Clinical trial NCT04886323: Effect of Cold Atmospheric Plasma on Malassezia Folliculitis
Official title: Effect of Cold Atmospheric Plasma on Malassezia Folliculitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malassezia Folliculitis
Keywords: Malassezia
Malassezia folliculitis
Cold atmospheric plasma
Pityrosporum folliculitis
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
Collaborators: name: Hefei CAS Ion Medical and Technical Devices Co.,Ltd
First posted: 2021-05-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 50% reduction in number of lesion
timeFrame: week 2
Secondary outcomes:
measure: proportion of subjects in physician's global assessment.
timeFrame: week 2
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Chunjun Yang
role: STUDY_CHAIR
affiliation: The Second Hospital of Anhui Medical University
name: Na Wang
role: STUDY_DIRECTOR
affiliation: The Second Hospital of Anhui Medical University
name: Jingwen Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Anhui Medical University
name: Jing Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Anhui Medical University
name: Liyun Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hald M, Arendrup MC, Svejgaard EL, Lindskov R, Foged EK, Saunte DM; Danish Society of Dermatology. Evidence-based Danish guidelines for the treatment of Malassezia-related skin diseases. Acta Derm Venereol. 2015 Jan;95(1):12-9. doi: 10.2340/00015555-1825.
citation: VON Woedtke T, Schmidt A, Bekeschus S, Wende K, Weltmann KD. Plasma Medicine: A Field of Applied Redox Biology. In Vivo. 2019 Jul-Aug;33(4):1011-1026. doi: 10.21873/invivo.11570.
citation: Wiegand C, Fink S, Hipler UC, Beier O, Horn K, Pfuch A, Schimanski A, Grunler B. Cold atmospheric pressure plasmas exhibit antimicrobial properties against critical bacteria and yeast species. J Wound Care. 2017 Aug 2;26(8):462-468. doi: 10.12968/jowc.2017.26.8.462.
citation: Gao J, Wang L, Xia C, Yang X, Cao Z, Zheng L, Ko R, Shen C, Yang C, Cheng C. Cold atmospheric plasma promotes different types of superficial skin erosion wounds healing. Int Wound J. 2019 Oct;16(5):1103-1111. doi: 10.1111/iwj.13161. Epub 2019 Jun 17.
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citation: Lee JW, Kim BJ, Kim MN. Photodynamic therapy: new treatment for recalcitrant Malassezia folliculitis. Lasers Surg Med. 2010 Feb;42(2):192-6. doi: 10.1002/lsm.20857.
citation: Abdel-Razek M, Fadaly G, Abdel-Raheim M, al-Morsy F. Pityrosporum (Malassezia) folliculitis in Saudi Arabia--diagnosis and therapeutic trials. Clin Exp Dermatol. 1995 Sep;20(5):406-9. doi: 10.1111/j.1365-2230.1995.tb01358.x.