Psoriasis VulgarisNCT03807453
Comparison of Scalp Microbiota of the Psoriasis and Seborrheic Dermatitis Patients
An observational study of Psoriasis Vulgaris and Seborrheic Dermatitis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
A sterile swap specimen taken from the scalp of the patients with psoriasis vulgaris or seborrheic dermatitis and the volunteer control group will be examined in our study. The examples of the microbiota of the patients will be taken both the lesional scalp and the lesion-free part of the scalp. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis Vulgaris, Seborrheic Dermatitis, Microbial Colonization
- What is being tested?
- Microbiota
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2019to 18 Jun 2019
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: primary care clinic and community sample
Who may be able to join
- Patients with scalp psoriasis
- Patients with seborrheic dermatitis
- Agree to participate in research 4 - Do not use any drugs for their disease topically or systemically for two months
Who cannot join
- Patients who do not want to participate in the study
- Patients with psoriasis vulgaris or seborrheic dermatitis that does not effect scalp.
- Those with chronic diseases that may affect skin microbiome
- Patients using antibiotics, antifungal or antiviral therapy for any reason for the last one month.
- Patients who are using topical or systemic drugs for their illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Scalp Microbiota of the Patients With Psoriasis Vulgaris and Seborrheic Dermatitis
A sterile swap specimen taken from the scalp of the patients with psoriasis vulgaris or seborrheic dermatitis and the volunteer control group will be examined in our study. The examples of the microbiota of the patients will be taken both the lesional scalp and the lesion-free part of the scalp. Then, the microbiota differences between the lesioned scalp and the lesion-free scalp of both groups, and the microbiome differences between the two groups and the control group will be evaluated.
- Being tested
- Microbiota
- Keywords
- Psoriasis Vulgaris, Seborrheic Dermatitis, Scalp, Microbiome
- Medical subject headings
- Dermatitis, Seborrheic, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrobiotaOther
The scalp microbiota
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis Vulgaris patients-Lesion | Not described Receives: Other: Microbiota | |
| Psoriasis Vulgaris patients-Lesion free | Not described Receives: Other: Microbiota | |
| Seborrheic Dermatitis-Lesion | Not described Receives: Other: Microbiota | |
| Seborrheic Dermatitis-Lesion free | Not described Receives: Other: Microbiota | |
| Control Group | Not described Receives: Other: Microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
The scalp microbiota of the patients with psoriasis and seborrheic dermatitis
The aim of this study is to compare the scalp microbiota of psoriasis vulgaris and seborrheic dermatitis both the lesion and lesion-free parts and also the control group and to assess their role on etiopathogenesis. Determining the microbiota of this region which is frequently involved and resistant to treatment may change the treatment approach. In addition, scalp microbiome of seborrheic dermatitis may be a causal factor of rapid relapse after treatment.
The similarities between the microbiota of the psoriasis vulgaris and seborrheic dermatitis cases with only scalp involvement can guide us not only for the diagnosis but also the treatment. There are a few reports about the role of Malassezia subgroups in the pathogenesis, but it is known that there are many different flora members on the scalp. Exposing these can change both our diagnosis and treatment options.
Measured: 6 months
Secondary outcomes (1)
The differences between the scalp microbiota of different countries
Does the microbiota of the patients change between the countries? To our knowledge, there is no similar studies in present. Presenting the scalp microbiome of Turkish population can be a start to understand whether there is a difference in terms of the countries.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start25 Apr 2019
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Dermatology Association
- Responsible party
- Principal investigator, Melek Aslan Kayıran, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807453
- Sponsor's protocol ID
- IstanbulMU2
- Status last verified
- Sep 2020
- First submitted
- 5 Jan 2019
- Last updated
- 10 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Scalp Microbiota of the Patients With Psoriasis Vulgaris and Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT03807453
- Acronym / sponsor ID
- IstanbulMU2
- Keywords
- Psoriasis Vulgaris, Seborrheic Dermatitis, Scalp, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Turkish Dermatology Association
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 17 Jan 2019 (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.
A sterile swap specimen taken from the scalp of the patients with psoriasis vulgaris or seborrheic dermatitis and the volunteer control group will be examined in our study. The examples of the microbiota of the patients will be taken both the lesional scalp and the lesion-free part of the scalp. Then, the microbiota differences between the lesioned scalp and the lesion-free scalp of both groups, and the microbiome differences between the two groups and the control group will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Psoriasis Vulgaris patients-Lesion | – | Other: Microbiota |
| Psoriasis Vulgaris patients-Lesion free | – | Other: Microbiota |
| Seborrheic Dermatitis-Lesion | – | Other: Microbiota |
| Seborrheic Dermatitis-Lesion free | – | Other: Microbiota |
| Control Group | – | Other: Microbiota |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- primary care clinic and community sample
Key inclusion criteria (3 listed)
- Patients with scalp psoriasis
- Patients with seborrheic dermatitis
- Agree to participate in research 4 - Do not use any drugs for their disease topically or systemically for two months
Key exclusion criteria (5 listed)
- Patients who do not want to participate in the study
- Patients with psoriasis vulgaris or seborrheic dermatitis that does not effect scalp.
- Those with chronic diseases that may affect skin microbiome
- Patients using antibiotics, antifungal or antiviral therapy for any reason for the last one month.
- Patients who are using topical or systemic drugs for their illness
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 |
|---|---|---|
| MicrobiotaThe scalp microbiota | Other | Control Group, Psoriasis Vulgaris patients-Lesion, Psoriasis Vulgaris patients-Lesion free, Seborrheic Dermatitis-Lesion, Seborrheic Dermatitis-Lesion free |
Primary outcome
The scalp microbiota of the patients with psoriasis and seborrheic dermatitis
Time frame: 6 months
The aim of this study is to compare the scalp microbiota of psoriasis vulgaris and seborrheic dermatitis both the lesion and lesion-free parts and also the control group and to assess their role on etiopathogenesis. Determining the microbiota of this region which is frequently involved and resistant to treatment may change the treatment approach. In addition, scalp microbiome of seborrheic dermatitis may be a causal factor of rapid relapse after treatment. The similarities between the microbiota of the psoriasis vulgaris and seborrheic dermatitis cases with only scalp involvement can guide us not only for the diagnosis but also the treatment. There are a few reports about the role of Malassezia subgroups in the pathogenesis, but it is known that there are many different flora members on the scalp. Exposing these can change both our diagnosis and treatment options.
1 secondary outcome
The differences between the scalp microbiota of different countries
Time frame: 6 months
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 10 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Psoriasis Vulgaris and Seborrheic Dermatitis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 10 Sep 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 Turkey (Türkiye). 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?
The scalp microbiota of the patients with psoriasis and seborrheic dermatitis (time frame: 6 months). 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 10 Sep 2020.