Comparison of Malassezia Spp Proportions in Inflammatory and Non Inflammatory Facial Acne Vulgaris Lesions

Acne vulgaris (AV) is a common inflammatory condition involving pilosebaceous unit. The pathogenesis of acne is multifactorial and skin microbiome is considered to be one of the key factors that aggravate inflammation. Malassezia spp is normal flora on the skin and several studies have reported its corelation with inflammatory AV lesion.

Malassezia have higher lipase activity compared to Propionibacterium acnes which triggers an increase in free fatty acid and glycerol, the chemotactic factors towards neutrophils and inducing inflammation in AV. Malassezia folliculitis (MF) is sometimes confused with and may present together with AV. Pruritus usually presents in MF but some studies also reported itching as common symptom in AV.

The objectives of this study were to identify the presence and the distribution of Malassezia spp. in facial AV lesions, to compare the distribution of Malassezia spp. between inflammatory and non-inflammatory lesions and to identify the association between Malassezia spp in acne lesions and pruritus symptom.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: Clinical and laboratory examination

Detailed Description

This study used cross sectional design study.

Subjects with eligible criteria were included. Subjects were divided into subjects with inflammatory lesions and subjects with non inflammatory lesions.

Physical examination consisted of assesment of AV severity (using Lehman criteria) and presence of pruritus based on visual analog scale. Clinical documetations were taken.

Follicular content of four inflammatory lesions or four non inflammatory lesions were collected for microscopic examination with KOH solution and fungal culture examination (using CHROMagar Malassezia, Dextrose Saboraud agar (DSA), and Tween 60-esculin agar).

The presence of Malassezia spp and its spore load in both groups were assesed and analyzed for its corelation with AV severity and presence of pruritus.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with age of 15-49 years and the presence of at least four inflammatory and four non-inflammatory acne lesions at Dermatology-Venereology outpatient clinic in a tertiary hospital in Indonesia between October to November 2018.

Description

Inclusion Criteria:

• Subjects with age of 15-49 years with AV and the presence of at least four inflammatory and four non-inflammatory lesions

Exclusion Criteria:

• Subjects with prior topical retinoid acid or topical antifungal medication within the past two weeks, systemic antibiotic or antifungal use within the past month, and corticosteroid use within the past six months

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with inflammatory AV lesions; Clinical examination Laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture)	Other: Clinical and laboratory examination; Clinical and laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture)
Subjects with non inflammatory AV lesions; Clinical examination Laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture)	Other: Clinical and laboratory examination; Clinical and laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Malassezia spp. from culture examination	Proportion of Malassezia spp. from culture of inflammatory and non-inflammatory facial AV lesions	Sample collected during subjects enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of fungal spore load based on microscopic examination	Proportion of fungal spore load of inflammatory and non-inflammatory facial AV lesions based on microscopic examination graded using Jacinto Jamora criteria	Sample collected during subjects enrollment
Presence and severity of pruritus	Presence and severity of pruritus graded using visual analog scale in correlation with the presence of Malassezia spp and its spore load	Data collected during subjects enrollment

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Agassi Suseno Sutarjo, MD, Department of Dermatology and Venereology, Tarakan General Hospital, Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Acne lesion, Malassezia spp, skin microbiome, pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 18-09-1019

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