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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03807453
Other study ID # IstanbulMU2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 25, 2019
Est. completion date June 18, 2019

Study information

Verified date September 2020
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 18, 2019
Est. primary completion date June 18, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Patients with scalp psoriasis

2. Patients with seborrheic dermatitis

3. Agree to participate in research 4 - Do not use any drugs for their disease topically or systemically for two months

Exclusion Criteria:

1. Patients who do not want to participate in the study

2. Patients with psoriasis vulgaris or seborrheic dermatitis that does not effect scalp.

3. Those with chronic diseases that may affect skin microbiome

4. Patients using antibiotics, antifungal or antiviral therapy for any reason for the last one month.

5. Patients who are using topical or systemic drugs for their illness

Study Design


Intervention

Other:
Microbiota
The scalp microbiota

Locations

Country Name City State
Turkey Melek Aslan Kayiran Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Istanbul Medeniyet University Turkish Dermatology Association

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
6 months
Secondary 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. 6 months
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