Characterization of Cutaneous Microbiota in the Psoriasis Pathogenesis (MICROBIOTA)

Characterization of Cutaneous Microbiota and Evaluation of the Antimicrobial Peptides Roles in the Psoriasis Etiopathogenesis

The skin harbors a complex and dynamic microbiota constituted by numerous microorganisms that live in symbiosis with the host. The specific etiology of psoriasis is still not-well understood; nonetheless several studies highlighted that that the skin microbiota could have a pivotal role in the maintenance and/or progression of the disease, acting as microbial predictor of psoriasis however.

The aim of the present study was to characterize the microbiota of cutaneous biopsies associated to guttate and vulgaris psoriasis, both considering lesion and healthy skin belonging to the same psoriatic subject.

Study Overview

• Status: Completed
• Conditions: Psoriasis

Detailed Description

Twelve individuals with guttate psoriasis and 12 individuals with vulgaris psoriasis have been enrolled at Dermatological Unit of IRCCS Galeazzi Institute, Milan.

Patients selected for the psoriasis vulgaris group had a course of disease stable for at least 1 month before collection. The second group presented guttate psoriasis, defined as "eruptive", that is characterized by a rapid appearance and worsening of the clinical presentation within the month preceding the visit.

From each participant, a punch was used to obtain a cutaneous sample from both a lesion and healthy skin area of 2 mm2 belonging to the left gluteus, for a total of 48 biological samples. Participants were selected and included in the study according to the following criteria: i) over 18 years of age; ii) use of a free-preservatives soap with moisturizing function; iii) no use of probiotics; iv) no use of antibiotics; v) no treatment with corticosteroids, biological drugs, methotrexate or retinoids in the month prior the sampling; vi) no use of topical corticosteroids, vitamin D derivatives or phototherapy; vi) no chronic or systemic infections; vii) no cutaneous acute infections; viii) no allergy to pollen, food and drugs ix) no pets. Informed consent was obtained from all subjects.

A metagenomics approach, performed by the use of Ion torrent Personal machine, were used to investigate the bacterial composition of the skin microbiota associated to each samples collected.

After sequencing, the data analysis were focused on the bacterial biodiversity and microbial networks existing in the skin microbiota to evaluate a hypothetical role of bacteria in the complex pathophysiological mechanisms involved in psoriasis.

• Study Type: Observational
• Enrollment (Actual): 24

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Twelve individuals with guttate psoriasis and 12 individuals with vulgaris psoriasis have been enrolled at Dermatological Unit of IRCCS Galeazzi Institute, Milan.

Patients selected for the psoriasis vulgaris group had a course of disease stable for at least 1 month before collection. The second group presented guttate psoriasis, defined as "eruptive", that is characterized by a rapid appearance and worsening of the clinical presentation within the month preceding the visit.

Description

Inclusion Criteria:

• over 18 years of age;
• use of a free-preservatives soap with moisturizing function, applied once a day;pets.

Exclusion Criteria:

• no use of probiotics in the month prior the sampling;
• no use of antibiotics in the month prior the sampling;
• no treatment with corticosteroids, biological drugs, methotrexate or retinoids in the month prior the sampling;
• no use of topical corticosteroids, vitamin D derivatives or phototherapy in the month prior the sampling;
• no chronic or systemic infections;
• no cutaneous acute infections during sampling;
• no allergy to pollen, food and drugs
• no pets.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Psoriasis vulgaris; Pathological conditions stable for at least 1 month before collection. One punch biopsy from each patient, was taken from a big reddish and scaly plaque and another punch biopsy from the perilesional healthy skin.
Psoriasis guttate; One punch biopsy from each patient, was taken from a small reddish and scaly plaque and another punch biopsy from the perilesional healthy skin.
Healthy skin of psoriasis vulgaris; Healthy skin area of 2mm2 belonging to the left gluteus from patients affected by psoriasis vulgaris
Healthy skin of psoriasis guttate; Healthy skin area of 2mm2 belonging to the left gluteus rom patients affected by psoriasis guttate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Psoriasis Area and Severity Index (PASI)	It is a measurement of psoriasis severity .	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chao's index	It is a measure of bacterial biodiversity	1 year
Microbial abundance	It is a measure of bacterial amount	1 year
Spearman's correlation	It a measure of the bacterial interactions	1 year
Shannon's index	It is a measure of bacterial biodiversity	At the beginning of the study
Simpson's index	It is a measure of bacterial biodiversity	1 year

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2016
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): November 21, 2017

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Psoriasis Guttate, Psoriasis vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: Microbiota

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No