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Psoriasis Microbiome and Phototherapy | Clinical Trials | Clareo Health

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Psoriasis Microbiome and Phototherapy

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

NCT02552316•University of Pennsylvania

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females 18 years of age and older.
•2. 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.
•3. 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.
•4. Subject is a candidate for phototherapy.
•5. 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)
•6. Able and willing to give written informed consent and to comply with requirements of this study protocol.

Exclusion Criteria

•1. Subject has photosensitizing condition or other contraindication to phototherapy
•2. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
•3. 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.
•4. Cannot discontinue or avoid UVB phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 1) visit.
•5. 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).
•6. Other active inflammatory dermatologic conditions (e.g., eczema) or presence of pustular or erythrodermic psoriasis.
•7. 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.
•8. 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.
•9. 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.
•10. 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.
+10 more criteria

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 1, 2014

Primary Completion Date

October 1, 2019

Completion Date

October 1, 2020

Last Updated

December 2, 2020

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

NB-UVB Phototherapy

DEVICE

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Psoriasis Microbiome and Phototherapy

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments