Effect of Cold Atmospheric Plasma on Malassezia Folliculitis (ECAPMF)

December 19, 2023 updated by: Yang chunjun, The Second Hospital of Anhui Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • The Second Hospital of Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Cold atmospheric plasma treatment device
Treat with cold atmospheric plasma treatment device.
Active Comparator: Itraconazole capsules treatment group
Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks.
Drug: Itraconazole Capsules
Treat with Itraconazole capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 2

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Anhui Medical University

Collaborators

Hefei CAS Ion Medical and Technical Devices Co.,Ltd

Investigators

  • Study Chair: Chunjun Yang, The Second Hospital of Anhui Medical University
  • Study Director: Na Wang, The Second Hospital of Anhui Medical University
  • Principal Investigator: Jingwen Wang, The Second Hospital of Anhui Medical University
  • Principal Investigator: Jing Gao, The Second Hospital of Anhui Medical University
  • Principal Investigator: Liyun Wang, The Second Hospital of Anhui Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Actual)

December 17, 2023

Study Completion (Actual)

December 17, 2023

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

May 9, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YX2021-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malassezia Folliculitis

Clinical Trials on Cold atmospheric plasma treatment device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe