PsoriasisNCT02552316

Psoriasis Microbiome and Phototherapy

A study testing NB-UVB Phototherapy in people with Psoriasis, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The ASPIRE study is a clinical trial designed to examine the microbes (e.g., bacteria) within psoriasis skin lesions compared with normal skin. The investigators will also examine the effect of NB-UVB (narrow-band ultraviolet B) phototherapy (i.e., light therapy) on skin microbes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: NB-UVB Phototherapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Oct 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females 18 years of age and older.
Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by Investigator.
Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week 1) as determined by subject interview of his/her medical history.
Subject is a candidate for phototherapy.
Subject has at least one psoriatic plaque measuring at least 6cm x 2cm located on either the arms or the legs (excluding intertriginous areas such as the axilla and inguinal folds)
Able and willing to give written informed consent and to comply with requirements of this study protocol.

Who cannot join

Subject has photosensitizing condition or other contraindication to phototherapy
Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
Cannot discontinue or avoid topical therapies for psoriasis for at least 14 days prior to the Baseline (Week 1) visit and during the study other than on face, underarms, or groin.
Cannot discontinue or avoid UVB phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 1) visit.
Subject is receiving therapy for psoriasis that requires a wash out period of more than 14 days (e.g., psoralen-UVA phototherapy, oral systemic therapy, biologic therapy, or other investigational therapy).
Other active inflammatory dermatologic conditions (e.g., eczema) or presence of pustular or erythrodermic psoriasis.

Show all 20Show fewer

Any history of acute or chronic bacterial, fungal, or viral infection (including HIV, hepatitis, tuberculosis, or other severe or recurrent infections) within 30 days of baseline sample collection.
Subject has used systemic (oral or parenteral) antibiotic, antimycotic, or antiviral within 3 months or topical antibiotic, antimycotic, or antiviral within 14 days of baseline sample collection or requires use of any topical or systemic antibiotic, antimycotic, or antiviral during the study.
Consumption of large doses of commercial probiotics (greater than or equal to 108 cfu or organisms per day) including tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, and foods do not apply.
Presence of comorbid medical condition (e.g., HIV, malignancy within past 5 years other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical carcinoma in-situ) that significantly alters the immune system or results in immunosuppression.
Subject is taking (within up to 180 days of baseline sample collection) or requires topical or systemic therapy during the study that significantly alters the immune system or results in immunosuppression (e.g., chemotherapy, oral or injectable corticosteroid). Inhaled corticosteroids for stable medical conditions are allowed.
Unstable dietary history as defined by major changes in diet within 30 days of baseline or during study, where the subject has or plans to eliminate or significantly increase major food group in the diet.
Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
History of any substance abuse within 365 days of screening visit.
Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
Major surgery of the gastrointestinal tract, with the exception of cholecystectomy and appendectomy, in the past 5 years. Any major bowel resection at any time.
History of active uncontrolled gastrointestinal disorders or diseases including:
Inflammatory bowel disease including ulcerative colitis, Crohn's disease, or indeterminate colitis;
Irritable bowel syndrome;
Persistent, infectious gastroenteritis, colitis, or gastritis, persistent or chronic diarrhea or unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: The Cutaneous Microbiota of Psoriasis: Lesional Variation and a Phase IV, Interventional Study of Its Response to Phototherapy

Conditions: Psoriasis
Being tested: NB-UVB Phototherapy
Keywords: microbiome, bacteria, NB-UVB Phototherapy, light therapy
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NB-UVB PhototherapyDevice
Also called Phototherapy, Light therapy

Study groups in NCT02552316
Study group	Role	What they receive
NB-UVB Phototherapy	Other	NB-UVB phototherapy is a therapy which uses ultraviolet B (UVB) light directed at the skin. This type of light therapy is given through the use of phototherapy booths which contain fluorescent tubes that emit UVB light. Booths used for phototherapy look similar to commercial tanning booths. NB-UVB phototherapy affects psoriasis by causing changes to the cells of the skin and producing a local effect by reducing the number of certain types of skin cells which have an impact on psoriasis formation. Receives: Device: NB-UVB Phototherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Cutaneous Microbiota Shannon's Alpha Diversity at Baseline
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline.
The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index value, the more diverse the skin microbiota. The diversity of the microbiota present in the given sample was measured using the Shannon Diversity Index, whereby each "arm title" is describing the difference in the measure of diversity between the comparison groups.
Measured: Baseline
Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 8
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. Changes in microbial diversity was assessed between baseline and week 8.
The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index value, the more diverse the skin microbiota. The diversity of the microbiota present in the given sample was measured using the Shannon Diversity Index, whereby each "arm title" is describing the difference in the measure of diversity between the comparison groups.
Measured: Week 8
Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 9.
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. Changes in microbial diversity was assessed between baseline and week 9.
The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index value, the more diverse the skin microbiota. The diversity of the microbiota present in the given sample was measured using the Shannon Diversity Index, whereby each "arm title" is describing the difference in the measure of diversity between the comparison groups.
Measured: Week 9
Cutaneous Microbiota Jaccard's Beta Diversity at Baseline
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline.
The Beta Diversity Index is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the microbiota between the two regions.
Measured: Baseline
Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 8
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. Changes in microbial diversity was assessed between baseline and week 8.
The Beta Diversity Index is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the microbiota between the two regions.
Measured: Week 8
Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 9
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. Changes in microbial diversity was assessed between baseline and week 9.
The Beta Diversity Index is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the microbiota between the two regions.
Measured: Week 9
Cutaneous Bacterial Load at Baseline
Bacterial count per sample at baseline prior to initiation of phototherapy.
Measured: Baseline
Change in Cutaneous Bacterial Load Between Baseline and Week 8.
Bacterial count per sample at baseline prior to initiation of phototherapy vs at week 8 after initiation of phototherapy.
Measured: Week 8
Change in Cutaneous Bacterial Load Between Baseline and Week 9.
Bacterial count per sample at baseline prior to initiation of phototherapy vs at week 9 after initiation of phototherapy.
Measured: Week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Oct 2020

First posted17 Sep 2015 (estimated)
Study startDec 2014
Primary completionOct 2019
Study completionOct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02552316
Sponsor's protocol ID: 821876
Status last verified: Nov 2020
First submitted: 9 Sep 2015
Last updated: 2 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis: A Prospective Randomized Controlled Study.
Psoriasis, Psoriasis Genital
Active, not recruitingObservational study
CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
Generalized Pustular Psoriasis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Cutaneous Microbiota of Psoriasis: Lesional Variation and a Phase IV, Interventional Study of Its Response to Phototherapy
ClinicalTrials.gov ID: NCT02552316
Acronym / sponsor ID: 821876
Conditions: Psoriasis
Keywords: microbiome, bacteria, NB-UVB Phototherapy, light therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Pfizer
Study start: Dec 2014 (actual)
Primary completion: Oct 2019 (actual)
Study completion: Oct 2020 (actual)
First posted: 17 Sep 2015 (estimated)
Results: Posted 2 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NB-UVB Phototherapy	Other	Device: NB-UVB PhototherapyNB-UVB phototherapy is a therapy which uses ultraviolet B (UVB) light directed at the skin. This type of light therapy is given through the use of phototherapy booths which contain fluorescent tubes that emit UVB light. Booths used for phototherapy look similar to commercial tanning booths. NB-UVB phototherapy affects psoriasis by causing changes to the cells of the skin and producing a local effect by reducing the number of certain types of skin cells which have an impact on psoriasis formation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males and females 18 years of age and older.
Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by Investigator.
Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week 1) as determined by subject interview of his/her medical history.
Subject is a candidate for phototherapy.
Subject has at least one psoriatic plaque measuring at least 6cm x 2cm located on either the arms or the legs (excluding intertriginous areas such as the axilla and inguinal folds)

Key exclusion criteria (20 listed)

Subject has photosensitizing condition or other contraindication to phototherapy
Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
Cannot discontinue or avoid topical therapies for psoriasis for at least 14 days prior to the Baseline (Week 1) visit and during the study other than on face, underarms, or groin.
Cannot discontinue or avoid UVB phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 1) visit.
Subject is receiving therapy for psoriasis that requires a wash out period of more than 14 days (e.g., psoralen-UVA phototherapy, oral systemic therapy, biologic therapy, or other investigational therapy).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NB-UVB PhototherapyAlso: Phototherapy, Light therapy	Device	NB-UVB Phototherapy

Primary outcome

Cutaneous Microbiota Shannon's Alpha Diversity at Baseline
Time frame: Baseline
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index value, the more diverse the skin microbiota. The diversity of the microbiota present in the given sample was measured using the Shannon Diversity Index, whereby each "arm title" is describing the difference in the measure of diversity between the comparison groups.
Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 8
Time frame: Week 8
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. Changes in microbial diversity was assessed between baseline and week 8. The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index value, the more diverse the skin microbiota. The diversity of the microbiota present in the given sample was measured using the Shannon Diversity Index, whereby each "arm title" is describing the difference in the measure of diversity between the comparison groups.
Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 9.
Time frame: Week 9
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. Changes in microbial diversity was assessed between baseline and week 9. The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index value, the more diverse the skin microbiota. The diversity of the microbiota present in the given sample was measured using the Shannon Diversity Index, whereby each "arm title" is describing the difference in the measure of diversity between the comparison groups.
Cutaneous Microbiota Jaccard's Beta Diversity at Baseline
Time frame: Baseline
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. The Beta Diversity Index is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the microbiota between the two regions.
Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 8
Time frame: Week 8
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. Changes in microbial diversity was assessed between baseline and week 8. The Beta Diversity Index is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the microbiota between the two regions.
Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 9
Time frame: Week 9
Variation in the microbial diversity of skin affected and unaffected by psoriasis was characterized at baseline. Changes in microbial diversity was assessed between baseline and week 9. The Beta Diversity Index is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the microbiota between the two regions.
Cutaneous Bacterial Load at Baseline
Time frame: Baseline
Bacterial count per sample at baseline prior to initiation of phototherapy.
Change in Cutaneous Bacterial Load Between Baseline and Week 8.
Time frame: Week 8
Bacterial count per sample at baseline prior to initiation of phototherapy vs at week 8 after initiation of phototherapy.
Change in Cutaneous Bacterial Load Between Baseline and Week 9.
Time frame: Week 9
Bacterial count per sample at baseline prior to initiation of phototherapy vs at week 9 after initiation of phototherapy.

Results and safety

Results posted to the registry on 2 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NB-UVB Phototherapy	34	32

Primary outcome: Cutaneous Microbiota Shannon's Alpha Diversity at Baseline

Time frame: Baseline. Mean (Standard Error). Unit: Shannon's index

Measure	Group 1a- Plaque Center vs Plaque Edge n = 15	Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected n = 24	Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin n = 26	Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant n = 29	Group 1e- Plaque Center vs Contralateral Unaffected Skin n = 10
Value	-0.05 (0.06)	0.06 (0.10)	-0.06 (0.09)	0.12 (0.08)	0.26 (0.12)

Primary outcome: Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 8

Time frame: Week 8. Mean (Standard Error). Unit: Shannon's index

Measure	Group 2a- Plaque Center n = 26	Group 2b- Ipsilateral Distant Unaffected Skin n = 25	Group 2c- Contralateral Unaffected Skin n = 12	Group 2d- Unaffected Back Skin n = 30
Value	-0.08 (0.12)	-0.12 (0.11)	0.03 (0.16)	-0.07 (0.13)

Primary outcome: Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 9.

Time frame: Week 9. Mean (Standard Error). Unit: Shannon's index

Measure	Group 3a- Plaque Center n = 26	Group 3b- Ipsilateral Distant Unaffected Skin n = 25	Group 3c- Contralateral Unaffected Skin n = 11	Group 3d- Unaffected Back Skin n = 31
Value	-0.03 (0.11)	-0.13 (0.16)	-0.01 (0.16)	0.19 (0.11)

Primary outcome: Cutaneous Microbiota Jaccard's Beta Diversity at Baseline

Time frame: Baseline. Mean (Standard Error). Unit: Jaccard index

Measure	Group 1 n = 24	Group 2 n = 27	Group 3 n = 20	Group 4 n = 27	Group 5 n = 26	Group 6 n = 27
Value	0.003 (0.015)	0.012 (0.014)	0.021 (0.015)	0.009 (0.010)	0.018 (0.011)	0.009 (0.010)

Adverse events

Time frame: 9 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NB-UVB Phototherapy	0 of 34 (0%)	17 of 34 (50%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis

RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis: A Prospective Randomized Controlled Study.
Psoriasis, Psoriasis Genital
Active, not recruitingObservational study
CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
Generalized Pustular Psoriasis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris

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.

Junko Takeshita, MD, PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NB-UVB Phototherapy in people with Psoriasis, run by University of Pennsylvania at 1 site in United States.

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 6 inclusion and 20 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 2 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cutaneous Microbiota Shannon's Alpha Diversity at Baseline (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02552316.

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 2 Dec 2020; AzTrials last refreshed its copy on 26 Oct 2026.