Condition 1: Tinea cruris. Condition 2: Tinea corporis. Dermatophytosis of groin and perianal area Dermatophytosis of body
Conditions
Interventions
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 He
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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 o | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactTahereh Shokouhi
Mazandaran University of Medical Sciences
Outcome results
None listed