Acne VulgarisNCT04367584
Comparison of Malassezia Spp Proportions in Inflammatory and Non Inflammatory Facial Acne Vulgaris Lesions
An observational study of Acne Vulgaris, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Clinical and laboratory examination
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2018to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- All sexes
- Child, Adult
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.
Who may be able to join
- Subjects with age of 15-49 years with AV and the presence of at least four inflammatory and four non-inflammatory lesions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Clinical and laboratory examination
- Keywords
- Acne lesion, Malassezia spp, skin microbiome, pruritus
- Medical subject headings
- Acne Vulgaris, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and laboratory examinationOther
Clinical and laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture)
| Study group | Role | What they receive |
|---|---|---|
| Subjects with inflammatory AV lesions | Clinical examination Laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture) Receives: 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) Receives: Other: Clinical and laboratory examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Malassezia spp. from culture examination
Proportion of Malassezia spp. from culture of inflammatory and non-inflammatory facial AV lesions
Measured: Sample collected during subjects enrollment
Secondary outcomes (2)
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
Measured: Sample collected during subjects enrollment
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
Measured: Data collected during subjects enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Oct 2018
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Agassi Suseno Sutarjo, SpKK, Universitas Indonesia
- Investigators
- Agassi Suseno Sutarjo, MD, Principal investigator, Department of Dermatology and Venereology, Tarakan General Hospital, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367584
- Sponsor's protocol ID
- 18-09-1019
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Malassezia Spp Proportions in Inflammatory and Non Inflammatory Facial Acne Vulgaris Lesions
- ClinicalTrials.gov ID
- NCT04367584
- Acronym / sponsor ID
- 18-09-1019
- Conditions
- Acne Vulgaris
- Keywords
- Acne lesion, Malassezia spp, skin microbiome, pruritus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with inflammatory AV lesions | – | Other: Clinical and laboratory examinationClinical examination Laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture) |
| Subjects with non inflammatory AV lesions | – | Other: Clinical and laboratory examinationClinical examination Laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture) |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Subjects with age of 15-49 years with AV and the presence of at least four inflammatory and four non-inflammatory lesions
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and laboratory examinationClinical and laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture) | Other | Subjects with inflammatory AV lesions, Subjects with non inflammatory AV lesions |
Primary outcome
Proportion of Malassezia spp. from culture examination
Time frame: Sample collected during subjects enrollment
Proportion of Malassezia spp. from culture of inflammatory and non-inflammatory facial AV lesions
2 secondary outcomes
Proportion of fungal spore load based on microscopic examination
Time frame: Sample collected during subjects enrollment
Presence and severity of pruritus
Time frame: Data collected during subjects enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agassi Suseno Sutarjo, MD principal investigator
Department of Dermatology and Venereology, Tarakan General Hospital, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Malassezia spp. from culture examination (time frame: Sample collected during subjects enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.