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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NB-UVB Phototherapy | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NB-UVB Phototherapy | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Subject has photosensitizing condition or other contraindication to phototherapy
Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
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.
Cannot discontinue or avoid UVB phototherapy or Excimer laser for at least 14 days prior to the Baseline (Week 1) visit.
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).
Other active inflammatory dermatologic conditions (e.g., eczema) or presence of pustular or erythrodermic psoriasis.
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.
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.
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.
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.
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.
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.
Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
History of any substance abuse within 365 days of screening visit.
Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
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.
History of active uncontrolled gastrointestinal disorders or diseases including:
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| Name | Affiliation | Role |
|---|---|---|
| Junko Takeshita, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NB-UVB Phototherapy | Narrow band-UVB (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. In the study, NB-UVB phototherapy administered 3 times per week for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | Shannon's index | Baseline |
|
9 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Junko Takeshita | University of Pennsylvania | 215-349-5551 | Junko.Takeshita@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2020 | Nov 3, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 23, 2015 | Nov 4, 2020 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2016 | Nov 4, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Baseline |
| 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 |
| 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 |
| Cutaneous Bacterial Load at Baseline | Bacterial count per sample at baseline prior to initiation of phototherapy. | Baseline |
| 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 |
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Median | Inter-Quartile Range | Kg/m^2 |
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| Fitzpatrick skin type | Fitzpatrick skin type describes a method of classifying skin by its reaction to sunlight. This system classifies skin types from I through V whereby a lower Fitzpatrick skin type classification indicates skin that burns more easily than it tans, while a higher Fitzpatrick skin type indicates the opposite. The skin type classification criteria are detailed below. Type I: Always burns, never tans Type II: Burns easily, tans poorly Type III: Tans after initial burn Type IV: Rarely burns and tans darkly easily Type V: Never burns, always tans very darkly | Count of Participants | Participants |
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| Age of psoriasis onset | Count of Participants | Participants |
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| Duration of psoriasis (year) | Median | Inter-Quartile Range | years |
|
| Psoriasis Area and Severity Index (PASI) score | The Psoriasis Area Severity Index (PASI) is an instrument that measures the severity and extent of psoriasis. The score is based on a combination of psoriasis appearance (erythema, induration and desquamation) and percentage of body surface area. The scale ranges from 0 (no disease) to 72 (maximal disease severity), whereby higher PASI scores indicate higher severity of psoriasis. | Median | Inter-Quartile Range | units on a scale |
|
| Physician Global Assessment (PGA) | This PGA scale is an assessment of severity whereby physician's rating of erythema, induration and scaling is assessed, individually, on a five-point scale (from 0 = no symptom to 4 = severe). The total score is the mean of the three item scores, each having an equal weighting, with the total scores ranging between 0 (clear skin) and 4 (severe disease) and higher score indicating more severe psoriasis. | Median | Inter-Quartile Range | units on a scale |
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| Body Surface Area (BSA) | Median | Inter-Quartile Range | percentage (%) |
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| Psoriatic arthritis diagnosis | Count of Participants | Participants |
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| Plaque location | Count of Participants | Participants |
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| OG001 | Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected | The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy. Difference in the measure of Shannon diversity index between plaque center vs ipsilateral perilesional unaffected skin |
| OG002 | Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin | The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy. Difference in the measure of Shannon diversity index between plaque center vs ipsilateral distant unaffected skin. |
| OG003 | Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant | The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy. Difference in the measure of Shannon diversity index between perilesional ipsilateral unaffected skin vs distant ipsilateral unaffected skin. |
| OG004 | Group 1e- Plaque Center vs Contralateral Unaffected Skin | The diversity of microbiota present in a given sample measured using the Shannon Diversity Index at baseline prior to initiation of phototherapy. Difference in the measure of Shannon diversity index between plaque center vs contralateral unaffected skin. |
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| 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. | Posted | Mean | Standard Error | Shannon's index | Week 8 |
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| 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. | Posted | Mean | Standard Error | Shannon's index | Week 9 |
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| 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. | Posted | Mean | Standard Error | Jaccard index | Baseline |
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| 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. | Posted | Mean | Standard Error | Jaccard's index | Week 8 |
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| 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. | Posted | Mean | Standard Error | Jaccard's index | Week 9 |
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| Primary | Cutaneous Bacterial Load at Baseline | Bacterial count per sample at baseline prior to initiation of phototherapy. | Posted | Mean | Standard Error | Log10 [bacterial count/sample] | Baseline |
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| 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. | Posted | Mean | Standard Error | Log10 [bacterial count/sample] | Week 8 |
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| 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. | Posted | Mean | Standard Error | Log10 [bacterial count/sample] | Week 9 |
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| 0 |
| 34 |
| 0 |
| 34 |
| 17 |
| 34 |
| Tenderness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Burn | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pruiritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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