NCT03807453

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

January 5, 2019

Last Update Submit

September 8, 2020

Conditions

Keywords

Psoriasis VulgarisSeborrheic DermatitisScalpMicrobiome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The differences between the scalp microbiota of different countries

    6 months

Study Arms (5)

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

Interventions

The scalp microbiota

Control GroupPsoriasis Vulgaris patients-LesionPsoriasis Vulgaris patients-Lesion freeSeborrheic Dermatitis-LesionSeborrheic Dermatitis-Lesion free

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic and community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melek Aslan Kayıran

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dermatitis, SeborrheicCommunicable Diseases

Interventions

Microbiota

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesSkin Diseases, EczematousSkin Diseases, PapulosquamousInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist, M.D.

Study Record Dates

First Submitted

January 5, 2019

First Posted

January 17, 2019

Study Start

April 25, 2019

Primary Completion

June 18, 2019

Study Completion

June 18, 2019

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations