Malassezia FolliculitisECAPMFNCT04886323
Effect of Cold Atmospheric Plasma on Malassezia Folliculitis
A study testing Cold atmospheric plasma treatment device and Itraconazole Capsules in people with Malassezia Folliculitis, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malassezia Folliculitis
- What is being tested?
- Cold atmospheric plasma treatment device and Itraconazole Capsules
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2022to 17 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000
About this study
Official title: Effect of Cold Atmospheric Plasma on Malassezia Folliculitis: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Malassezia Folliculitis
- Being tested
- Cold atmospheric plasma treatment device, Itraconazole Capsules
- Keywords
- Malassezia, Malassezia folliculitis, Cold atmospheric plasma, Pityrosporum folliculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold atmospheric plasma treatment deviceDevice
Treat with cold atmospheric plasma treatment device.
Itraconazole CapsulesDrug
Treat with Itraconazole capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Itraconazole Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% reduction in number of lesion
proportion of subjects who achieve at least a 50% reduction in total number of lesions
Measured: week 2
Secondary outcomes (1)
proportion of subjects in physician's global assessment.
proportion of subjects who achieve a physician's global assessment 0 / 1.
Measured: week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start3 Aug 2022
- Primary completion17 Dec 2023
- Study completion17 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Malassezia FolliculitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Hefei CAS Ion Medical and Technical Devices Co.,Ltd
- Responsible party
- Principal investigator, Yang chunjun, The Second Hospital of Anhui Medical University
- Investigators
- Chunjun Yang, Study chair, The Second Hospital of Anhui Medical UniversityNa Wang, Study director, The Second Hospital of Anhui Medical UniversityJingwen Wang, Principal investigator, The Second Hospital of Anhui Medical UniversityJing Gao, Principal investigator, The Second Hospital of Anhui Medical UniversityLiyun Wang, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886323
- Sponsor's protocol ID
- YX2021-028
- Acronym
- ECAPMF
- Status last verified
- Dec 2023
- First submitted
- 27 Apr 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24556907VON 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.
PubMed 31280189Wiegand 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.
PubMed 28795887Gao 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.
PubMed 31207094Parsad 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.
PubMed 20921630Lee 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.
PubMed 20166153Abdel-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.
PubMed 8593718
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cold Atmospheric Plasma on Malassezia Folliculitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04886323
- Acronym / sponsor ID
- ECAPMF / YX2021-028
- Conditions
- Malassezia Folliculitis
- Keywords
- Malassezia, Malassezia folliculitis, Cold atmospheric plasma, Pityrosporum folliculitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Hefei CAS Ion Medical and Technical Devices Co.,Ltd
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 17 Dec 2023 (actual)
- Study completion
- 17 Dec 2023 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold atmospheric plasma treatment group | Experimental | Device: Cold atmospheric plasma treatment devicePatients 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 | Drug: Itraconazole CapsulesPatients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold atmospheric plasma treatment deviceTreat with cold atmospheric plasma treatment device. | Device | cold atmospheric plasma treatment group |
| Itraconazole CapsulesTreat with Itraconazole capsules | Drug | Itraconazole capsules treatment group |
Primary outcome
50% reduction in number of lesion
Time frame: week 2
proportion of subjects who achieve at least a 50% reduction in total number of lesions
1 secondary outcome
proportion of subjects in physician's global assessment.
Time frame: week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Background: PubMed 24556907Hald 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.
- Background: PubMed 31280189VON 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.
- Background: PubMed 28795887Wiegand 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.
- Background: PubMed 31207094Gao 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.
- Background: PubMed 20921630Parsad 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.
- Background: PubMed 20166153Lee 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.
- Background: PubMed 8593718Abdel-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunjun Yang study chair
The Second Hospital of Anhui Medical University
Na Wang study director
The Second Hospital of Anhui Medical University
Jingwen Wang principal investigator
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold atmospheric plasma treatment device and Itraconazole Capsules in people with Malassezia Folliculitis, run by The Second Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% reduction in number of lesion (time frame: week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886323, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.