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Effect of Cold Atmospheric Plasma on Malassezia Folliculitis (ECAPMF)

Primary Purpose

Malassezia Folliculitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cold atmospheric plasma treatment device
Itraconazole Capsules
Sponsored by
The Second Hospital of Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malassezia Folliculitis focused on measuring Malassezia, Malassezia folliculitis, Cold atmospheric plasma, Pityrosporum folliculitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Hospital of Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cold atmospheric plasma treatment group

Itraconazole capsules treatment group

Arm Description

Patients are treated with a plasma device. Each treatment time was 3min/cm2 based on the skin lesion area.The frequency of treatment is once a day. The duration of the treatment period is 1-2weeks.

Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 1-2weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportionof subjects in Investigator global assessment (IGA)
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale.

Full Information

First Posted
April 27, 2021
Last Updated
September 20, 2022
Sponsor
The Second Hospital of Anhui Medical University
Collaborators
Hefei CAS Ion Medical and Technical Devices Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04886323
Brief Title
Effect of Cold Atmospheric Plasma on Malassezia Folliculitis
Acronym
ECAPMF
Official Title
Effect of Cold Atmospheric Plasma on Malassezia Folliculitis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Anhui Medical University
Collaborators
Hefei CAS Ion Medical and Technical Devices Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malassezia Folliculitis
Keywords
Malassezia, Malassezia folliculitis, Cold atmospheric plasma, Pityrosporum folliculitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cold atmospheric plasma treatment group
Arm Type
Experimental
Arm Description
Patients are treated with a plasma device. Each treatment time was 3min/cm2 based on the skin lesion area.The frequency of treatment is once a day. The duration of the treatment period is 1-2weeks.
Arm Title
Itraconazole capsules treatment group
Arm Type
Active Comparator
Arm Description
Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 1-2weeks.
Intervention Type
Device
Intervention Name(s)
Cold atmospheric plasma treatment device
Intervention Description
Treat with cold atmospheric plasma treatment device.
Intervention Type
Drug
Intervention Name(s)
Itraconazole Capsules
Intervention Description
Treat with Itraconazole capsules
Primary Outcome Measure Information:
Title
50% reduction in number of lesion
Description
proportion of subjects who achieve at least a 50% reduction in total number of inflammatory lesions
Time Frame
week 1 and 2
Secondary Outcome Measure Information:
Title
Proportionof subjects in Investigator global assessment (IGA)
Description
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale.
Time Frame
Baseline to week 1 and 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunjun Yang
Phone
+86-551-63869448
Email
yangchunjun9@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Na Wang
Phone
+86-15155969071
Email
wangnaay2fy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunjun Yang
Organizational Affiliation
The Second Hospital of Anhui Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Na Wang
Organizational Affiliation
The Second Hospital of Anhui Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jingwen Wang
Organizational Affiliation
The Second Hospital of Anhui Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Gao
Organizational Affiliation
The Second Hospital of Anhui Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liyun Wang
Organizational Affiliation
The Second Hospital of Anhui Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunjun Yang
Phone
+86-551-63869448

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24556907
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.
Results Reference
background
PubMed Identifier
31280189
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.
Results Reference
background
PubMed Identifier
28795887
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.
Results Reference
background
PubMed Identifier
31207094
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.
Results Reference
background
PubMed Identifier
20921630
Citation
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.
Results Reference
background
PubMed Identifier
20166153
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.
Results Reference
background
PubMed Identifier
8593718
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.
Results Reference
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Effect of Cold Atmospheric Plasma on Malassezia Folliculitis

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