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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367584
• Other study ID #: 18-09-1019
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 30, 2018
• Est. primary completion date: November 30, 2018
• Gender: All
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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