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

NCT ID: NCT04367584

Last Updated: 2020-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2018-12-30

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects with inflammatory AV lesions

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

Clinical and laboratory examination

Intervention Type OTHER

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)

Clinical and laboratory examination

Intervention Type OTHER

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

Interventions

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Clinical and laboratory examination

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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dr. Agassi Suseno Sutarjo, SpKK

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agassi Suseno Sutarjo, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology and Venereology, Tarakan General Hospital, Indonesia

Locations

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Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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18-09-1019

Identifier Type: -

Identifier Source: org_study_id

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