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| Name | Class |
|---|---|
| Hefei CAS Ion Medical and Technical Devices Co.,Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Itraconazole capsules treatment group | Active Comparator | Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold atmospheric plasma treatment device | Device | Treat with cold atmospheric plasma treatment device. |
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| Measure | Description | Time Frame |
|---|---|---|
| 50% reduction in number of lesion | proportion of subjects who achieve at least a 50% reduction in total number of lesions | week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of subjects in physician's global assessment. | proportion of subjects who achieve a physician's global assessment 0 / 1. | week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24556907 | Background | 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. | |
| 31280189 | 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. |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole Capsules | Drug | Treat with Itraconazole capsules |
|
| 28795887 | 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. |
| 31207094 | 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. |
| 20921630 | 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. |
| 20166153 | 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. |
| 8593718 | 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. |
| D010879 |
| Piperazines |