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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

Baseline

Results posted on

2020-12-02

Participant Flow

Participant milestones

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.
Overall Study
STARTED
34
Overall Study
COMPLETED
32
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

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.
Overall Study
Withdrawal by Subject
1
Overall Study
Withdrawal due to non-compliance
1

Baseline Characteristics

Psoriasis Microbiome and Phototherapy

Baseline characteristics by cohort

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: 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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: 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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: Baseline

Bacterial count per sample at baseline prior to initiation of phototherapy.

Outcome measures

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 8

Bacterial count per sample at baseline prior to initiation of phototherapy vs at week 8 after initiation of phototherapy.

Outcome measures

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 9

Bacterial count per sample at baseline prior to initiation of phototherapy vs at week 9 after initiation of phototherapy.

Outcome measures

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 events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Junko Takeshita

University of Pennsylvania

Phone: 215-349-5551

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place