Phenotypic and Genotypic Characterization of Malassezia Species Isolated From Malassezia Associated Skin Diseases

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:

1. Phenotypic and Genotypic Characterization of Malassezia Species.
2. Identify antifungal resistance pattern among isolated fungus.

Study Overview

• Status: Not yet recruiting
• Conditions: Malassezia Infection
• Intervention / Treatment: Diagnostic test: culture and antifungal sensitivity and molecular detection

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Mai m Abozaid, Demonstrator; Phone Number: 01020773233; Email: maimohamed@med.sohag.edu.eg
• Study Contact Backup: Name: Nessma A Mohamed, lecturer; Phone Number: 01006780725; Email: nesmaaateef@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
case	Diagnostic test: culture and antifungal sensitivity and molecular detection; 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
control	Diagnostic test: culture and antifungal sensitivity and molecular detection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of malassezia in patients	frequency of malassezia in patients with malassezia associated skin infection	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General 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.
• Gaitanis 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.
• Lee 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.
• Lyakhovitsky 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Antifungal Agents; Clotrimazole; Miconazole
• Other Study ID Numbers: soh-Med-22-07-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No