Psoriasis Microbiome and Phototherapy

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552316
• Other study ID #: 821876
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: October 2020

Study information

• Verified date: November 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Psoriasis

Intervention

Device:
• NB-UVB Phototherapy

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Week 8
Primary	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.	Week 9
Primary	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.	Baseline
Primary	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.	Week 8
Primary	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.	Week 9
Primary	Cutaneous Bacterial Load at Baseline	Bacterial count per sample at baseline prior to initiation of phototherapy.	Baseline
Primary	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.	Week 8
Primary	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.	Week 9