Malassezia InfectionNCT05476731
Phenotypic and Genotypic Characterization of Malassezia Species Isolated From Malassezia Associated Skin Diseases
An observational study of Malassezia Infection, run by Sohag University at 1 site in Egypt.
Trial summary
Genus Malassezia includes 14 species, namely M. furfur, M. sympodialis, M. globosa, M. restricta, M. slooffiae, M. obtusa, M. dermatis, M. japonica and M. yamatoensis associated with normal human flora but can also cause skin lesions, and M. pachydermatis, M. nana, M. equina, M. caprae and M. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malassezia Infection
- What is being tested?
- culture and antifungal sensitivity and molecular detection
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2022to Feb 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Characteristic lesions of hypopigmented or hyperpigmented scaly macules and patches which may be associated with itching in patients with Pityriasis versicolor and scales of Seborrheic dermatitis and scales from patients with Atopic dermatitis.
Who may be able to join
- Characteristic lesions of hypopigmented or hyperpigmented scaly macules and patches which may be associated with itching in patients with Pityriasis versicolor and scales of Seborrheic dermatitis and scales from patients with Atopic dermatitis.
Who cannot join
- Patients with skin lesions of extensive desquamation or inflammation that do not match Pityriasis versicolor , Seborrheic dermatitis or Atopic dermatitis. Patients who had received topical antifungal therapy within last three months or oral antifungal therapy within the last six months
Trial locations and contacts
1 site in 1 country.
About this study
Genus Malassezia includes 14 species, namely M. furfur, M. sympodialis, M. globosa, M. restricta, M. slooffiae, M. obtusa, M. dermatis, M. japonica and M. yamatoensis associated with normal human flora but can also cause skin lesions, and M. pachydermatis, M. nana, M. equina, M. caprae and M. cuniculiare associated with animals. Few studies found that M. pachydermatis may be transmitted to humans from pets. M. pachydermmatis is the only lipid independent species while others are lipid dependent .
As Malassezia species have similar morphological and biochemical features, the currently used phenotypic techniques for diagnosis of Pityriasis versicolor usually do not allow rapid and exact characterization. In addition; they are time-consuming, multi-step processes requiring several experimental methods. Therefore, several molecular typing methods have been used successfully, resulting in identification and classification of new Malassezia species
Read more
Aim of the work:
- Phenotypic and Genotypic Characterization of Malassezia Species.
- Identify antifungal resistance pattern among isolated fungus.
- Conditions
- Malassezia Infection
- Being tested
- culture and antifungal sensitivity and molecular detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culture and antifungal sensitivity and molecular detectionDiagnostic test
Samples will be cultured on Modified Dixon media for 10 days at temperature between 32-34°C.Molecular detection of malassezia species by Restriction Fragment Length Polymorphism (RFLP) .
Antifungal susceptibility testing of the isolates will be performed using the following antifungals Fluconazole, AmphotericinB and Fluocytosine
| Study group | Role | What they receive |
|---|---|---|
| case | Not described Receives: Diagnostic Test: culture and antifungal sensitivity and molecular detection | |
| control | Not described Receives: Diagnostic Test: culture and antifungal sensitivity and molecular detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of malassezia in patients
frequency of malassezia in patients with malassezia associated skin infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Malassezia InfectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Abozaid, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476731
- Sponsor's protocol ID
- soh-Med-22-07-08
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Angiolella L, Carradori S, Maccallini C, Giusiano G, Supuran CT. Targeting Malassezia species for Novel Synthetic and Natural Antidandruff Agents. Curr Med Chem. 2017;24(22):2392-2412. doi: 10.2174/0929867324666170404110631.
PubMed 28393697Gaitanis G, Magiatis P, Hantschke M, Bassukas ID, Velegraki A. The Malassezia genus in skin and systemic diseases. Clin Microbiol Rev. 2012 Jan;25(1):106-41. doi: 10.1128/CMR.00021-11.
PubMed 22232373Lee YW, Byun HJ, Kim BJ, Kim DH, Lim YY, Lee JW, Kim MN, Kim D, Chun YJ, Mun SK, Kim CW, Kim SE, Hwang JS. Distribution of malassezia species on the scalp in korean seborrheic dermatitis patients. Ann Dermatol. 2011 May;23(2):156-61. doi: 10.5021/ad.2011.23.2.156. Epub 2011 May 27.
PubMed 21747613Lyakhovitsky A, Shemer A, Amichai B. Molecular analysis of Malassezia species isolated from Israeli patients with pityriasis versicolor. Int J Dermatol. 2013 Feb;52(2):231-3. doi: 10.1111/j.1365-4632.2012.05595.x.
PubMed 23347312
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic Characterization of Malassezia Species Isolated From Malassezia Associated Skin Diseases
- ClinicalTrials.gov ID
- NCT05476731
- Acronym / sponsor ID
- soh-Med-22-07-08
- Conditions
- Malassezia Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 27 Jul 2022 (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.
Genus Malassezia includes 14 species, namely M. furfur, M. sympodialis, M. globosa, M. restricta, M. slooffiae, M. obtusa, M. dermatis, M. japonica and M. yamatoensis associated with normal human flora but can also cause skin lesions, and M. pachydermatis, M. nana, M. equina, M. caprae and M. cuniculiare associated with animals. Few studies found that M. pachydermatis may be transmitted to humans from pets. M. pachydermmatis is the only lipid independent species while others are lipid dependent .
As Malassezia species have similar morphological and biochemical features, the currently used phenotypic techniques for diagnosis of Pityriasis versicolor usually do not allow rapid and exact characterization. In addition; they are time-consuming, multi-step processes requiring several experimental methods. Therefore, several molecular typing methods have been used successfully, resulting in identification and classification of new Malassezia species
Aim of the work:
- Phenotypic and Genotypic Characterization of Malassezia Species.
- Identify antifungal resistance pattern among isolated fungus.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Diagnostic Test: culture and antifungal sensitivity and molecular detection |
| control | – | Diagnostic Test: culture and antifungal sensitivity and molecular detection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Characteristic lesions of hypopigmented or hyperpigmented scaly macules and patches which may be associated with itching in patients with Pityriasis versicolor and scales of Seborrheic dermatitis and scales from patients with Atopic dermatitis.
Key inclusion criteria (1 listed)
- Characteristic lesions of hypopigmented or hyperpigmented scaly macules and patches which may be associated with itching in patients with Pityriasis versicolor and scales of Seborrheic dermatitis and scales from patients with Atopic dermatitis.
Key exclusion criteria (1 listed)
- Patients with skin lesions of extensive desquamation or inflammation that do not match Pityriasis versicolor , Seborrheic dermatitis or Atopic dermatitis. Patients who had received topical antifungal therapy within last three months or oral antifungal therapy within the last six months
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 |
|---|---|---|
| culture and antifungal sensitivity and molecular detectionSamples will be cultured on Modified Dixon media for 10 days at temperature between 32-34°C.Molecular detection of malassezia species by Restriction Fragment Length Polymorphism (RFLP) . Antifungal susceptibility testing of the isolates will be performed using the following antifungals Fluconazole, AmphotericinB and Fluocytosine | Diagnostic test | case, control |
Primary outcome
frequency of malassezia in patients
Time frame: 6 months
frequency of malassezia in patients with malassezia associated skin infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Background: PubMed 28393697Angiolella L, Carradori S, Maccallini C, Giusiano G, Supuran CT. Targeting Malassezia species for Novel Synthetic and Natural Antidandruff Agents. Curr Med Chem. 2017;24(22):2392-2412. doi: 10.2174/0929867324666170404110631.
- Background: PubMed 22232373Gaitanis G, Magiatis P, Hantschke M, Bassukas ID, Velegraki A. The Malassezia genus in skin and systemic diseases. Clin Microbiol Rev. 2012 Jan;25(1):106-41. doi: 10.1128/CMR.00021-11.
- Background: PubMed 21747613Lee YW, Byun HJ, Kim BJ, Kim DH, Lim YY, Lee JW, Kim MN, Kim D, Chun YJ, Mun SK, Kim CW, Kim SE, Hwang JS. Distribution of malassezia species on the scalp in korean seborrheic dermatitis patients. Ann Dermatol. 2011 May;23(2):156-61. doi: 10.5021/ad.2011.23.2.156. Epub 2011 May 27.
- Background: PubMed 23347312Lyakhovitsky A, Shemer A, Amichai B. Molecular analysis of Malassezia species isolated from Israeli patients with pityriasis versicolor. Int J Dermatol. 2013 Feb;52(2):231-3. doi: 10.1111/j.1365-4632.2012.05595.x.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malassezia Infection, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai m Abozaid, Demonstrator (01020773233, maimohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of malassezia in patients (time frame: 6 months). 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 NCT05476731, which also lists 4 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 27 Jul 2022.