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CompletedNCT03726489LITEUpdated Sep 19, 2024Results posted

Light Treatment Effectiveness (LITE) Study

An interventional study of Daavlin 7 series 3 panel narrow band phototherapy home units and narrow band phototherapy clinic units in Psoriasis and Psoriatic Plaque, sponsored by University of Pennsylvania. Completed at 38 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
783
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis

Read the detailed description

The primary objective of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis. Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. This is a three year pragmatic, randomized, active comparator effectiveness study.

02

Conditions studied

  • Psoriasis
  • Psoriatic Plaque

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 783 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
  2. Age 12 or older
  3. Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of >1.0, and considered a candidate for phototherapy

  4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy:

    1. In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
    2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
  5. New or established patient in the practice

Exclusion criteria

Exclusion Criteria:

  1. Patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints

  2. Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:

    1. How to operate the phototherapy device
    2. How to follow the dosing protocol
    3. Requirement to wear protective eyewear and genital protection equipment
  3. Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
  4. Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0

  5. Patients deemed unsafe to be treated with phototherapy:

    1. History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
    2. History of arsenic intake
    3. Unable to tolerate standing for required duration of treatment due to age or physical function
    4. History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
  6. Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
783 participants (actual)

Study arms

  • Other
    Office Based Phototherapy

    Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.

    Device: narrow band phototherapy clinic units

  • Active comparator
    Home Based Phototherapy

    Patients randomized to this arm will receive narrow band phototherapy in a home setting via Daavlin 7 series 3 panel narrow band phototherapy home units.

    Device: Daavlin 7 series 3 panel narrow band phototherapy home units

Interventions

  • DeviceDaavlin 7 series 3 panel narrow band phototherapy home units

    Daavlin 7 series 3 panel narrow band phototherapy home units (with 8-12 bulbs and a smaller, flat surface with door, measuring 21" wide, 74.5" tall, and 23.5"). This unit is a class II device with a FDA 510K indication for psoriasis, vitiligo and atopic dermatitis/eczema. The unit will have a dosimetry controller, a UV sensor built in that measures the intensity of the light. This sensor will adjust the treatment time to compensate for any variation in output due to aging of the lamps or other factors

  • Devicenarrow band phototherapy clinic units

    Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure

06

What researchers measure

Primary outcomes

  1. Physician Global Assessment (PGA) Score of Clear/Almost Clear

    Measure of clinical treatment response, with PGA score of 0/1 (clear/almost clear). PGA score range from 0 (clear) to 5 (worst disease state).

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  2. Impact of Dermatological Disease on Quality of Life (DLQI ≤5)

    Dermatology Life Quality Index (DLQI) score of ≤5 which corresponds to no to small impact of dermatologic disease on quality of life. DLQI is a 10 item survey that asks patients questions about their health related quality of life on a 0-3 scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

Secondary outcomes

  1. Total Number of Phototherapy Treatments Received

    patient or site reported phototherapy dosing

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  2. Cumulative Dose of Phototherapy Received

    Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit.

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  3. Concomitant Topical Psoriasis Treatment

    Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication

    Time frame: week 12 and week 24 after randomization

  4. Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments

    Time frame: week 12 and week 24 after randomization

  5. Patient-reported Time Spent on Phototherapy Per Treatment

    patient reported survey

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  6. Patient Reported Costs Associated With Travel for Phototherapy Treatments

    patient reported survey for Office patients only

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  7. Patient Reported Time Associated With Travel for Phototherapy Treatments

    patient reported survey for Office patients only

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  8. DLQI (0-1)

    Dermatology Life Quality Index (DLQI) score of ≤1 which corresponds to no impact of dermatologic disease on quality of life. DLQI is a 10 item survey that asks patients questions about their health related quality of life on a 0-3 scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  9. Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI

    A difference of 4 was determined to be the MCID

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  10. Physician Global Assessment Times Body Surface Area (PGAxBSA)

    The difference in PGAxBSA from baseline to week 12. Values range from -500 to 500, with negative values indicating improvement in disease. BSA is a measure of the body surface area affected by psoriasis using the handprint method in which the palm of the entire hand approximates 1% of the body surface area. PGA is previously described. The product of the two measurements (PGA×BSA) has been investigated to assess psoriasis severity, with higher values indicating greater disease burden. Reference: Chiesa Fuxench et al. Validity of the simple-measure for assessing psoriasis activity (S-MAPA) for objectively evaluating disease severity in patients with plaque psoriasis. J Am Acad Dermatol 2015;73:868-7.

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  11. PGA x BSA 75%

    Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  12. PGA x BSA 90%

    Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  13. Duration of Treatment Response During Observation Period

    Defined as the length of time from week 12 to the earliest of DLQI \> 5 or time of initiation of a new systemic treatment or dose escalation of an existing systemic treatment, with patients who maintain DLQI \<=5 5 throughout the 12 week observation period with no new systemic treatments or dose escalation censored at week 24.

    Time frame: 24 weeks after randomization

  14. Patients Receiving at Least 80% of Treatments

    80% of assigned treatments is defined as 24 total treatments. Patients must have at least one treatment to be included.

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

Other outcomes

  1. Safety Analysis of Skin Related Events

    Burns lasting 48 hours or more

    Time frame: Week 12

  2. Physician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)

    The outcome measure is previously described. This analysis repeats the primary outcome of PGA clear/almost clear among patients who received at least 24 treatments (i.e. 80% of assigned treatments).

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  3. Impact of Dermatological Disease on Quality of Life ("As Treated" Analysis)

    The outcome measure is previously described. This analysis repeats the primary outcome of DLQI \<=5 among patients who received at least 24 treatments (i.e. 80% of assigned treatments).

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

  4. Dichotomized DLQI Beyond Week 12

    Number of participants that had a DLQI \<= 5 at week 16, week 20, and week 24

    Time frame: From Week 12 to Week 24

07

Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneOffice Based PhototherapyHome Based Phototherapy
Started390393
Received phototherapy232309
Dlqi assessed252308
Pga assessed217255
Completed390393
Not completed00

Outcome measures

PrimaryPhysician Global Assessment (PGA) Score of Clear/Almost Clear

Measure of clinical treatment response, with PGA score of 0/1 (clear/almost clear). PGA score range from 0 (clear) to 5 (worst disease state).

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Count of participants · Participants
Physician Global Assessment (PGA) Score of Clear/Almost Clear
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes100129
Phototype I/II4758
Phototype III/IV4757
Phototype V/VI614
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.001 (P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.) · Risk difference (rd): 7.2 · 95% CI 0.8 to 13.5Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.001 (P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.) · Risk difference (rd): 4.2 · 95% CI -5.4 to 13.8Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.001 (P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.) · Risk difference (rd): 7.4 · 95% CI -2.2 to 17.0Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.001 (P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.) · Risk difference (rd): 18.7 · 95% CI 0.8 to 36.6Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Logistic · p = 0.347 (HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.)We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.
PrimaryImpact of Dermatological Disease on Quality of Life (DLQI ≤5)

Dermatology Life Quality Index (DLQI) score of ≤5 which corresponds to no to small impact of dermatologic disease on quality of life. DLQI is a 10 item survey that asks patients questions about their health related quality of life on a 0-3 scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Count of participants · Participants
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes131206
Phototype I/II65108
Phototype III/IV5681
Phototype V/VI1017
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.001 (P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.) · Risk difference (rd): 18.6 · 95% CI 11.8 to 25.3Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.001 (P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.) · Risk difference (rd): 21.2 · 95% CI 11.0 to 31.5Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.001 (P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.) · Risk difference (rd): 16.5 · 95% CI 6.4 to 26.6Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.001 (P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.) · Risk difference (rd): 16.1 · 95% CI -3.7 to 35.9Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Logistic · p = 0.873 (HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.)We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.
SecondaryTotal Number of Phototherapy Treatments Received

patient or site reported phototherapy dosing

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Mean · treatments
Total Number of Phototherapy Treatments Received
treatmentsOffice Based PhototherapyHome Based Phototherapy
All phototypes17.95 ± 8.8326.82 ± 10.63
Phototype I/II18.86 ± 8.9928.24 ± 9.57
Phototype III/IV17.72 ± 8.4926.20 ± 11.40
Phototype V/VI14.96 ± 9.1521.78 ± 11.07
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 8.7 · 95% CI 7.1 to 10.4Adjusted for skin phototype
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 9.38 · 95% CI 7.05 to 11.71
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 8.48 · 95% CI 5.82 to 11.14
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.0213 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 6.82 · 95% CI 1.06 to 12.58
SecondaryCumulative Dose of Phototherapy Received

Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit.

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Mean · J/cm^2
Cumulative Dose of Phototherapy Received
J/cm^2Office Based PhototherapyHome Based Phototherapy
All phototypes17.27 ± 16.0931.43 ± 29.55
Phototype I/II15.04 ± 13.1926.51 ± 20.94
Phototype III/IV18.93 ± 16.7932.80 ± 27.64
Phototype V/VI19.90 ± 22.8652.73 ± 58.29
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 14.6 · 95% CI 10.4 to 18.7Adjusted for skin phototype
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 11.47 · 95% CI 6.93 to 16.01
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 13.87 · 95% CI 7.77 to 19.98
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.0127 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 32.84 · 95% CI 7.32 to 58.35
SecondaryConcomitant Topical Psoriasis Treatment

Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication

Time frame:
week 12 and week 24 after randomization
Reported as:
Mean · days per week
Concomitant Topical Psoriasis Treatment
days per weekOffice Based PhototherapyHome Based Phototherapy
All phototypes3.92 ± 2.913.06 ± 2.80
Phototype I/II3.61 ± 2.912.77 ± 2.67
Phototype III/IV4.02 ± 2.853.13 ± 2.88
Phototype V/VI4.65 ± 3.064.23 ± 2.88
All phototypes (week 24)3.59 ± 2.743.34 ± 2.81
Phototype I/II (week 24)3.46 ± 2.673.34 ± 2.71
Phototype III/IV (week 24)3.74 ± 2.783.21 ± 2.88
Phototype V/VI (week 24)3.50 ± 3.013.94 ± 3.21
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.001 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -0.81 · 95% CI -1.27 to -0.35Adjusted for skin phototype
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.0158 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -0.84 · 95% CI -1.51 to -0.16
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.0130 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -0.88 · 95% CI -1.58 to -0.19
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.5910 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -0.41 · 95% CI -1.94 to 1.11
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.395 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): .25 · 95% CI -0.33 to 0.82Adjusted for skin phototype
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.774 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 0.12 · 95% CI -0.69 to 0.93
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.242 (P-value was not adjusted for multiple comparisons.) · Median difference (final values): 0.53 · 95% CI -0.36 to 1.41
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.692 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -0.44 · 95% CI -2.72 to 1.83
SecondaryChanges in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Time frame:
week 12 and week 24 after randomization
Reported as:
Count of participants · Participants
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes - Initiation169
Phototype I/II - Initiation42
Phototype III/IV - Initiation106
Phototype V/VI - Initiation21
All phototypes - Discontinuation89
Phototype I/II - Discontinuation23
Phototype III/IV - Discontinuation56
Phototype V/VI - Discontinuation10
All phototypes - Initiation (Week 24)3128
Phototype I/II - Initiation (Week 24)910
Phototype III/IV - Initiation (Week 24)1714
Phototype V/VI - Initiation (Week 24)54
All phototypes - Discontinuation (Week 24)89
Phototype I/II - Discontinuation (Week 24)23
Phototype III/IV - Discontinuation (Week 24)56
Phototype V/VI - Discontinuation (Week 24)10
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal Standardization · p = 0.1209 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -2.59 · 95% CI -5.86 to 0.68Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.2581 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -2.13 · 95% CI -6.0 to 1.75Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.2952 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -3.04 · 95% CI -8.73 to 2.65Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.6324 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -2.61 · 95% CI -13.12 to 7.89Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.9163 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 0.15 · 95% CI -2.56 to 2.85Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal Standardization · p = 0.8551 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 0.31 · 95% CI -3.03 to 3.66Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.7678 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 0.72 · 95% CI -4.05 to 5.48Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.3446 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -3.03 · 95% CI -8.88 to 2.82Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal Standardization · p = 0.5716 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -1.26 · 95% CI -5.64 to 3.11Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.8756 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -0.44 · 95% CI -6.03 to 5.14Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.5686 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -2.07 · 95% CI -9.18 to 5.04Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.8660 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -1.39 · 95% CI -17.5 to 14.7Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.8779 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 0.19 · 95% CI -2.24 to 2.62Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal Standardization · p = 0.7985 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 0.38 · 95% CI -2.52 to 3.28Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.7585 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 0.69 · 95% CI -3.71 to 5.09Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.3422 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -2.78 · 95% CI -8.15 to 2.59Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
SecondaryPatient-reported Time Spent on Phototherapy Per Treatment

patient reported survey

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Mean · minutes
Patient-reported Time Spent on Phototherapy Per Treatment
minutesOffice Based PhototherapyHome Based Phototherapy
All phototypes21.8 ± 18.218.5 ± 20.9
Phototype I/II21.58 ± 20.4516.32 ± 14.59
Phototype III/IV22.03 ± 16.7718.11 ± 21.14
Phototype V/VI22.06 ± 15.0932.48 ± 38.13
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.094 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -3.20 · 95% CI -6.95 to 0.55Adjusted for skin phototype
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.0393 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -5.26 · 95% CI -10.26 to -0.26
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.1505 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -3.92 · 95% CI -9.28 to 1.44
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.2840 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 10.42 · 95% CI -9.0 to 29.84
SecondaryPatient Reported Costs Associated With Travel for Phototherapy Treatments

patient reported survey for Office patients only

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Mean · USD
Patient Reported Costs Associated With Travel for Phototherapy Treatments
USDOffice Based Phototherapy
All phototypes19.9 ± 61.6
Phototype I/II18.06 ± 57.04
Phototype III/IV23.46 ± 70.71
Phototype V/VI9.22 ± 5.66
Statistical analysis
  • Office Based Phototherapy · Mean: 19.87
  • Office Based Phototherapy · Mean: 18.06
  • Office Based Phototherapy · Mean: 23.46
  • Office Based Phototherapy · Mean: 9.22
SecondaryPatient Reported Time Associated With Travel for Phototherapy Treatments

patient reported survey for Office patients only

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Mean · minutes
Patient Reported Time Associated With Travel for Phototherapy Treatments
minutesOffice Based Phototherapy
All phototypes50.3 ± 46.7
Phototype I/II53.19 ± 50.05
Phototype III/IV49.82 ± 47.43
Phototype V/VI39.72 ± 20.47
Statistical analysis
  • Office Based Phototherapy · Mean: 50.3
  • Office Based Phototherapy · Mean: 53.19
  • Office Based Phototherapy · Mean: 49.82
  • Office Based Phototherapy · Mean: 39.72
SecondaryDLQI (0-1)

Dermatology Life Quality Index (DLQI) score of ≤1 which corresponds to no impact of dermatologic disease on quality of life. DLQI is a 10 item survey that asks patients questions about their health related quality of life on a 0-3 scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Count of participants · Participants
DLQI (0-1)
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes52100
Phototype I/II2556
Phototype III/IV2634
Phototype V/VI110
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 11.97 · 95% CI 6.52 to 17.42Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 16.15 · 95% CI 7.54 to 24.75Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 5.56 · 95% CI -2.35 to 13.46Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 21.37 · 95% CI 7.65 to 35.09Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
SecondaryAchievement of a Minimal Clinically Important Difference (MCID) on the DLQI

A difference of 4 was determined to be the MCID

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Count of participants · Participants
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes130188
Phototype I/II5998
Phototype III/IV5674
Phototype V/VI1516
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.0065 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 11.68 · 95% CI 3.27 to 20.08Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.0478 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 12.31 · 95% CI 0.03 to 24.49Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.0431 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 13.25 · 95% CI 0.52 to 25.98Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.9133 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 1.50 · 95% CI -25.50 to 28.50Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
SecondaryPhysician Global Assessment Times Body Surface Area (PGAxBSA)

The difference in PGAxBSA from baseline to week 12. Values range from -500 to 500, with negative values indicating improvement in disease. BSA is a measure of the body surface area affected by psoriasis using the handprint method in which the palm of the entire hand approximates 1% of the body surface area. PGA is previously described. The product of the two measurements (PGA×BSA) has been investigated to assess psoriasis severity, with higher values indicating greater disease burden. Reference: Chiesa Fuxench et al. Validity of the simple-measure for assessing psoriasis activity (S-MAPA) for objectively evaluating disease severity in patients with plaque psoriasis. J Am Acad Dermatol 2015;73:868-7.

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Mean · units on a scale
Physician Global Assessment Times Body Surface Area (PGAxBSA)
units on a scaleOffice Based PhototherapyHome Based Phototherapy
All phototypes-14.85 ± 37.75-23.26 ± 47.16
Phototype I/II-17.37 ± 33.85-28.04 ± 55.64
Phototype III/IV-14.76 ± 38.78-20.06 ± 37.04
Phototype V/VI-6.11 ± 45.94-14.94 ± 44.72
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.048 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -7.90 · 95% CI -15.73 to -0.07Adjusted for skin phototype
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.1199 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -10.67 · 95% CI -24.15 to 2.80
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.2953 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -5.30 · 95% CI -15.26 to 4.66
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.5124 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -8.83 · 95% CI -35.77 to 18.11
SecondaryPGA x BSA 75%

Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Count of participants · Participants
PGA x BSA 75%
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes94140
Phototype I/II4071
Phototype III/IV4759
Phototype V/VI710
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.0173 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 10.90 · 95% CI 1.93 to 19.87Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.0662 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 13.06 · 95% CI -0.81 to 26.94Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.1976 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 8.58 · 95% CI -4.42 to 21.57Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.3595 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 13.04 · 95% CI -14.60 to 40.69Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
SecondaryPGA x BSA 90%

Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Count of participants · Participants
PGA x BSA 90%
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes68101
Phototype I/II3450
Phototype III/IV3043
Phototype V/VI48
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.0853 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 7.55 · 95% CI -1.05 to 16.14Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.7488 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 2.26 · 95% CI -11.54 to 16.06Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.1051 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 10.12 · 95% CI -2.03 to 22.26Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.1792 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 17.39 · 95% CI -7.48 to 42.27Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
SecondaryDuration of Treatment Response During Observation Period

Defined as the length of time from week 12 to the earliest of DLQI \> 5 or time of initiation of a new systemic treatment or dose escalation of an existing systemic treatment, with patients who maintain DLQI \<=5 5 throughout the 12 week observation period with no new systemic treatments or dose escalation censored at week 24.

Time frame:
24 weeks after randomization
Reported as:
Mean · days
Duration of Treatment Response During Observation Period
daysOffice Based PhototherapyHome Based Phototherapy
All phototypes74.24 ± 19.0277.32 ± 16.95
Phototype I/II76.37 ± 16.2475.96 ± 18.16
Phototype III/IV71.17 ± 22.2378.76 ± 15.39
Phototype V/VI73.5 ± 22.3979.0 ± 16.64
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.175 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 3.07 · 95% CI -1.37 to 7.50Adjusted for skin phototype
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.8904 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): -0.41 · 95% CI -6.34 to 5.51
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.0412 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 7.59 · 95% CI 0.31 to 14.88
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Linear · p = 0.5481 (P-value was not adjusted for multiple comparisons.) · Mean difference (final values): 5.50 · 95% CI -13.38 to 24.38
  • Office Based Phototherapy vs Home Based Phototherapy · Regression, Cox · p = 0.458 · Hazard ratio (hr): 0.813 · 95% CI 0.471 to 1.403Office phototherapy is the reference group.
SecondaryPatients Receiving at Least 80% of Treatments

80% of assigned treatments is defined as 24 total treatments. Patients must have at least one treatment to be included.

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Count of participants · Participants
Patients Receiving at Least 80% of Treatments
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes62202
Phototype I/II34109
Phototype III/IV2282
Phototype V/VI611
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal Standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 38.10 · 95% CI 30.34 to 45.86Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal Standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 38.86 · 95% CI 27.39 to 50.33Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal Standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 42.21 · 95% CI 30.73 to 53.68Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal Standardization · p = 0.2340 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 15.74 · 95% CI -9.63 to 41.11Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
Other pre-specifiedSafety Analysis of Skin Related Events

Burns lasting 48 hours or more

Time frame:
Week 12
Reported as:
Count of participants · Participants
Safety Analysis of Skin Related Events
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes22165
Phototype I/II1177
Phototype III/IV976
Phototype V/VI212
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 43.96 · 95% CI 37.25 to 50.66Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal Standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 39.85 · 95% CI 30.0 to 49.70Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 50.18 · 95% CI 40.09 to 60.27Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = <0.0001 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 36.11 · 95% CI 14.35 to 57.87Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
Other pre-specifiedPhysician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)

The outcome measure is previously described. This analysis repeats the primary outcome of PGA clear/almost clear among patients who received at least 24 treatments (i.e. 80% of assigned treatments).

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Count of participants · Participants
Physician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes3295
Phototype I/II1747
Phototype III/IV1442
Phototype V/VI16
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.1773 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -5.2 · 95% CI -19.4 to 9.0Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.4073 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -6.88 · 95% CI -26.09 to 12.33Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.8247 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): -12.42 · 95% CI -35.24 to 10.41Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.0133 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 37.88 · 95% CI -4.01 to 79.77Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
Other pre-specifiedImpact of Dermatological Disease on Quality of Life ("As Treated" Analysis)

The outcome measure is previously described. This analysis repeats the primary outcome of DLQI \<=5 among patients who received at least 24 treatments (i.e. 80% of assigned treatments).

Time frame:
12 weeks after randomization or earlier at discontinuation of phototherapy
Reported as:
Count of participants · Participants
Impact of Dermatological Disease on Quality of Life ("As Treated" Analysis)
ParticipantsOffice Based PhototherapyHome Based Phototherapy
All phototypes39140
Phototype I/II2279
Phototype III/IV1453
Phototype V/VI38
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.002 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 6.52 · 95% CI -7.11 to 20.14Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.0137 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 7.77 · 95% CI -10.35 to 25.89Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.1656 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 1.0 · 95% CI -21.61 to 23.61Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal standardization · p = 0.1225 (P-value was not adjusted for multiple comparisons.) · Risk difference (rd): 22.73 · 95% CI -25.16 to 70.62Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates
Other pre-specifiedDichotomized DLQI Beyond Week 12

Number of participants that had a DLQI \<= 5 at week 16, week 20, and week 24

Time frame:
From Week 12 to Week 24
Reported as:
Count of participants · Participants
Dichotomized DLQI Beyond Week 12
ParticipantsOffice Based PhototherapyHome Based Phototherapy
Week 1690150
Week 2088118
Week 24105139
Statistical analysis
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal contrast · p = 0.0183 · Risk difference (rd): 0.105 · 95% CI 0.018 to 0.192Positive values indicate higher proportion in the home group.
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal contrast · p = 0.177 · Risk difference (rd): 0.064 · 95% CI -0.029 to 0.158Positive values indicate higher proportion in the home group.
  • Office Based Phototherapy vs Home Based Phototherapy · Marginal contrast · p = 0.815 · Risk difference (rd): -0.011 · 95% CI -0.101 to 0.079Positive values indicate higher proportion in the home group.

Adverse events

Collected over Adverse events were assessed for up to 24 weeks from beginning of study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Office Based Phototherapy0/390 (0%)4/390 (1%)22/390 (5.6%)
Home Based Phototherapy1/393 (0.3%)3/393 (0.8%)165/393 (42%)
Most frequent serious events
Most frequent serious events
EventOffice Based PhototherapyHome Based Phototherapy
CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/3900/393
Hospitalization for infected woundsInfections and infestations1/3900/393
Seen in ER for chest painGeneral disorders1/3900/393
Hospitalization for substance abuse treatmentGeneral disorders0/3901/393
Severe neuropathyNervous system disorders0/3901/393
Hospitalization for blood pressureGeneral disorders0/3901/393
Death (Covid-19 related)Infections and infestations0/3901/393
Malnutrition resulting in hospitalizationGeneral disorders0/3901/393
Most frequent other events
Most frequent other events
EventOffice Based PhototherapyHome Based Phototherapy
Burns from phototherapy treatmentSkin and subcutaneous tissue disorders22/390165/393

Baseline characteristics

Age, Continuous
Age, Continuous(years)Office Based PhototherapyHome Based PhototherapyTotal
Mean47.8 ± 15.148.2 ± 15.948.0 ± 15.5
Sex: Female, Male
Sex: Female, Male(Participants)Office Based PhototherapyHome Based PhototherapyTotal
Female190186376
Male200207407
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Office Based PhototherapyHome Based PhototherapyTotal
Hispanic or Latino5448102
Not Hispanic or Latino328334662
Unknown or Not Reported81119
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Office Based PhototherapyHome Based PhototherapyTotal
Race — White292296588
Race — Black343973
Race — Asian312556
Race — Other333366
Skin Phototype
Skin Phototype(Participants)Office Based PhototherapyHome Based PhototherapyTotal
I/II169181350
III/IV180170350
V/VI414283
Estimated time traveling to/from phototherapy treatment
Estimated time traveling to/from phototherapy treatment(minutes)Office Based PhototherapyHome Based PhototherapyTotal
Mean59.1 ± 50.658.0 ± 42.358.5 ± 46.6
Estimated time traveling to/from dermatologist office
Estimated time traveling to/from dermatologist office(minutes)Office Based PhototherapyHome Based PhototherapyTotal
Mean58.2 ± 47.061.3 ± 49.159.8 ± 48.1
Miles from dermatologist office
Miles from dermatologist office(miles)Office Based PhototherapyHome Based PhototherapyTotal
Mean30.68 ± 35.2132.26 ± 26.1931.48 ± 36.98

11 further baseline measures are reported on the registry.

08

Study locations

38 sites
  • Total Skin & Beauty Dermatology Center
    Birmingham, Alabama 35205, United States
  • Mayo Clinic Arizona
    Scottsdale, Arizona 85259, United States
  • Johnson Dermatology
    Fort Smith, Arkansas 72916, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • George Washington University
    Washington, District of Columbia 20037, United States
  • Howard University
    Washington, District of Columbia 20059, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Dawes Fretzin Clinical Research
    Indianapolis, Indiana 46256, United States
  • MD Claiborne and Associates, LLC
    New Orleans, Louisiana 70115, United States
  • MaineHealth/Maine Medical Center
    Portland, Maine 04102, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
  • DermAssociates LLC
    Silver Spring, Maryland 20902, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Dermatology Specialist of Brighton
    Brighton, Michigan 48114, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Washington University in St. Louis
    Saint Louis, Missouri 63130, United States
  • Psoriasis Treatment Center of Central New Jersey
    East Windsor, New Jersey 08520, United States
  • Heymann, Manders, Green, and Sommer, LLC
    Marlton, New Jersey 08053, United States
  • University of New Mexico
    Albuquerque, New Mexico 87102, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • HHC Kings County Hospital
    Brooklyn, New York 10013, United States
  • SUNY Downstate Health Sciences University
    Brooklyn, New York 11203, United States
  • Buffalo Medical Group
    Buffalo, New York 14221, United States
  • Infinity Dermatology NYC
    Queens, New York 11375, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Ohio State University
    Columbus, Ohio 43215, United States
  • Pennsyvlania Centre For Dermatology
    Exton, Pennsylvania 19341, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Temple University
    Philadelphia, Pennsylvania 19122, United States
  • Dermatology Treatment and Research Center
    Dallas, Texas 75230, United States
  • Menter Dermatology Research Institute
    Dallas, Texas 75246, United States
  • West Houston Dermatology
    Houston, Texas 77082, United States
  • University of Utah
    Salt Lake City, Utah 84112, United States
  • University of Vermont & State Agriculture College
    Burlington, Vermont 05405, United States
  • University of Virginia
    Charlottesville, Virginia 22908, United States
  • Frontier Derm Partners CRO, LLC
    Mill Creek, Washington 98012, United States
  • University of Wisconsin
    Madison, Wisconsin 53715, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 19, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03726489
Lead sponsor
University of Pennsylvania
Collaborators
University of Utah, National Psoriasis Foundation, Patient-Centered Outcomes Research Institute
Responsible party
Sponsor
First posted
Oct 31, 2018
Start date
Mar 1, 2019
Primary completion
Oct 31, 2023
Completion
Dec 30, 2023
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Study contacts

Joel M. Gelfand, MD,MSCE
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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