Psoriasis Microbiome and Phototherapy

NCT02552316

Last updated date
Study Location
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Psoriasis Microbiome and Phototherapy
Official Title  ICMJE The Cutaneous Microbiota of Psoriasis: Lesional Variation and a Phase IV, Interventional Study of Its Response to Phototherapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Psoriasis
Intervention  ICMJE Device: NB-UVB Phototherapy
Other Names:
  • Phototherapy
  • Light therapy
Study Arms  ICMJE 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.
Intervention: Device: NB-UVB Phototherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Actual Enrollment  ICMJE
 (submitted: September 16, 2015)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02552316
Other Study ID Numbers  ICMJE 821876
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Junko Takeshita, MD, PhDUniversity of Pennsylvania
PRS Account University of Pennsylvania
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP