Effect of Cold Atmospheric Plasma on Malassezia Folliculitis

Study Overview
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Brief Summary
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The cold atmospheric plasma may provide a new and effective method for the treatment of Malassezia folliculitis. The investigators conduct this randomized controlled trial to evaluate the effectiveness and safety of cold atmospheric plasma on Malassezia folliculitis. Participants entered this double-blind placebo-controlled trial will randomly assign to treatment with either cold atmospheric plasma or antifungal drugs. The differences of treatment effects of the two groups will be observed and compared.

Detailed Description
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Malassezia folliculitis is a common disease of young and middle-aged people. It is an inflammatory disease caused by Malassezia infection. Generally, Topical or systemic use of antifungal drugs are the first choice for treatment but sometimes are limited due to adverse drug reactions and drug resistance. Cold atmospheric plasma has an inhibitory or killing effect on pathogenic microorganisms including fungi and has no obvious adverse damage to normal tissues. The investigators conduct this randomized controlled trial to study the effect of cold atmospheric plasma on Malassezia folliculitis, and evaluate its effectiveness and safety for Malassezia folliculitis. All data are recorded and compared after the end of the experiment.

Official Title
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Effect of Cold Atmospheric Plasma on Malassezia Folliculitis: a Randomized Controlled Trial

Conditions
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Malassezia Folliculitis

Intervention / Treatment
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* Device: Cold atmospheric plasma treatment device
* Drug: Itraconazole Capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are clinical presentation of Malassezia folliculitis in seborrheic areas. The diagnoses are mycologically verified by experienced laboratory technicians. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent. Exclusion Criteria: Combined with other serious systemic diseases. History of topical corticosteroids within 2 weeks or history of systemic corticosteroids within 1 month. History of immunosuppressive drugs within 1 month. History of topical antifungal medication within 2 weeks or systemic antifungal medication within 3 months. Pregnant and lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cold atmospheric plasma treatment group<br>Patients are treated with a plasma device. Each treatment time was 3min per area based on the lesion size.The frequency of treatment is once a day. The duration of the treatment period is 2weeks. | Device: Cold atmospheric plasma treatment device<br>* Treat with cold atmospheric plasma treatment device.<br>|
| Active Comparator: Itraconazole capsules treatment group<br>Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks. | Drug: Itraconazole Capsules<br>* Treat with Itraconazole capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% reduction in number of lesion | proportion of subjects who achieve at least a 50% reduction in total number of lesions | week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects in physician's global assessment. | proportion of subjects who achieve a physician's global assessment 0 / 1. | week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malassezia, Malassezia folliculitis, Cold atmospheric plasma, Pityrosporum folliculitis