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

NCT04367584 | Completed

• 1 other identifier: 18-09-1019
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

Acne lesion, Malassezia spp, skin microbiome, pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of fungal spore load based on microscopic examination

  Sample collected during subjects enrollment

• Presence and severity of pruritus

  Data collected during subjects enrollment

Study Arms (2)

Subjects with inflammatory AV lesions

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

Other: Clinical and laboratory examination

Subjects with non inflammatory AV lesions

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

Other: Clinical and laboratory examination

Interventions

Clinical and laboratory examination OTHER

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

Subjects with inflammatory AV lesions; Subjects with non inflammatory AV lesions

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Subjects with age of 15-49 years with AV and the presence of at least four inflammatory and four non-inflammatory lesions

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Acne Vulgaris; Pruritus

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Agassi Suseno Sutarjo, MD

  Department of Dermatology and Venereology, Tarakan General Hospital, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: October 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2018
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

ID (1)