Effect of Cold Atmospheric Plasma on Malassezia Folliculitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-03

Study Completion Date

2023-12-17

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.

Conditions

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Malassezia Folliculitis

Keywords

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Malassezia Malassezia folliculitis Cold atmospheric plasma Pityrosporum folliculitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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cold atmospheric plasma treatment group

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.

Group Type EXPERIMENTAL

Cold atmospheric plasma treatment device

Intervention Type DEVICE

Treat with cold atmospheric plasma treatment device.

Itraconazole capsules treatment group

Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks.

Group Type ACTIVE_COMPARATOR

Itraconazole Capsules

Intervention Type DRUG

Treat with Itraconazole capsules

Interventions

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Cold atmospheric plasma treatment device

Treat with cold atmospheric plasma treatment device.

Intervention Type DEVICE

Itraconazole Capsules

Treat with Itraconazole capsules

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yang chunjun

Head of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR