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Psoriasis Microbiome and Phototherapy

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ClinicalTrials.gov Identifier: NCT02552316
Recruitment Status : Completed
First Posted : September 17, 2015
Results First Posted : December 2, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Device: NB-UVB Phototherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Cutaneous Microbiota of Psoriasis: Lesional Variation and a Phase IV, Interventional Study of Its Response to Phototherapy
Actual Study Start Date : December 2014
Actual Primary Completion Date : October 2019
Actual Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
NB-UVB Phototherapy
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.
Device: NB-UVB Phototherapy
Other Names:
  • Phototherapy
  • Light therapy




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. Cutaneous Bacterial Load at Baseline [ Time Frame: Baseline ]
    Bacterial count per sample at baseline prior to initiation of phototherapy.

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  11. 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.
  12. 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.
  13. Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
  14. History of any substance abuse within 365 days of screening visit.
  15. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
  16. 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.
  17. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552316


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Pfizer
Investigators
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Principal Investigator: Junko Takeshita, MD, PhD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Statistical Analysis Plan  [PDF] September 23, 2020
Study Protocol  [PDF] September 23, 2015
Informed Consent Form  [PDF] March 24, 2016

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02552316    
Other Study ID Numbers: 821876
First Posted: September 17, 2015    Key Record Dates
Results First Posted: December 2, 2020
Last Update Posted: December 2, 2020
Last Verified: November 2020
Keywords provided by University of Pennsylvania:
microbiome
bacteria
NB-UVB Phototherapy
light therapy
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases