Trial Outcomes & Findings for Psoriasis Microbiome and Phototherapy (NCT NCT02552316)
NCT ID: NCT02552316
Last Updated: 2020-12-02
Results Overview
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.
COMPLETED
NA
34 participants
Baseline
2020-12-02
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Withdrawal due to non-compliance
|
1
|
Baseline Characteristics
Psoriasis Microbiome and Phototherapy
Baseline characteristics by cohort
| Measure |
NB-UVB Phototherapy
n=34 Participants
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
|
|---|---|
|
Age, Continuous
|
45.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Body Mass Index
|
29.60 Kg/m^2
n=5 Participants
|
|
Fitzpatrick skin type
Type I
|
1 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type II
|
18 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type III
|
6 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type IV
|
4 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type V
|
5 Participants
n=5 Participants
|
|
Age of psoriasis onset
< 20 years
|
16 Participants
n=5 Participants
|
|
Age of psoriasis onset
20 - 39 years
|
10 Participants
n=5 Participants
|
|
Age of psoriasis onset
≥40 years
|
8 Participants
n=5 Participants
|
|
Duration of psoriasis (year)
|
11.5 years
n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) score
|
9.55 units on a scale
n=5 Participants
|
|
Physician Global Assessment (PGA)
Overall
|
3 units on a scale
n=5 Participants
|
|
Physician Global Assessment (PGA)
Lesion
|
3 units on a scale
n=5 Participants
|
|
Body Surface Area (BSA)
|
7.55 percentage (%)
n=5 Participants
|
|
Psoriatic arthritis diagnosis
No
|
33 Participants
n=5 Participants
|
|
Psoriatic arthritis diagnosis
Yes
|
1 Participants
n=5 Participants
|
|
Plaque location
Arm
|
8 Participants
n=5 Participants
|
|
Plaque location
Leg
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineVariation 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.
Outcome measures
| Measure |
Group 1a- Plaque Center vs Plaque Edge
n=15 Participants
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 plaque edge.
|
Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected
n=24 Participants
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
|
Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin
n=26 Participants
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.
|
Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant
n=29 Participants
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.
|
Group 1e- Plaque Center vs Contralateral Unaffected Skin
n=10 Participants
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.
|
Group 6
The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.
Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline.
|
|---|---|---|---|---|---|---|
|
Cutaneous Microbiota Shannon's Alpha Diversity at Baseline
|
-0.05 Shannon's index
Standard Error 0.06
|
0.06 Shannon's index
Standard Error 0.10
|
-0.06 Shannon's index
Standard Error 0.09
|
0.12 Shannon's index
Standard Error 0.08
|
0.26 Shannon's index
Standard Error 0.12
|
—
|
PRIMARY outcome
Timeframe: Week 8Variation 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.
Outcome measures
| Measure |
Group 1a- Plaque Center vs Plaque Edge
n=26 Participants
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 plaque edge.
|
Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected
n=25 Participants
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
|
Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin
n=12 Participants
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.
|
Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant
n=30 Participants
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.
|
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.
|
Group 6
The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.
Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline.
|
|---|---|---|---|---|---|---|
|
Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 8
|
-0.08 Shannon's index
Standard Error 0.12
|
-0.12 Shannon's index
Standard Error 0.11
|
0.03 Shannon's index
Standard Error 0.16
|
-0.07 Shannon's index
Standard Error 0.13
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 9Variation 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.
Outcome measures
| Measure |
Group 1a- Plaque Center vs Plaque Edge
n=26 Participants
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 plaque edge.
|
Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected
n=25 Participants
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
|
Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin
n=11 Participants
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.
|
Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant
n=31 Participants
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.
|
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.
|
Group 6
The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.
Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline.
|
|---|---|---|---|---|---|---|
|
Change in Cutaneous Microbiota Shannon's Alpha Diversity at Baseline vs Week 9.
|
-0.03 Shannon's index
Standard Error 0.11
|
-0.13 Shannon's index
Standard Error 0.16
|
-0.01 Shannon's index
Standard Error 0.16
|
0.19 Shannon's index
Standard Error 0.11
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineVariation 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.
Outcome measures
| Measure |
Group 1a- Plaque Center vs Plaque Edge
n=24 Participants
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 plaque edge.
|
Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected
n=27 Participants
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
|
Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin
n=20 Participants
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.
|
Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant
n=27 Participants
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.
|
Group 1e- Plaque Center vs Contralateral Unaffected Skin
n=26 Participants
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.
|
Group 6
n=27 Participants
The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.
Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline.
|
|---|---|---|---|---|---|---|
|
Cutaneous Microbiota Jaccard's Beta Diversity at Baseline
|
0.003 Jaccard index
Standard Error 0.015
|
0.012 Jaccard index
Standard Error 0.014
|
0.021 Jaccard index
Standard Error 0.015
|
0.009 Jaccard index
Standard Error 0.010
|
0.018 Jaccard index
Standard Error 0.011
|
0.009 Jaccard index
Standard Error 0.010
|
PRIMARY outcome
Timeframe: Week 8Variation 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.
Outcome measures
| Measure |
Group 1a- Plaque Center vs Plaque Edge
n=15 Participants
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 plaque edge.
|
Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected
n=29 Participants
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
|
Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin
n=29 Participants
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.
|
Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant
n=15 Participants
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.
|
Group 1e- Plaque Center vs Contralateral Unaffected Skin
n=32 Participants
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.
|
Group 6
The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.
Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline.
|
|---|---|---|---|---|---|---|
|
Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 8
|
-0.021 Jaccard's index
Standard Error 0.020
|
-0.002 Jaccard's index
Standard Error 0.016
|
0.008 Jaccard's index
Standard Error 0.009
|
0.013 Jaccard's index
Standard Error 0.011
|
0.008 Jaccard's index
Standard Error 0.010
|
—
|
PRIMARY outcome
Timeframe: Week 9Variation 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.
Outcome measures
| Measure |
Group 1a- Plaque Center vs Plaque Edge
n=15 Participants
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 plaque edge.
|
Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected
n=28 Participants
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
|
Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin
n=29 Participants
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.
|
Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant
n=15 Participants
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.
|
Group 1e- Plaque Center vs Contralateral Unaffected Skin
n=32 Participants
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.
|
Group 6
The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.
Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline.
|
|---|---|---|---|---|---|---|
|
Change in Cutaneous Microbiota Jaccard's Beta Diversity at Baseline vs Week 9
|
-0.016 Jaccard's index
Standard Error 0.019
|
-0.001 Jaccard's index
Standard Error 0.010
|
-0.007 Jaccard's index
Standard Error 0.009
|
-0.004 Jaccard's index
Standard Error 0.011
|
0.0002 Jaccard's index
Standard Error 0.011
|
—
|
PRIMARY outcome
Timeframe: BaselineBacterial count per sample at baseline prior to initiation of phototherapy.
Outcome measures
| Measure |
Group 1a- Plaque Center vs Plaque Edge
n=34 Participants
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 plaque edge.
|
Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected
n=34 Participants
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
|
Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin
n=34 Participants
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.
|
Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant
n=34 Participants
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.
|
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.
|
Group 6
The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.
Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline.
|
|---|---|---|---|---|---|---|
|
Cutaneous Bacterial Load at Baseline
|
0.21 Log10 [bacterial count/sample]
Standard Error 0.24
|
0.60 Log10 [bacterial count/sample]
Standard Error 0.18
|
0.71 Log10 [bacterial count/sample]
Standard Error 0.17
|
0.57 Log10 [bacterial count/sample]
Standard Error 0.21
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 8Bacterial count per sample at baseline prior to initiation of phototherapy vs at week 8 after initiation of phototherapy.
Outcome measures
| Measure |
Group 1a- Plaque Center vs Plaque Edge
n=34 Participants
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 plaque edge.
|
Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected
n=18 Participants
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
|
Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin
n=31 Participants
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.
|
Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant
n=32 Participants
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.
|
Group 1e- Plaque Center vs Contralateral Unaffected Skin
n=16 Participants
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.
|
Group 6
n=33 Participants
The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.
Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline.
|
|---|---|---|---|---|---|---|
|
Change in Cutaneous Bacterial Load Between Baseline and Week 8.
|
0.53 Log10 [bacterial count/sample]
Standard Error 0.20
|
0.85 Log10 [bacterial count/sample]
Standard Error 0.41
|
-0.05 Log10 [bacterial count/sample]
Standard Error 0.23
|
-0.08 Log10 [bacterial count/sample]
Standard Error 0.16
|
-0.01 Log10 [bacterial count/sample]
Standard Error 0.20
|
-0.01 Log10 [bacterial count/sample]
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Week 9Bacterial count per sample at baseline prior to initiation of phototherapy vs at week 9 after initiation of phototherapy.
Outcome measures
| Measure |
Group 1a- Plaque Center vs Plaque Edge
n=34 Participants
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 plaque edge.
|
Group 1b- Plaque Center vs Ipsilateral Perilesional Unaffected
n=18 Participants
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
|
Group 1c- Plaque Center vs Ipsilateral Distant Unaffected Skin
n=31 Participants
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.
|
Group 1d- Ipsilateral Unaffected Skin: Perilesional vs Distant
n=32 Participants
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.
|
Group 1e- Plaque Center vs Contralateral Unaffected Skin
n=16 Participants
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.
|
Group 6
n=33 Participants
The diversity of microbiota present in a given sample measured using the Jaccard's Diversity Index at baseline prior to initiation of phototherapy.
Comparison of differences in mean between Ipsilateral distant unaffected skin vs plaque center and contralateral unaffected skin vs plaque center at baseline.
|
|---|---|---|---|---|---|---|
|
Change in Cutaneous Bacterial Load Between Baseline and Week 9.
|
0.68 Log10 [bacterial count/sample]
Standard Error 0.17
|
0.61 Log10 [bacterial count/sample]
Standard Error 0.42
|
-0.01 Log10 [bacterial count/sample]
Standard Error 0.17
|
-0.01 Log10 [bacterial count/sample]
Standard Error 0.15
|
-0.02 Log10 [bacterial count/sample]
Standard Error 0.24
|
-0.002 Log10 [bacterial count/sample]
Standard Error 0.18
|
Adverse Events
NB-UVB Phototherapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NB-UVB Phototherapy
n=34 participants at risk
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
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
41.2%
14/34 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Tenderness
|
35.3%
12/34 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Burn
|
8.8%
3/34 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Pruiritis
|
5.9%
2/34 • 9 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place