NCT04886323|Completed
Effect of Cold Atmospheric Plasma on Malassezia Folliculitis
ECAPMF
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ECAPMF
Sponsor study identifier
interventional
50
1 country
1
Study Start
August 3, 2022
Actual (reported)Primary Completion
December 17, 2023
Actual (reported)Study Completion
December 17, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 17, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2021
Actual (reported)May 14, 2021
Actual (reported)August 3, 2022
Actual (reported)December 17, 2023
Actual (reported)December 17, 2023
Actual (reported)50% reduction in number of lesion
proportion of subjects who achieve at least a 50% reduction in total number of lesions
week 2
proportion of subjects in physician's global assessment.
week 2
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.
Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks.
Treat with cold atmospheric plasma treatment device.
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
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.
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.
Chunjun Yang
The Second Hospital of Anhui Medical University
Na Wang
The Second Hospital of Anhui Medical University
Jingwen Wang
The Second Hospital of Anhui Medical University
Jing Gao
The Second Hospital of Anhui Medical University
50 participants (actual enrollment reported by the registry).
First Submitted
April 27, 2021
First Posted
May 14, 2021
Study Start
August 3, 2022
Actual (reported)Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
Liyun Wang
The Second Hospital of Anhui Medical University
Primary Completion
December 17, 2023
Actual (reported)Study Completion
December 17, 2023
Actual (reported)Last Updated
December 26, 2023
Record last verified: 2023-12
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