PsoriasisMICROBIOTANCT03475914
Characterization of Cutaneous Microbiota in the Psoriasis Pathogenesis
An observational study of Psoriasis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2016to 21 Nov 2017
- How long will I take part?
- 8 Months
- 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 years and older
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- over 18 years of age;
- use of a free-preservatives soap with moisturizing function, applied once a day;pets.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis
- Keywords
- Psoriasis Guttate, Psoriasis vulgaris
- Medical subject headings
- Psoriasis, Guttate Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Psoriasis Area and Severity Index (PASI)
It is a measurement of psoriasis severity .
Measured: 1 year
Secondary outcomes (5)
Chao's index
It is a measure of bacterial biodiversity
Measured: 1 year
Microbial abundance
It is a measure of bacterial amount
Measured: 1 year
Spearman's correlation
It a measure of the bacterial interactions
Measured: 1 year
Shannon's index
It is a measure of bacterial biodiversity
Measured: At the beginning of the study
Simpson's index
It is a measure of bacterial biodiversity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start13 Oct 2016
- Primary completion29 Jun 2017
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475914
- Sponsor's protocol ID
- MICROBIOTA
- Acronym
- MICROBIOTA
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Cutaneous Microbiota and Evaluation of the Antimicrobial Peptides Roles in the Psoriasis Etiopathogenesis
- ClinicalTrials.gov ID
- NCT03475914
- Acronym / sponsor ID
- MICROBIOTA / MICROBIOTA
- Conditions
- Psoriasis
- Keywords
- Psoriasis Guttate, Psoriasis vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 23 Mar 2018 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 8 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- over 18 years of age;
- use of a free-preservatives soap with moisturizing function, applied once a day;pets.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the Psoriasis Area and Severity Index (PASI)
Time frame: 1 year
It is a measurement of psoriasis severity .
5 secondary outcomes
Chao's index
Time frame: 1 year
Microbial abundance
Time frame: 1 year
Spearman's correlation
Time frame: 1 year
Shannon's index
Time frame: At the beginning of the study
Simpson's index
Time frame: 1 year
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 23 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
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 2 inclusion and 8 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluation of the Psoriasis Area and Severity Index (PASI) (time frame: 1 year). 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 23 Mar 2018.