Viewing Study NCT04367584



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Last Modification Date: 2024-10-26 @ 1:34 PM
Study NCT ID: NCT04367584
Status: COMPLETED
Last Update Posted: 2020-05-01
First Post: 2020-04-27

Brief Title: Comparison of Malassezia Spp Proportions in Inflammatory and Non Inflammatory Facial Acne Vulgaris Lesions
Sponsor: Indonesia University
Organization: Indonesia University

Study Overview

Official Title: Comparison of Malassezia Spp Proportions in Inflammatory and Non Inflammatory Facial Acne Vulgaris Lesions
Status: COMPLETED
Status Verified Date: 2020-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None