Malassezia Folliculitis
Conditions
Keywords
Malassezia, Malassezia folliculitis, Cold atmospheric plasma, Pityrosporum folliculitis
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.
Interventions
DEVICECold atmospheric plasma treatment device
Treat with cold atmospheric plasma treatment device.
Treat with Itraconazole capsules
Sponsors
Hefei CAS Ion Medical and Technical Devices Co.,Ltd
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 50% reduction in number of lesion | week 2 | proportion of subjects who achieve at least a 50% reduction in total number of lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of subjects in physician's global assessment. | week 2 | proportion of subjects who achieve a physician's global assessment 0 / 1. |
Countries
China
Outcome results
None listed