Effect of Cold Atmospheric Plasma on Malassezia Folliculitis

Not Applicable

Completed

• Conditions: Malassezia Folliculitis
• Interventions: Device: Cold atmospheric plasma treatment device; Drug: Itraconazole Capsules

• Registration Number: NCT04886323
• Lead Sponsor: The Second Hospital of Anhui Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-05-09
• Study First Posted: 2021-05-14
• Study Start: 2022-08-03
• Status Verified: 2023-12
• Primary Completion: 2023-12-17
• Study Completion: 2023-12-17
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cold atmospheric plasma treatment group	Cold atmospheric plasma treatment device	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.
Itraconazole capsules treatment group	Itraconazole Capsules	Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks.

Primary Outcome Measures

Name	Time	Method
50% reduction in number of lesion	week 2	proportion of subjects who achieve at least a 50% reduction in total number of lesions

Secondary Outcome Measures

Name	Time	Method
proportion of subjects in physician's global assessment.	week 2	proportion of subjects who achieve a physician's global assessment 0 / 1.

Trial Locations

Locations (1)

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China