Psoriasis
Conditions
Keywords
microbiome, bacteria, NB-UVB Phototherapy, light therapy
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.
Interventions
DEVICENB-UVB Phototherapy
Sponsors
Pfizer
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cutaneous Microbiota Shannon's Alpha Diversity at Baseline | 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 | 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. | 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 | 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 | 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 | 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 | Baseline | Bacterial count per sample at baseline prior to initiation of phototherapy. |
| Change in Cutaneous Bacterial Load Between Baseline and Week 8. | 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. | Week 9 | Bacterial count per sample at baseline prior to initiation of phototherapy vs at week 9 after initiation of phototherapy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
NB-UVB Phototherapy | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
| Overall Study | Withdrawal due to non-compliance | 1 |
Baseline characteristics
| Characteristic | NB-UVB Phototherapy |
|---|---|
| Age, Continuous | 45.5 years |
| Age of psoriasis onset 20 - 39 years | 10 Participants |
| Age of psoriasis onset < 20 years | 16 Participants |
| Age of psoriasis onset ≥40 years | 8 Participants |
| Body Mass Index | 29.60 Kg/m^2 |
| Body Surface Area (BSA) | 7.55 percentage (%) |
| Duration of psoriasis (year) | 11.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick skin type Type I | 1 Participants |
| Fitzpatrick skin type Type II | 18 Participants |
| Fitzpatrick skin type Type III | 6 Participants |
| Fitzpatrick skin type Type IV | 4 Participants |
| Fitzpatrick skin type Type V | 5 Participants |
| Physician Global Assessment (PGA) Lesion | 3 units on a scale |
| Physician Global Assessment (PGA) Overall | 3 units on a scale |
| Plaque location Arm | 8 Participants |
| Plaque location Leg | 26 Participants |
| Psoriasis Area and Severity Index (PASI) score | 9.55 units on a scale |
| Psoriatic arthritis diagnosis No | 33 Participants |
| Psoriatic arthritis diagnosis Yes | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 17 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1a- Plaque Center vs Plaque Edge | Change in Cutaneous Bacterial Load Between Baseline and Week 8. | 0.53 Log10 [bacterial count/sample] | Standard Error 0.2 |
| Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | Change in Cutaneous Bacterial Load Between Baseline and Week 8. | 0.85 Log10 [bacterial count/sample] | Standard Error 0.41 |
| Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | Change in Cutaneous Bacterial Load Between Baseline and Week 8. | -0.05 Log10 [bacterial count/sample] | Standard Error 0.23 |
| Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | Change in Cutaneous Bacterial Load Between Baseline and Week 8. | -0.08 Log10 [bacterial count/sample] | Standard Error 0.16 |
| Group 1e- Plaque Center vs Contralateral Unaffected Skin | Change in Cutaneous Bacterial Load Between Baseline and Week 8. | -0.01 Log10 [bacterial count/sample] | Standard Error 0.2 |
| Group 6 | Change in Cutaneous Bacterial Load Between Baseline and Week 8. | -0.01 Log10 [bacterial count/sample] | Standard Error 0.18 |
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.
Time frame: Week 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1a- Plaque Center vs Plaque Edge | Change in Cutaneous Bacterial Load Between Baseline and Week 9. | 0.68 Log10 [bacterial count/sample] | Standard Error 0.17 |
| Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | Change in Cutaneous Bacterial Load Between Baseline and Week 9. | 0.61 Log10 [bacterial count/sample] | Standard Error 0.42 |
| Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | Change in Cutaneous Bacterial Load Between Baseline and Week 9. | -0.01 Log10 [bacterial count/sample] | Standard Error 0.17 |
| Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | Change in Cutaneous Bacterial Load Between Baseline and Week 9. | -0.01 Log10 [bacterial count/sample] | Standard Error 0.15 |
| Group 1e- Plaque Center vs Contralateral Unaffected Skin | Change in Cutaneous Bacterial Load Between Baseline and Week 9. | -0.02 Log10 [bacterial count/sample] | Standard Error 0.24 |
| Group 6 | Change in Cutaneous Bacterial Load Between Baseline and Week 9. | -0.002 Log10 [bacterial count/sample] | Standard Error 0.18 |
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1a- Plaque Center vs Plaque Edge | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 8 | -0.021 Jaccard's index | Standard Error 0.02 |
| Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 8 | -0.002 Jaccard's index | Standard Error 0.016 |
| Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 8 | 0.008 Jaccard's index | Standard Error 0.009 |
| Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 8 | 0.013 Jaccard's index | Standard Error 0.011 |
| Group 1e- Plaque Center vs Contralateral Unaffected Skin | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 8 | 0.008 Jaccard's index | Standard Error 0.01 |
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.
Time frame: Week 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1a- Plaque Center vs Plaque Edge | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 9 | -0.016 Jaccard's index | Standard Error 0.019 |
| Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 9 | -0.001 Jaccard's index | Standard Error 0.01 |
| Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 9 | -0.007 Jaccard's index | Standard Error 0.009 |
| Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 9 | -0.004 Jaccard's index | Standard Error 0.011 |
| Group 1e- Plaque Center vs Contralateral Unaffected Skin | Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 9 | 0.0002 Jaccard's index | Standard Error 0.011 |
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1a- Plaque Center vs Plaque Edge | Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 8 | -0.08 Shannon's index | Standard Error 0.12 |
| Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 8 | -0.12 Shannon's index | Standard Error 0.11 |
| Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 8 | 0.03 Shannon's index | Standard Error 0.16 |
| Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 8 | -0.07 Shannon's index | Standard Error 0.13 |
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.
Time frame: Week 9
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1a- Plaque Center vs Plaque Edge | Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 9. | -0.03 Shannon's index | Standard Error 0.11 |
| Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 9. | -0.13 Shannon's index | Standard Error 0.16 |
| Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 9. | -0.01 Shannon's index | Standard Error 0.16 |
| Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 9. | 0.19 Shannon's index | Standard Error 0.11 |
Primary
Cutaneous Bacterial Load at Baseline
Bacterial count per sample at baseline prior to initiation of phototherapy.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1a- Plaque Center vs Plaque Edge | Cutaneous Bacterial Load at Baseline | 0.21 Log10 [bacterial count/sample] | Standard Error 0.24 |
| Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | Cutaneous Bacterial Load at Baseline | 0.60 Log10 [bacterial count/sample] | Standard Error 0.18 |
| Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | Cutaneous Bacterial Load at Baseline | 0.71 Log10 [bacterial count/sample] | Standard Error 0.17 |
| Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | Cutaneous Bacterial Load at Baseline | 0.57 Log10 [bacterial count/sample] | Standard Error 0.21 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1a- Plaque Center vs Plaque Edge | Cutaneous Microbiota Jaccard's Beta Diversity at Baseline | 0.003 Jaccard index | Standard Error 0.015 |
| Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | Cutaneous Microbiota Jaccard's Beta Diversity at Baseline | 0.012 Jaccard index | Standard Error 0.014 |
| Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | Cutaneous Microbiota Jaccard's Beta Diversity at Baseline | 0.021 Jaccard index | Standard Error 0.015 |
| Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | Cutaneous Microbiota Jaccard's Beta Diversity at Baseline | 0.009 Jaccard index | Standard Error 0.01 |
| Group 1e- Plaque Center vs Contralateral Unaffected Skin | Cutaneous Microbiota Jaccard's Beta Diversity at Baseline | 0.018 Jaccard index | Standard Error 0.011 |
| Group 6 | Cutaneous Microbiota Jaccard's Beta Diversity at Baseline | 0.009 Jaccard index | Standard Error 0.01 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1a- Plaque Center vs Plaque Edge | Cutaneous Microbiota Shannon's Alpha Diversity at Baseline | -0.05 Shannon's index | Standard Error 0.06 |
| Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | Cutaneous Microbiota Shannon's Alpha Diversity at Baseline | 0.06 Shannon's index | Standard Error 0.1 |
| Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | Cutaneous Microbiota Shannon's Alpha Diversity at Baseline | -0.06 Shannon's index | Standard Error 0.09 |
| Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | Cutaneous Microbiota Shannon's Alpha Diversity at Baseline | 0.12 Shannon's index | Standard Error 0.08 |
| Group 1e- Plaque Center vs Contralateral Unaffected Skin | Cutaneous Microbiota Shannon's Alpha Diversity at Baseline | 0.26 Shannon's index | Standard Error 0.12 |