Clinical trial NCT04367584: Comparison of Malassezia Spp Proportions in Inflammatory and Non Inflammatory Facial Acne Vulgaris Lesions
Official title: Comparison of Malassezia Spp Proportions in Inflammatory and Non Inflammatory Facial Acne Vulgaris Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Keywords: Acne lesion, Malassezia spp, skin microbiome, pruritus
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Malassezia spp. from culture examination
timeFrame: Sample collected during subjects enrollment
Secondary outcomes:
measure: Proportion of fungal spore load based on microscopic examination
timeFrame: Sample collected during subjects enrollment
measure: Presence and severity of pruritus
timeFrame: Data collected during subjects enrollment
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
state: DKI Jakarta
Study officials:
affiliation: Department of Dermatology and Venereology, Tarakan General Hospital, Indonesia
name: Agassi Suseno Sutarjo, MD
role: PRINCIPAL_INVESTIGATOR
References: