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Completed

NCT Number: NCT04367584

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Pathological Conditions, Signs and Symptoms Pruritus Sebaceous Gland Diseases Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

15 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical and laboratory examination

Other

Clinical and laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture)

Primary outcomes

  1. Proportion of Malassezia spp. from culture examination

    Time frame: Sample collected during subjects enrollment

    Proportion of Malassezia spp. from culture of inflammatory and non-inflammatory facial AV lesions

Secondary outcomes

  1. Proportion of fungal spore load based on microscopic examination

    Time frame: Sample collected during subjects enrollment

    Proportion of fungal spore load of inflammatory and non-inflammatory facial AV lesions based on microscopic examination graded using Jacinto Jamora criteria

  2. Presence and severity of pruritus

    Time frame: Data collected during subjects enrollment

    Presence and severity of pruritus graded using visual analog scale in correlation with the presence of Malassezia spp and its spore load

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2020
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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