ECAPMF: Effect of Cold Atmospheric Plasma on Malassezia Folliculitis
Study Details
Study Description
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 topical antifungal drugs. The differences of treatment effects of the two groups will be observed and compared.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: cold atmospheric plasma treatment group Patients are treated with a plasma device. Each treatment time was 5min/cm2 based on the skin lesion area.The frequency of treatment is once every two days. The duration of the treatment period is 1-4weeks. |
Device: Cold atmospheric plasma treatment device
Treat with cold atmospheric plasma treatment device.
|
| Active Comparator: 2% ketoconazole cream treatment group Patients are treated with 2% ketoconazole cream, twice a day.The duration of the treatment period is 1-4weeks. |
Drug: 2% ketoconazole cream
Treat with 2% ketoconazole cream.
|
Outcome Measures
Primary Outcome Measures
- Proportions of patients with different degrees of clinical improvement after treatment. [60 days.]
Evaluate clinical improvement by comparing lesions prior to treatment (baseline) and after the treatment. Measurement: Two blinded dermatologists evaluated clinical improvement by comparing digital photographs taken prior to treatment (baseline) and after the treatment using a five-point scale (-1,worsening; 0,no change; 1, mild improvement <33%; 2, moderate improvement 34-66%; 3, strong improvement > 67%). Proportions of patients with different degrees of clinical improvement after treatment will be calculated.
Secondary Outcome Measures
- Proportion of Malassezia spore load based on microscopic examination. [60 days.]
Proportion of Malassezia spore load of the material scraped from the lesions (papules, molluscoid lesions and pustules) based on microscopic examination graded using Jacinto Jamora criteria.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients are clinical presentation of Malassezia folliculitis in seborrheic areas.
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The diagnoses are mycologically verified by experienced laboratory technicians.
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Participants must be informed of the investigational nature of this study and be willing to provide written informed consent.
Exclusion Criteria:
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Combined with other serious systemic diseases.
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History of topical corticosteroids within 2 weeks or history of systemic corticosteroids within 1 month.
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History of immunosuppressive drugs within 1 month.
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History of topical antifungal medication within 2 weeks or systemic antifungal medication within 3 months.
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Pregnant and lactating women.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Second Hospital of Anhui Medical University
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Review.
- 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.
- 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.
- 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. Review.
- Wiegand C, Fink S, Hipler UC, Beier O, Horn K, Pfuch A, Schimanski A, Grünler 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.
- YX2021-028