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Completed

NCT Number: NCT04886323

Effect of Cold Atmospheric Plasma on Malassezia Folliculitis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cold atmospheric plasma treatment device

Device

Treat with cold atmospheric plasma treatment device.

Itraconazole capsules

Drug

Treat with Itraconazole capsules

Primary outcomes

  1. 50% reduction in number of lesion

    Time frame: week 2

    proportion of subjects who achieve at least a 50% reduction in total number of lesions

Secondary outcomes

  1. proportion of subjects in physician's global assessment.

    Time frame: week 2

    proportion of subjects who achieve a physician's global assessment 0 / 1.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Anhui Medical University

Other

Collaborators

  • Hefei CAS Ion Medical and Technical Devices Co.,Ltd

Registry information

Official study title

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

Acronym: ECAPMF

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 14, 2021
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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