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Trial record 2 of 1709 for:    psoriasis

Characterization of Cutaneous Microbiota in the Psoriasis Pathogenesis (MICROBIOTA)

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ClinicalTrials.gov Identifier: NCT03475914
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Brief Summary:

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.


Condition or disease
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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 8 Months
Official Title: Characterization of Cutaneous Microbiota and Evaluation of the Antimicrobial Peptides Roles in the Psoriasis Etiopathogenesis
Actual Study Start Date : October 13, 2016
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : November 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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



Primary Outcome Measures :
  1. Evaluation of the Psoriasis Area and Severity Index (PASI) [ Time Frame: 1 year ]
    It is a measurement of psoriasis severity .


Secondary Outcome Measures :
  1. Chao's index [ Time Frame: 1 year ]
    It is a measure of bacterial biodiversity

  2. Microbial abundance [ Time Frame: 1 year ]
    It is a measure of bacterial amount

  3. Spearman's correlation [ Time Frame: 1 year ]
    It a measure of the bacterial interactions

  4. Shannon's index [ Time Frame: At the beginning of the study ]
    It is a measure of bacterial biodiversity

  5. Simpson's index [ Time Frame: 1 year ]
    It is a measure of bacterial biodiversity


Biospecimen Retention:   Samples With DNA
From each participant, a punch was used to obtain a cutaneous sample from both a lesioned and healthy skin area of 2 mm2 belonging t the left gluteus, for a total of 48 biological samples.


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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.

Criteria

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.

Additional Information:

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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03475914     History of Changes
Other Study ID Numbers: MICROBIOTA
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Ortopedico Galeazzi:
Psoriasis Guttate, Psoriasis vulgaris
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases