tehran University of Medical Sciences Application of Cold Atmospheric Pressure Argon and Air Plasma to Improve the Clinical Features of the Lesions in Acne Vulgaris:Double-blind randomized clinical trial Application of Cold Atmospheric Pressure Argon and Air Plasma to Improve the Clinical Features of the Lesions in Acne Vulgaris:Double-blind randomized clinical trial 2022-09-23 anticipated 24 Complete https://irct.ir/trial/65352 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In order to determine the sample size for comparing two independent samples using G*power software and considering the significance level of 0.05 and the power of 0.8 and the effect size = 1.2 which is the large effect value and the ratio Assignment 1, the output of the software is as follows:Output:Sample size group 1 = 12Sample size group 2 = 12Total sample size = 24Actual power = 0.8020788, Randomization description: The number of 24 patients in two groups (12 patients in the cold argon plasma group, 12 patients in the ambient air plasma group) based on the random list provided by the statistical analyst (the list is provided based on random blocks). Patients will be treated based on the list provided (for example, the left side of the first patient will be treated using argon plasma): 1 Left Jet 2 Right Jet 3 Left Shower 4 Right Shower 5 Left Jet 6 Right Jet 7 Left Shower 8 Right Shower 9 Left Jet 10 Right Jet 11 Left Shower 12 Right Shower 13 Left Jet 14 Right Jet 15 Left Shower 16 Right Shower 17 Left Jet 18 Right Jet 19 Left Shower 20 Right Shower 21 Left Jet 22 Right Jet 23 Left Shower 24 Right Shower How to randomize and blind, Blinding description: Clients are selected from a random list that the operator and dermatologists cannot access. In one group, for 10 minutes, half of the person's face on one side (except the nose) is subjected to atmospheric cold plasma precipitation (shower-plasma shower-precipitation plasma), and the other is passed with the device in off mode. The patient does not know that the device is off way. In the second group, argon gas is used instead of air. Weekly visits and the duration of treatment are eight weeks. The previous design samples immediately after follow-up weeks 1, 2, 3, 4, and 8 are subjected to skin analysis and biometrics. 3 Acne vulgaris. Intervention 1: First intervention group: Argon plasma. In this method, an argon plasma device manufactured by Danesh Banyan Engineering Plasma Technology Co., Ltd. is used to process acne. In this method, the cold flame of the plasma will be shone on the acnes of one half of the face and compared with the other half of the face. This group is treated for eight weeks and one session per week. Intervention 2: Second intervention group: air plasma. In this method, air plasma device manufactured by Danesh Banyan Engineering Plasma Technology Company is used to process acne. In this method, the same as the first intervention group, the process of plasma irradiation is performed. Intervention 3: Control group: placebo. In this group, the other half of the face is processed by the probes of the device in the off state (the gas flow is open without electricity connection to form plasma in this group) and all the mentioned parameters are measured and recorded as in the plasma groups. . Yes - There is a plan to make this available What will be shared: At the end of the project, the achievements and performance of two devices on acne vulgaris will be published in a scientific article. When: The access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: To refer to achievements and referencing Where to obtain: Mohammadreza Khani +989122531497 m_khani@sbu.ac.ir How to obtain: 3 months Comments:
public Mohammadreza Khani
Shahid Beheshti University, Daneshjo Blvd., Evin, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2990 4031 m_khani@sbu.ac.ir Laser and Plasma Research Institute/ Shahid Beheshti University scientific Mohammadreza Khani
Shahid Beheshti University, Daneshjo Blvd., Evin, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2990 4031 m_khani@sbu.ac.ir Laser and Plasma Research Institute/ Shahid Beheshti University Iran (Islamic Republic of) Phototype I _ VI Fitzpatrick The number of pores ≥ 10 in each half of the face Inflammatory lesions (papules and pustules) ≥ 50 in the whole face and ≥ 10 in each half of the face Non-inflammatory lesions (open and closed comedones) ≥ 50 in the whole face and ≥ 10 in each half of the face Maximum 4 nodules with a diameter ≥ 1 cm in the whole face Atrophic scars ≥ 50 in the whole face and of any type (needle, box, rolling) ≥ 5 in each half of the face Symmetrical distribution of lesions on both sides of the face Age 16 to 55 years old Gender: Female 16 years 55 years Female Acne conglobata Acne fulminans Secondary acne (drugs and hormones) Nodulocystic acne Acne requires systemic treatment L70.0 Acne vulgaris Treatment - Devices Treatment - Devices N/A First intervention group: Argon plasma. In this method, an argon plasma device manufactured by Danesh Banyan Engineering Plasma Technology Co., Ltd. is used to process acne. In this method, the cold flame of the plasma will be shone on the acnes of one half of the face and compared with the other half of the face. This group is treated for eight weeks and one session per week. Second intervention group: air plasma. In this method, air plasma device manufactured by Danesh Banyan Engineering Plasma Technology Company is used to process acne. In this method, the same as the first intervention group, the process of plasma irradiation is performed. Control group: placebo. In this group, the other half of the face is processed by the probes of the device in the off state (the gas flow is open without electricity connection to form plasma in this group) and all the mentioned parameters are measured and recorded as in the plasma groups. . Pour and their size in each visit. Timepoint: Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment. Method of measurement: They are measured and recorded by the SKIN SCANNER device. Scars and their size. Timepoint: Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment. Method of measurement: They are measured and recorded by the SKIN SCANNER device. Inflammatory and non-inflammatory acne lesions. Timepoint: Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment. Method of measurement: They are measured and recorded by the SKIN SCANNER device. Acne severity. Timepoint: Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment. Method of measurement: They are measured and recorded by the SKIN SCANNER device. Examination of skin roughness. Timepoint: Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment. Method of measurement: They are measured and recorded by the SKIN SCANNER device. Skin biometric parameters. Timepoint: Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment. Method of measurement: This item is quantitatively measured and reported by CUTOMETER and MPA 9 devices. Shahid Beheshti University Tehran University of Medical Sciences Shahid Beheshti University Approved 2021-12-26 Faculty of Medicine - Tehran University of Medical Sciences (Research Ethics Committee) Enghebal St. - Quds St. - Porsina St. - University North Door - Building No. 1 Tehran Tehran Iran (Islamic Republic of)