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IRCT20250712066462N1 IRCT 2025-09-11 Mazandaran University of Medical Sciences Investigation of the effects of Cold Atmospheric Plasma in the treatment of patients with dermatophytosis CAP Investigation of the effects of Cold Atmospheric Plasma in the treatment of patients with refractory dermatophytosis: A triple-blinded randomized clinical trial 2025-08-23 anticipated 52 Complete https://irct.ir/trial/84772 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order for our study to be completely scientific and unbiased, we use the block randomization method. That is, patients are randomly divided into two groups after the doctor and laboratory approval and signing a written consent form. This ensures that the distribution of people in the intervention and control groups is fair and the results of the study are not affected by side factors. How are patients placed in groups? The block randomization method is used, which means that patients are placed in blocks of four and then assigned to one of two groups. The intervention group (CPT) includes patients who receive cold atmospheric plasma (CAP) along with itraconazole. The control group (SWT) will receive itraconazole alone. This allocation is done randomly and the patients' information is recorded in the Master Sheet, Blinding description: When entering the study, patients receive a specific number that is placed in an opaque envelope, so that even the doctor will not know the type of grouping until the moment the treatment starts. Why is blinding important? To ensure that the results are more accurate and unbiased, the study is designed as a triple-blind. This means that neither the patient, nor the evaluator, nor the laboratory specialist know the type of treatment. The treating doctor assigns the patients to the groups using random codes (via the randomizer.org website). How are the conditions of the groups kept equal? All patients receive the drug itraconazole, but the main difference is that in the intervention group, cold atmospheric plasma (CAP) is also added to the treatment. In order to ensure that the conditions of the two groups are similar, an inactive CAP device (placebo) is also used in the control group, meaning that the patient will not notice any difference in the treatment method. This method helps to accurately assess the true effect of cold plasma and ensure that any changes in patients' condition are due to CAP and not other factors. 3 Condition 1: Tinea cruris. Condition 2: Tinea corporis. Intervention 1: Intervention group: In addition to receiving standard topical antifungal treatment, patients in this group will be treated with Cold Atmospheric Plasma. Cold plasma is produced by a Helium-based Atmospheric Pressure Plasma Jet device manufactured by [insert company name], using pure helium gas, and is irradiated directly onto the surface of the fungal lesion. Plasma application parameters include: Operating frequency: 13 kHz Output voltage: 6 kV Nozzle-to-skin distance: 10 mm Duration of each session: 3 minutes for each lesion Number of treatment sessions: 3 times a week for 4 consecutive weeks (12 sessions in total) All irradiation sessions are performed by a trained operator and under the supervision of a dermatologist. In addition to this treatment, patients will apply the topical antifungal drug clotrimazole 1% (manufactured by [company name]) to the lesion twice daily according to standard instructions. Patients will be evaluated for clinical and mycological improvement before starting treatment and at the end of the fourth week. Intervention 2: Control group: Patients in this group will only receive standard topical antifungal treatment and will not receive any atmospheric cold plasma irradiation. Standard treatment includes the use of Clotrimazole 1% topical ointment manufactured by [insert company name] Pharmaceutical Company. How to use the drug: Apply a sufficient amount of the drug to the skin lesion. The drug is used twice a day (morning and evening). Duration of use: For 4 consecutive weeks. All patients will be continuously followed up to ensure that they follow the drug instructions correctly and do not use additional treatments during the study. At the end of the fourth week, clinical and laboratory evaluations will be performed to assess improvement. Yes - There is a plan to make this available What will be shared: All patient information listed in the questionnaire will be shared. When: Will be available upon request. To whom: This data will only be available to researchers working in academic and scientific institutions. Conditions: Information that has not been analyzed by us will be available for use with intellectual property rights preserved. Where to obtain: shokohi.tahereh@gmail.com How to obtain: After sending the message by the applicant, the information will be sent via email within two weeks. Comments:
public Tahereh Shokouhi
Department of Mycology, School of Medicine, Mazandaran University of Medical Sciences, 18 Km Farahabad Rd
Sari Iran (Islamic Republic of) 48471-91971 00981133543080_1 ext. 2403 tahereh.shokohi@gmail.com Mazandaran University of Medical Sciences scientific Tahereh Shokohi
Department of Mycology, School of Medicine, Mazandaran University of Medical Sciences, 18 Km Farahabad Rd
Sari Iran (Islamic Republic of) 48471-91971 +98 11 3543 0801 ext. 2403 shokohi.tahereh@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with resistant dermatophytosis Patients over 12 years of age (both sexes) Suffering from mild to moderate dermatophytosis (body and groin alopecia) Failure to respond to standard treatments within 4 to 6 weeks 12 years no limit Both Patients with dermatophytosis who respond to conventional antifungal treatments. Including pregnant and lactating women and children under 12 years of age. Patients with extensive involvement of more than 10% of the body Patients with uncontrolled diabetes Immunosuppressed individuals Patients taking steroids in the last 4 weeks B35.6 B35.4 Dermatophytosis of groin and perianal area Dermatophytosis of body Treatment - Drugs Treatment - Drugs Intervention group: In addition to receiving standard topical antifungal treatment, patients in this group will be treated with Cold Atmospheric Plasma. Cold plasma is produced by a Helium-based Atmospheric Pressure Plasma Jet device manufactured by [insert company name], using pure helium gas, and is irradiated directly onto the surface of the fungal lesion. Plasma application parameters include: Operating frequency: 13 kHz Output voltage: 6 kV Nozzle-to-skin distance: 10 mm Duration of each session: 3 minutes for each lesion Number of treatment sessions: 3 times a week for 4 consecutive weeks (12 sessions in total) All irradiation sessions are performed by a trained operator and under the supervision of a dermatologist. In addition to this treatment, patients will apply the topical antifungal drug clotrimazole 1% (manufactured by [company name]) to the lesion twice daily according to standard instructions. Patients will be evaluated for clinical and mycological improvement before starting treatment and at the end of the fourth week. Control group: Patients in this group will only receive standard topical antifungal treatment and will not receive any atmospheric cold plasma irradiation. Standard treatment includes the use of Clotrimazole 1% topical ointment manufactured by [insert company name] Pharmaceutical Company. How to use the drug: Apply a sufficient amount of the drug to the skin lesion. The drug is used twice a day (morning and evening). Duration of use: For 4 consecutive weeks. All patients will be continuously followed up to ensure that they follow the drug instructions correctly and do not use additional treatments during the study. At the end of the fourth week, clinical and laboratory evaluations will be performed to assess improvement. Mycological Cure: This variable is designed to measure the effectiveness of the intervention in eliminating the fungal agent of the disease. Laboratory cure is achieved when both mycological criteria, namely direct microscopic observation with potassium hydroxide (KOH) and the result of fungal culture on dextrose agar containing chloramphenicol and cyclohexamide, are negative. The negativity of both tests indicates complete elimination of dermatophytes from the lesion site and is considered as successful laboratory treatment. This is a qualitative variable and the results are reported as "positive" or "negative". This outcome is considered one of the main outcomes of the study and the sample size was also determined based on it. Timepoint: Measurements of microscopic and fungal culture results will be performed at the beginning of the study (before treatment begins) and four weeks after the end of treatment. Method of measurement: To measure this variable, a sample of the affected area is taken and examined in a medical mycology laboratory. First, microscopic examination is performed using a potassium hydroxide (KOH) solution, and then fungal culture is performed in SDA medium containing chloramphenicol and cyclohexamide. Interpretation of the results is performed by a person blinded to the intervention grouping, and the results are reported qualitatively (positive or negative). Clinical Cure based on clinical scoring,This primary outcome variable is designed to clinically assess the effectiveness of the intervention. Clinical improvement is measured by a Visual Analogue Scale (VAS) including a scale of 0 to 10 for the severity of itching, burning, and scaling, as well as the Dermatophytosis Severity and Involvement Index (DeASI). These assessments are performed by a dermatologist (blinded to the type of intervention) at two time points. A significant reduction in scores from baseline is considered clinical improvement. This variable is quantitative and plays an important role in the analysis of treatment effectiveness. Timepoint: Assessment of the severity of skin lesions and clinical symptoms will be performed at the beginning of the study (before the start of treatment) and four weeks after the start of the therapeutic intervention. Method of measurement: This variable is measured using a numerical scale from zero to ten (Visual Analogue Scale) for symptoms of itching, inflammation and scaling and the DeASI index for a composite assessment of the severity and extent of skin lesions. These measurements are performed by a dermatologist who is unaware of the type of intervention and are recorded on standard forms. The change in scores from baseline will be analyzed and recorded. Relapse Rate: This variable is designed to assess the stability of the treatment effect and the likelihood of symptoms returning after the end of treatment. Relapse is defined as the patient experiencing a recurrence of clinical symptoms (e.g., itching, inflammation, skin lesions) during follow-up after achieving complete clinical and microbiological recovery, along with positive results in mycological examination (direct observation and/or positive culture). The measurement of this variable indicates the ability of the intervention to prevent relapse and is recorded qualitatively (relapsed/not relapsed). Timepoint: Six weeks after the end of treatment. Method of measurement: At the follow-up visit 6 weeks after treatment, the patient is examined for recurrence of clinical symptoms (by a physician blinded to the intervention) and a sample is taken from the area of the suspected lesion. The sample is subjected to microscopic examination with potassium hydroxide solution and fungal culture. If both clinical and laboratory examinations are positive again, the disease recurrence is confirmed and recorded. Deputy of research and technologyMazandaran University of Medical Sciences Approved 2025-07-16 Ethics Committee of Mazandaran University of Medical Sciences Moalem Sq. Research deputy of Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)