An interventional study of Cold atmospheric plasma treatment device and Itraconazole Capsules in Malassezia Folliculitis, sponsored by The Second Hospital of Anhui Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by The Second Hospital of Anhui Medical University · Not applicable, Interventional, and Treatment
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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.
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.
The Second Hospital of Anhui Medical University is the lead sponsor of 30 studies on the registry; 18 are open to participants now.
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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
Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks.
Drug: Itraconazole Capsules
Treat with cold atmospheric plasma treatment device.
Treat with Itraconazole capsules
50% reduction in number of lesion
proportion of subjects who achieve at least a 50% reduction in total number of lesions
Time frame: week 2
proportion of subjects in physician's global assessment.
proportion of subjects who achieve a physician's global assessment 0 / 1.
Time frame: week 2
Plan to share: No
Ran from Aug 2022 to primary completion in Dec 2023, 16 months.
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The Second Hospital of Anhui Medical University