Effect of Cold Atmospheric Plasma on Malassezia Folliculitis

NCT04886323 | Completed

• 1 other identifier: YX2021-028
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Malassezia Folliculitis

Keywords

Malassezia; Malassezia folliculitis; Cold atmospheric plasma; Pityrosporum folliculitis

Outcome Measures

Primary Outcomes (1)

• 50% reduction in number of lesion

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

  week 2

Secondary Outcomes (1)

• proportion of subjects in physician's global assessment.

  week 2

Study Arms (2)

cold atmospheric plasma treatment group

EXPERIMENTAL

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

Itraconazole capsules treatment group

ACTIVE COMPARATOR

Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks.

Drug: Itraconazole Capsules

Interventions

Cold atmospheric plasma treatment device DEVICE

Treat with cold atmospheric plasma treatment device.

cold atmospheric plasma treatment group

Itraconazole Capsules DRUG

Treat with Itraconazole capsules

Itraconazole capsules treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead
• Hefei CAS Ion Medical and Technical Devices Co.,Ltd: collaborator

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

Related Publications (7)

• 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.

  PMID: 24556907 BACKGROUND

• 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.

  PMID: 31280189 BACKGROUND

• 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.

  PMID: 28795887 BACKGROUND

• 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.

  PMID: 31207094 BACKGROUND

• Parsad D, Saini R, Negi KS. Short term treatment of pityrosporum folliculitis with itraconazole. Indian J Dermatol Venereol Leprol. 1999 May-Jun;65(3):122-3.

  PMID: 20921630 BACKGROUND

• 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.

  PMID: 20166153 BACKGROUND

• 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.

  PMID: 8593718 BACKGROUND

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Chunjun Yang

  The Second Hospital of Anhui Medical University

  STUDY CHAIR

• Na Wang

  The Second Hospital of Anhui Medical University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Dermatology

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 14, 2021
• Study Start: August 3, 2022
• Primary Completion: December 17, 2023
• Study Completion: December 17, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)