Psoriasis, Psoriatic Plaque
Conditions
Brief 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
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.
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
Sponsors
University of Utah
National Psoriasis Foundation
Patient-Centered Outcomes Research Institute
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pragmatic, randomized, active comparator effectiveness study
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment (PGA) Score of Clear/Almost Clear | 12 weeks after randomization or earlier at discontinuation of phototherapy | 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). |
| Impact of Dermatological Disease on Quality of Life (DLQI ≤5) | 12 weeks after randomization or earlier at discontinuation of phototherapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Time Associated With Travel for Phototherapy Treatments | 12 weeks after randomization or earlier at discontinuation of phototherapy | patient reported survey for Office patients only |
| PGA x BSA 75% | 12 weeks after randomization or earlier at discontinuation of phototherapy | Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12 |
| PGA x BSA 90% | 12 weeks after randomization or earlier at discontinuation of phototherapy | Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12 |
| Duration of Treatment Response During Observation Period | 24 weeks after randomization | 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. |
| Patients Receiving at Least 80% of Treatments | 12 weeks after randomization or earlier at discontinuation of phototherapy | 80% of assigned treatments is defined as 24 total treatments. Patients must have at least one treatment to be included. |
| Total Number of Phototherapy Treatments Received | 12 weeks after randomization or earlier at discontinuation of phototherapy | patient or site reported phototherapy dosing |
| Cumulative Dose of Phototherapy Received | 12 weeks after randomization or earlier at discontinuation of phototherapy | Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit. |
| Concomitant Topical Psoriasis Treatment | week 12 and week 24 after randomization | Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication |
| Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | week 12 and week 24 after randomization | — |
| Patient-reported Time Spent on Phototherapy Per Treatment | 12 weeks after randomization or earlier at discontinuation of phototherapy | patient reported survey |
| Patient Reported Costs Associated With Travel for Phototherapy Treatments | 12 weeks after randomization or earlier at discontinuation of phototherapy | patient reported survey for Office patients only |
| DLQI (0-1) | 12 weeks after randomization or earlier at discontinuation of phototherapy | 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 |
| Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | 12 weeks after randomization or earlier at discontinuation of phototherapy | A difference of 4 was determined to be the MCID |
| Physician Global Assessment Times Body Surface Area (PGAxBSA) | 12 weeks after randomization or earlier at discontinuation of phototherapy | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dichotomized DLQI Beyond Week 12 | From Week 12 to Week 24 | Number of participants that had a DLQI \<= 5 at week 16, week 20, and week 24 |
| Safety Analysis of Skin Related Events | Week 12 | Burns lasting 48 hours or more |
| Physician Global Assessment (PGA) Score of Clear/Almost Clear (As Treated Analysis) | 12 weeks after randomization or earlier at discontinuation of phototherapy | 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). |
| Impact of Dermatological Disease on Quality of Life (As Treated Analysis) | 12 weeks after randomization or earlier at discontinuation of phototherapy | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Office Based Phototherapy Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
narrow band phototherapy clinic units: Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure | 390 |
| 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.
Daavlin 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 | 393 |
| Total | 783 |
Baseline characteristics
| Characteristic | Total | Office Based Phototherapy | Home Based Phototherapy |
|---|---|---|---|
| Age at psoriasis diagnosis | 32.2 years STANDARD_DEVIATION 18.2 | 32.4 years STANDARD_DEVIATION 17.5 | 32.0 years STANDARD_DEVIATION 18.8 |
| Age, Continuous | 48.0 years STANDARD_DEVIATION 15.5 | 47.8 years STANDARD_DEVIATION 15.1 | 48.2 years STANDARD_DEVIATION 15.9 |
| Baseline DLQI | 12.2 units on a scale (0-30) STANDARD_DEVIATION 7.2 | 12.3 units on a scale (0-30) STANDARD_DEVIATION 7.2 | 12.1 units on a scale (0-30) STANDARD_DEVIATION 7.3 |
| Baseline PGA | 2.7 units on a scale STANDARD_DEVIATION 0.8 | 2.7 units on a scale STANDARD_DEVIATION 0.8 | 2.7 units on a scale STANDARD_DEVIATION 0.8 |
| Body Mass Index | 29.6 kg/m^2 STANDARD_DEVIATION 7.2 | 29.9 kg/m^2 STANDARD_DEVIATION 7.6 | 29.3 kg/m^2 STANDARD_DEVIATION 6.8 |
| BSA | 12.5 percentage STANDARD_DEVIATION 15.7 | 12.4 percentage STANDARD_DEVIATION 15.3 | 12.6 percentage STANDARD_DEVIATION 16.1 |
| Co-pay for dermatologist | 21.6 USD STANDARD_DEVIATION 31.1 | 22.3 USD STANDARD_DEVIATION 31.9 | 21.0 USD STANDARD_DEVIATION 30.3 |
| Co-pay for phototherapy treatment | 17.5 USD STANDARD_DEVIATION 30.4 | 17.5 USD STANDARD_DEVIATION 30.5 | 17.5 USD STANDARD_DEVIATION 30.4 |
| Current treatment Biologics | 55 Participants | 30 Participants | 25 Participants |
| Current treatment Biologics or non-biological systemic therapy | 93 Participants | 49 Participants | 44 Participants |
| Current treatment Non-biological systemic therapy | 45 Participants | 24 Participants | 21 Participants |
| Estimated time traveling to/from dermatologist office | 59.8 minutes STANDARD_DEVIATION 48.1 | 58.2 minutes STANDARD_DEVIATION 47 | 61.3 minutes STANDARD_DEVIATION 49.1 |
| Estimated time traveling to/from phototherapy treatment | 58.5 minutes STANDARD_DEVIATION 46.6 | 59.1 minutes STANDARD_DEVIATION 50.6 | 58.0 minutes STANDARD_DEVIATION 42.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 102 Participants | 54 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 662 Participants | 328 Participants | 334 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants | 8 Participants | 11 Participants |
| Medical history History of anxiety | 62 Participants | 32 Participants | 30 Participants |
| Medical history History of arthritis | 44 Participants | 19 Participants | 25 Participants |
| Medical history History of cardiometabolic disease | 454 Participants | 221 Participants | 233 Participants |
| Medical history History of cardiovascular disease | 52 Participants | 25 Participants | 27 Participants |
| Medical history History of diabetes | 83 Participants | 43 Participants | 40 Participants |
| Medical history History of hyperlipidemia | 113 Participants | 56 Participants | 57 Participants |
| Medical history History of hypertension | 187 Participants | 91 Participants | 96 Participants |
| Medical history History of internal malignancy | 48 Participants | 27 Participants | 21 Participants |
| Medical history History of mood disorder | 75 Participants | 37 Participants | 38 Participants |
| Medical history History of mood disorder/anxiety | 112 Participants | 58 Participants | 54 Participants |
| Medical history History of skin cancer | 11 Participants | 4 Participants | 7 Participants |
| Medical history Pregnant | 1 Participants | 0 Participants | 1 Participants |
| Medical history Psoriatic arthritis present | 133 Participants | 65 Participants | 68 Participants |
| Miles from dermatologist office | 31.48 miles STANDARD_DEVIATION 36.98 | 30.68 miles STANDARD_DEVIATION 35.21 | 32.26 miles STANDARD_DEVIATION 26.19 |
| Psoriasis duration | 15.8 years STANDARD_DEVIATION 14.8 | 15.4 years STANDARD_DEVIATION 14.6 | 16.2 years STANDARD_DEVIATION 15 |
| Race/Ethnicity, Customized Race Asian | 56 Participants | 31 Participants | 25 Participants |
| Race/Ethnicity, Customized Race Black | 73 Participants | 34 Participants | 39 Participants |
| Race/Ethnicity, Customized Race Other | 66 Participants | 33 Participants | 33 Participants |
| Race/Ethnicity, Customized Race White | 588 Participants | 292 Participants | 296 Participants |
| Sex: Female, Male Female | 376 Participants | 190 Participants | 186 Participants |
| Sex: Female, Male Male | 407 Participants | 200 Participants | 207 Participants |
| Skin Phototype I/II | 350 Participants | 169 Participants | 181 Participants |
| Skin Phototype III/IV | 350 Participants | 180 Participants | 170 Participants |
| Skin Phototype V/VI | 83 Participants | 41 Participants | 42 Participants |
| Treatment history Biologics | 167 Participants | 84 Participants | 83 Participants |
| Treatment history Biologics or non-biological systemic therapy | 312 Participants | 155 Participants | 157 Participants |
| Treatment history Non-biological systemic therapy | 231 Participants | 110 Participants | 121 Participants |
| Treatment history Phototherapy | 337 Participants | 165 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 390 | 1 / 393 |
| other Total, other adverse events | 22 / 390 | 165 / 393 |
| serious Total, serious adverse events | 4 / 390 | 3 / 393 |
Outcome results
Primary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | Impact of Dermatological Disease on Quality of Life (DLQI ≤5) | All phototypes | 131 Participants |
| Office Based Phototherapy | Impact of Dermatological Disease on Quality of Life (DLQI ≤5) | Phototype I/II | 65 Participants |
| Office Based Phototherapy | Impact of Dermatological Disease on Quality of Life (DLQI ≤5) | Phototype III/IV | 56 Participants |
| Office Based Phototherapy | Impact of Dermatological Disease on Quality of Life (DLQI ≤5) | Phototype V/VI | 10 Participants |
| Home Based Phototherapy | Impact of Dermatological Disease on Quality of Life (DLQI ≤5) | Phototype V/VI | 17 Participants |
| Home Based Phototherapy | Impact of Dermatological Disease on Quality of Life (DLQI ≤5) | All phototypes | 206 Participants |
| Home Based Phototherapy | Impact of Dermatological Disease on Quality of Life (DLQI ≤5) | Phototype III/IV | 81 Participants |
| Home Based Phototherapy | Impact of Dermatological Disease on Quality of Life (DLQI ≤5) | Phototype I/II | 108 Participants |
Comparison: Overall analysis including all skin phototypesp-value: <0.00195% CI: [11.8, 25.3]Marginal standardization
Comparison: Analysis for Phototypes I/IIp-value: <0.00195% CI: [11, 31.5]Marginal standardization
Comparison: Analysis for Phototypes III/IVp-value: <0.00195% CI: [6.4, 26.6]Marginal standardization
Comparison: Analysis for Phototypes V/VIp-value: 0.00195% CI: [-3.7, 35.9]Marginal standardization
Comparison: Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.p-value: 0.873Regression, Logistic
Primary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear | All phototypes | 100 Participants |
| Office Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear | Phototype I/II | 47 Participants |
| Office Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear | Phototype III/IV | 47 Participants |
| Office Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear | Phototype V/VI | 6 Participants |
| Home Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear | Phototype V/VI | 14 Participants |
| Home Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear | All phototypes | 129 Participants |
| Home Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear | Phototype III/IV | 57 Participants |
| Home Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear | Phototype I/II | 58 Participants |
Comparison: Overall analysis including all skin phototypesp-value: <0.00195% CI: [0.8, 13.5]Marginal standardization
Comparison: Analysis for Phototypes I/IIp-value: <0.00195% CI: [-5.4, 13.8]Marginal standardization
Comparison: Analysis for Phototypes III/IVp-value: <0.00195% CI: [-2.2, 17]Marginal standardization
Comparison: Analysis for Phototypes V/VIp-value: <0.00195% CI: [0.8, 36.6]Marginal standardization
Comparison: Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.p-value: 0.347Regression, Logistic
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | All phototypes | 130 Participants |
| Office Based Phototherapy | Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | Phototype I/II | 59 Participants |
| Office Based Phototherapy | Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | Phototype III/IV | 56 Participants |
| Office Based Phototherapy | Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | Phototype V/VI | 15 Participants |
| Home Based Phototherapy | Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | Phototype V/VI | 16 Participants |
| Home Based Phototherapy | Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | All phototypes | 188 Participants |
| Home Based Phototherapy | Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | Phototype III/IV | 74 Participants |
| Home Based Phototherapy | Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | Phototype I/II | 98 Participants |
Comparison: Overall analysis adjusted for all skin phototypesp-value: 0.006595% CI: [3.27, 20.08]Marginal standardization
Comparison: Analysis for Phototypes I/IIp-value: 0.047895% CI: [0.03, 24.49]Marginal standardization
Comparison: Analysis for Phototypes III/IVp-value: 0.043195% CI: [0.52, 25.98]Marginal standardization
Comparison: Analysis for Phototypes V/VIp-value: 0.913395% CI: [-25.5, 28.5]Marginal standardization
Secondary
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Time frame: week 12 and week 24 after randomization
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | All phototypes - Initiation | 16 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype I/II - Initiation | 4 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype III/IV - Initiation | 10 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype V/VI - Initiation | 2 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | All phototypes - Discontinuation | 8 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype I/II - Discontinuation | 2 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype III/IV - Discontinuation | 5 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype V/VI - Discontinuation | 1 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | All phototypes - Initiation (Week 24) | 31 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype I/II - Initiation (Week 24) | 9 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype III/IV - Initiation (Week 24) | 17 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype V/VI - Initiation (Week 24) | 5 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | All phototypes - Discontinuation (Week 24) | 8 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype I/II - Discontinuation (Week 24) | 2 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype III/IV - Discontinuation (Week 24) | 5 Participants |
| Office Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype V/VI - Discontinuation (Week 24) | 1 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype V/VI - Discontinuation (Week 24) | 0 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | All phototypes - Initiation | 9 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | All phototypes - Initiation (Week 24) | 28 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype I/II - Initiation | 2 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | All phototypes - Discontinuation (Week 24) | 9 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype III/IV - Initiation | 6 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype I/II - Initiation (Week 24) | 10 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype V/VI - Initiation | 1 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype III/IV - Discontinuation (Week 24) | 6 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | All phototypes - Discontinuation | 9 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype III/IV - Initiation (Week 24) | 14 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype I/II - Discontinuation | 3 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype I/II - Discontinuation (Week 24) | 3 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype III/IV - Discontinuation | 6 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype V/VI - Initiation (Week 24) | 4 Participants |
| Home Based Phototherapy | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | Phototype V/VI - Discontinuation | 0 Participants |
Comparison: Overall analysis adjusted for all skin phototypes - Initiationp-value: 0.120995% CI: [-5.86, 0.68]Marginal Standardization
Comparison: Analysis for Phototypes I/II - Initiationp-value: 0.258195% CI: [-6, 1.75]Marginal standardization
Comparison: Analysis for Phototypes III/IV - Initiationp-value: 0.295295% CI: [-8.73, 2.65]Marginal standardization
Comparison: Analysis for Phototypes V/VI - Initiationp-value: 0.632495% CI: [-13.12, 7.89]Marginal standardization
Comparison: Overall analysis adjusted for all skin phototypes - Discontinuationp-value: 0.916395% CI: [-2.56, 2.85]Marginal standardization
Comparison: Analysis for Phototypes I/II - Discontinuationp-value: 0.855195% CI: [-3.03, 3.66]Marginal Standardization
Comparison: Analysis for Phototypes III/IV - Discontinuationp-value: 0.767895% CI: [-4.05, 5.48]Marginal standardization
Comparison: Analysis for Phototypes V/VI - Discontinuationp-value: 0.344695% CI: [-8.88, 2.82]Marginal standardization
Comparison: Overall analysis adjusted for all skin phototypes - Initiation at Week 24p-value: 0.571695% CI: [-5.64, 3.11]Marginal Standardization
Comparison: Analysis for Phototypes I/II - Initiation at Week 24p-value: 0.875695% CI: [-6.03, 5.14]Marginal standardization
Comparison: Analysis for Phototypes III/IV - Initiation at Week 24p-value: 0.568695% CI: [-9.18, 5.04]Marginal standardization
Comparison: Analysis for Phototypes V/VI - Initiation at Week 24p-value: 0.86695% CI: [-17.5, 14.7]Marginal standardization
Comparison: Overall analysis adjusted for all skin phototypes - Discontinuation at Week 24p-value: 0.877995% CI: [-2.24, 2.62]Marginal standardization
Comparison: Analysis for Phototypes I/II - Discontinuation at Week 24p-value: 0.798595% CI: [-2.52, 3.28]Marginal Standardization
Comparison: Analysis for Phototypes III/IV - Discontinuation at Week 24p-value: 0.758595% CI: [-3.71, 5.09]Marginal standardization
Comparison: Analysis for Phototypes V/VI - Discontinuation at Week 24p-value: 0.342295% CI: [-8.15, 2.59]Marginal standardization
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Office Based Phototherapy | Concomitant Topical Psoriasis Treatment | All phototypes | 3.92 days per week | Standard Deviation 2.91 |
| Office Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype I/II | 3.61 days per week | Standard Deviation 2.91 |
| Office Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype III/IV | 4.02 days per week | Standard Deviation 2.85 |
| Office Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype V/VI | 4.65 days per week | Standard Deviation 3.06 |
| Office Based Phototherapy | Concomitant Topical Psoriasis Treatment | All phototypes (week 24) | 3.59 days per week | Standard Deviation 2.74 |
| Office Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype I/II (week 24) | 3.46 days per week | Standard Deviation 2.67 |
| Office Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype III/IV (week 24) | 3.74 days per week | Standard Deviation 2.78 |
| Office Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype V/VI (week 24) | 3.50 days per week | Standard Deviation 3.01 |
| Home Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype V/VI (week 24) | 3.94 days per week | Standard Deviation 3.21 |
| Home Based Phototherapy | Concomitant Topical Psoriasis Treatment | All phototypes | 3.06 days per week | Standard Deviation 2.8 |
| Home Based Phototherapy | Concomitant Topical Psoriasis Treatment | All phototypes (week 24) | 3.34 days per week | Standard Deviation 2.81 |
| Home Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype I/II | 2.77 days per week | Standard Deviation 2.67 |
| Home Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype III/IV (week 24) | 3.21 days per week | Standard Deviation 2.88 |
| Home Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype III/IV | 3.13 days per week | Standard Deviation 2.88 |
| Home Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype I/II (week 24) | 3.34 days per week | Standard Deviation 2.71 |
| Home Based Phototherapy | Concomitant Topical Psoriasis Treatment | Phototype V/VI | 4.23 days per week | Standard Deviation 2.88 |
Comparison: Overall analysis adjusted for all skin phototypesp-value: 0.00195% CI: [-1.27, -0.35]Regression, Linear
Comparison: Analysis for Phototypes I/IIp-value: 0.015895% CI: [-1.51, -0.16]Regression, Linear
Comparison: Analysis for Phototypes III/IVp-value: 0.01395% CI: [-1.58, -0.19]Regression, Linear
Comparison: Analysis for Phototypes V/VIp-value: 0.59195% CI: [-1.94, 1.11]Regression, Linear
Comparison: Overall analysis adjusted for all skin phototypes at Week 24p-value: 0.39595% CI: [-0.33, 0.82]Regression, Linear
Comparison: Analysis for Phototypes I/II at Week 24p-value: 0.77495% CI: [-0.69, 0.93]Regression, Linear
Comparison: Analysis for Phototypes III/IV at Week 24p-value: 0.24295% CI: [-0.36, 1.41]Regression, Linear
Comparison: Analysis for Phototypes V/VI at Week 24p-value: 0.69295% CI: [-2.72, 1.83]Regression, Linear
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Office Based Phototherapy | Cumulative Dose of Phototherapy Received | All phototypes | 17.27 J/cm^2 | Standard Deviation 16.09 |
| Office Based Phototherapy | Cumulative Dose of Phototherapy Received | Phototype III/IV | 18.93 J/cm^2 | Standard Deviation 16.79 |
| Office Based Phototherapy | Cumulative Dose of Phototherapy Received | Phototype I/II | 15.04 J/cm^2 | Standard Deviation 13.19 |
| Office Based Phototherapy | Cumulative Dose of Phototherapy Received | Phototype V/VI | 19.90 J/cm^2 | Standard Deviation 22.86 |
| Home Based Phototherapy | Cumulative Dose of Phototherapy Received | Phototype I/II | 26.51 J/cm^2 | Standard Deviation 20.94 |
| Home Based Phototherapy | Cumulative Dose of Phototherapy Received | All phototypes | 31.43 J/cm^2 | Standard Deviation 29.55 |
| Home Based Phototherapy | Cumulative Dose of Phototherapy Received | Phototype V/VI | 52.73 J/cm^2 | Standard Deviation 58.29 |
| Home Based Phototherapy | Cumulative Dose of Phototherapy Received | Phototype III/IV | 32.80 J/cm^2 | Standard Deviation 27.64 |
Comparison: Overall analysis adjusted for all skin phototypesp-value: <0.000195% CI: [10.4, 18.7]Regression, Linear
Comparison: Analysis for Phototypes I/IIp-value: <0.000195% CI: [6.93, 16.01]Regression, Linear
Comparison: Analysis for Phototypes III/IVp-value: <0.000195% CI: [7.77, 19.98]Regression, Linear
Comparison: Analysis for Phototypes V/VIp-value: 0.012795% CI: [7.32, 58.35]Regression, Linear
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | DLQI (0-1) | Phototype V/VI | 1 Participants |
| Office Based Phototherapy | DLQI (0-1) | All phototypes | 52 Participants |
| Office Based Phototherapy | DLQI (0-1) | Phototype I/II | 25 Participants |
| Office Based Phototherapy | DLQI (0-1) | Phototype III/IV | 26 Participants |
| Home Based Phototherapy | DLQI (0-1) | Phototype III/IV | 34 Participants |
| Home Based Phototherapy | DLQI (0-1) | Phototype V/VI | 10 Participants |
| Home Based Phototherapy | DLQI (0-1) | Phototype I/II | 56 Participants |
| Home Based Phototherapy | DLQI (0-1) | All phototypes | 100 Participants |
Comparison: Overall analysis adjusted for all skin phototypesp-value: <0.000195% CI: [6.52, 17.42]Marginal standardization
Comparison: Analysis for Phototypes I/IIp-value: <0.000195% CI: [7.54, 24.75]Marginal standardization
Comparison: Analysis for Phototypes III/IVp-value: <0.000195% CI: [-2.35, 13.46]Marginal standardization
Comparison: Analysis for Phototypes V/VIp-value: <0.000195% CI: [7.65, 35.09]Marginal standardization
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Office Based Phototherapy | Duration of Treatment Response During Observation Period | All phototypes | 74.24 days | Standard Deviation 19.02 |
| Office Based Phototherapy | Duration of Treatment Response During Observation Period | Phototype I/II | 76.37 days | Standard Deviation 16.24 |
| Office Based Phototherapy | Duration of Treatment Response During Observation Period | Phototype III/IV | 71.17 days | Standard Deviation 22.23 |
| Office Based Phototherapy | Duration of Treatment Response During Observation Period | Phototype V/VI | 73.5 days | Standard Deviation 22.39 |
| Home Based Phototherapy | Duration of Treatment Response During Observation Period | Phototype V/VI | 79.0 days | Standard Deviation 16.64 |
| Home Based Phototherapy | Duration of Treatment Response During Observation Period | All phototypes | 77.32 days | Standard Deviation 16.95 |
| Home Based Phototherapy | Duration of Treatment Response During Observation Period | Phototype III/IV | 78.76 days | Standard Deviation 15.39 |
| Home Based Phototherapy | Duration of Treatment Response During Observation Period | Phototype I/II | 75.96 days | Standard Deviation 18.16 |
Comparison: Overall analysis adjusted for all skin phototypesp-value: 0.17595% CI: [-1.37, 7.5]Regression, Linear
Comparison: Analysis for Phototypes I/IIp-value: 0.890495% CI: [-6.34, 5.51]Regression, Linear
Comparison: Analysis for Phototypes III/IVp-value: 0.041295% CI: [0.31, 14.88]Regression, Linear
Comparison: Analysis for Phototypes V/VIp-value: 0.548195% CI: [-13.38, 24.38]Regression, Linear
Comparison: Cox proportional hazards model for maintaining treatment response after week 12.p-value: 0.45895% CI: [0.471, 1.403]Regression, Cox
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Office Based Phototherapy | Patient Reported Costs Associated With Travel for Phototherapy Treatments | All phototypes | 19.9 USD | Standard Deviation 61.6 |
| Office Based Phototherapy | Patient Reported Costs Associated With Travel for Phototherapy Treatments | Phototype I/II | 18.06 USD | Standard Deviation 57.04 |
| Office Based Phototherapy | Patient Reported Costs Associated With Travel for Phototherapy Treatments | Phototype III/IV | 23.46 USD | Standard Deviation 70.71 |
| Office Based Phototherapy | Patient Reported Costs Associated With Travel for Phototherapy Treatments | Phototype V/VI | 9.22 USD | Standard Deviation 5.66 |
Comparison: Overall analysis adjusted for all skin phototypes
Comparison: Analysis for Phototypes I/II
Comparison: Analysis for Phototypes III/IV
Comparison: Analysis for Phototypes V/VI
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Office Based Phototherapy | Patient Reported Time Associated With Travel for Phototherapy Treatments | All phototypes | 50.3 minutes | Standard Deviation 46.7 |
| Office Based Phototherapy | Patient Reported Time Associated With Travel for Phototherapy Treatments | Phototype I/II | 53.19 minutes | Standard Deviation 50.05 |
| Office Based Phototherapy | Patient Reported Time Associated With Travel for Phototherapy Treatments | Phototype III/IV | 49.82 minutes | Standard Deviation 47.43 |
| Office Based Phototherapy | Patient Reported Time Associated With Travel for Phototherapy Treatments | Phototype V/VI | 39.72 minutes | Standard Deviation 20.47 |
Comparison: Overall analysis adjusted for all skin phototypes
Comparison: Analysis for Phototypes I/II
Comparison: Analysis for Phototypes III/IV
Comparison: Analysis for Phototypes V/VI
Secondary
Patient-reported Time Spent on Phototherapy Per Treatment
patient reported survey
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Office Based Phototherapy | Patient-reported Time Spent on Phototherapy Per Treatment | All phototypes | 21.8 minutes | Standard Deviation 18.2 |
| Office Based Phototherapy | Patient-reported Time Spent on Phototherapy Per Treatment | Phototype I/II | 21.58 minutes | Standard Deviation 20.45 |
| Office Based Phototherapy | Patient-reported Time Spent on Phototherapy Per Treatment | Phototype III/IV | 22.03 minutes | Standard Deviation 16.77 |
| Office Based Phototherapy | Patient-reported Time Spent on Phototherapy Per Treatment | Phototype V/VI | 22.06 minutes | Standard Deviation 15.09 |
| Home Based Phototherapy | Patient-reported Time Spent on Phototherapy Per Treatment | Phototype V/VI | 32.48 minutes | Standard Deviation 38.13 |
| Home Based Phototherapy | Patient-reported Time Spent on Phototherapy Per Treatment | All phototypes | 18.5 minutes | Standard Deviation 20.9 |
| Home Based Phototherapy | Patient-reported Time Spent on Phototherapy Per Treatment | Phototype III/IV | 18.11 minutes | Standard Deviation 21.14 |
| Home Based Phototherapy | Patient-reported Time Spent on Phototherapy Per Treatment | Phototype I/II | 16.32 minutes | Standard Deviation 14.59 |
Comparison: Overall analysis adjusted for all skin phototypesp-value: 0.09495% CI: [-6.95, 0.55]Regression, Linear
Comparison: Analysis for Phototypes I/IIp-value: 0.039395% CI: [-10.26, -0.26]Regression, Linear
Comparison: Analysis for Phototypes III/IVp-value: 0.150595% CI: [-9.28, 1.44]Regression, Linear
Comparison: Analysis for Phototypes V/VIp-value: 0.28495% CI: [-9, 29.84]Regression, Linear
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | Patients Receiving at Least 80% of Treatments | All phototypes | 62 Participants |
| Office Based Phototherapy | Patients Receiving at Least 80% of Treatments | Phototype I/II | 34 Participants |
| Office Based Phototherapy | Patients Receiving at Least 80% of Treatments | Phototype III/IV | 22 Participants |
| Office Based Phototherapy | Patients Receiving at Least 80% of Treatments | Phototype V/VI | 6 Participants |
| Home Based Phototherapy | Patients Receiving at Least 80% of Treatments | Phototype V/VI | 11 Participants |
| Home Based Phototherapy | Patients Receiving at Least 80% of Treatments | All phototypes | 202 Participants |
| Home Based Phototherapy | Patients Receiving at Least 80% of Treatments | Phototype III/IV | 82 Participants |
| Home Based Phototherapy | Patients Receiving at Least 80% of Treatments | Phototype I/II | 109 Participants |
Comparison: Overall analysis adjusted for all skin phototypesp-value: <0.000195% CI: [30.34, 45.86]Marginal Standardization
Comparison: Analysis for Phototypes I/IIp-value: <0.000195% CI: [27.39, 50.33]Marginal Standardization
Comparison: Analysis for Phototypes III/IVp-value: <0.000195% CI: [30.73, 53.68]Marginal Standardization
Comparison: Analysis for Phototypes V/VIp-value: 0.23495% CI: [-9.63, 41.11]Marginal Standardization
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | PGA x BSA 75% | All phototypes | 94 Participants |
| Office Based Phototherapy | PGA x BSA 75% | Phototype I/II | 40 Participants |
| Office Based Phototherapy | PGA x BSA 75% | Phototype III/IV | 47 Participants |
| Office Based Phototherapy | PGA x BSA 75% | Phototype V/VI | 7 Participants |
| Home Based Phototherapy | PGA x BSA 75% | Phototype V/VI | 10 Participants |
| Home Based Phototherapy | PGA x BSA 75% | All phototypes | 140 Participants |
| Home Based Phototherapy | PGA x BSA 75% | Phototype III/IV | 59 Participants |
| Home Based Phototherapy | PGA x BSA 75% | Phototype I/II | 71 Participants |
Comparison: Overall analysis adjusted for all skin phototypesp-value: 0.017395% CI: [1.93, 19.87]Marginal standardization
Comparison: Analysis for Phototypes I/IIp-value: 0.066295% CI: [-0.81, 26.94]Marginal standardization
Comparison: Analysis for Phototypes III/IVp-value: 0.197695% CI: [-4.42, 21.57]Marginal standardization
Comparison: Analysis for Phototypes V/VIp-value: 0.359595% CI: [-14.6, 40.69]Marginal standardization
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | PGA x BSA 90% | All phototypes | 68 Participants |
| Office Based Phototherapy | PGA x BSA 90% | Phototype I/II | 34 Participants |
| Office Based Phototherapy | PGA x BSA 90% | Phototype III/IV | 30 Participants |
| Office Based Phototherapy | PGA x BSA 90% | Phototype V/VI | 4 Participants |
| Home Based Phototherapy | PGA x BSA 90% | Phototype V/VI | 8 Participants |
| Home Based Phototherapy | PGA x BSA 90% | All phototypes | 101 Participants |
| Home Based Phototherapy | PGA x BSA 90% | Phototype III/IV | 43 Participants |
| Home Based Phototherapy | PGA x BSA 90% | Phototype I/II | 50 Participants |
Comparison: Overall analysis adjusted for all skin phototypesp-value: 0.085395% CI: [-1.05, 16.14]Marginal standardization
Comparison: Analysis for Phototypes I/IIp-value: 0.748895% CI: [-11.54, 16.06]Marginal standardization
Comparison: Analysis for Phototypes III/IVp-value: 0.105195% CI: [-2.03, 22.26]Marginal standardization
Comparison: Analysis for Phototypes V/VIp-value: 0.179295% CI: [-7.48, 42.27]Marginal standardization
Secondary
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Office Based Phototherapy | Physician Global Assessment Times Body Surface Area (PGAxBSA) | All phototypes | -14.85 units on a scale | Standard Deviation 37.75 |
| Office Based Phototherapy | Physician Global Assessment Times Body Surface Area (PGAxBSA) | Phototype I/II | -17.37 units on a scale | Standard Deviation 33.85 |
| Office Based Phototherapy | Physician Global Assessment Times Body Surface Area (PGAxBSA) | Phototype III/IV | -14.76 units on a scale | Standard Deviation 38.78 |
| Office Based Phototherapy | Physician Global Assessment Times Body Surface Area (PGAxBSA) | Phototype V/VI | -6.11 units on a scale | Standard Deviation 45.94 |
| Home Based Phototherapy | Physician Global Assessment Times Body Surface Area (PGAxBSA) | Phototype V/VI | -14.94 units on a scale | Standard Deviation 44.72 |
| Home Based Phototherapy | Physician Global Assessment Times Body Surface Area (PGAxBSA) | All phototypes | -23.26 units on a scale | Standard Deviation 47.16 |
| Home Based Phototherapy | Physician Global Assessment Times Body Surface Area (PGAxBSA) | Phototype III/IV | -20.06 units on a scale | Standard Deviation 37.04 |
| Home Based Phototherapy | Physician Global Assessment Times Body Surface Area (PGAxBSA) | Phototype I/II | -28.04 units on a scale | Standard Deviation 55.64 |
Comparison: Overall analysis adjusted for all skin phototypesp-value: 0.04895% CI: [-15.73, -0.07]Regression, Linear
Comparison: Analysis for Phototypes I/IIp-value: 0.119995% CI: [-24.15, 2.8]Regression, Linear
Comparison: Analysis for Phototypes III/IVp-value: 0.295395% CI: [-15.26, 4.66]Regression, Linear
Comparison: Analysis for Phototypes V/VIp-value: 0.512495% CI: [-35.77, 18.11]Regression, Linear
Secondary
Total Number of Phototherapy Treatments Received
patient or site reported phototherapy dosing
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Office Based Phototherapy | Total Number of Phototherapy Treatments Received | All phototypes | 17.95 treatments | Standard Deviation 8.83 |
| Office Based Phototherapy | Total Number of Phototherapy Treatments Received | Phototype I/II | 18.86 treatments | Standard Deviation 8.99 |
| Office Based Phototherapy | Total Number of Phototherapy Treatments Received | Phototype III/IV | 17.72 treatments | Standard Deviation 8.49 |
| Office Based Phototherapy | Total Number of Phototherapy Treatments Received | Phototype V/VI | 14.96 treatments | Standard Deviation 9.15 |
| Home Based Phototherapy | Total Number of Phototherapy Treatments Received | Phototype V/VI | 21.78 treatments | Standard Deviation 11.07 |
| Home Based Phototherapy | Total Number of Phototherapy Treatments Received | All phototypes | 26.82 treatments | Standard Deviation 10.63 |
| Home Based Phototherapy | Total Number of Phototherapy Treatments Received | Phototype III/IV | 26.20 treatments | Standard Deviation 11.4 |
| Home Based Phototherapy | Total Number of Phototherapy Treatments Received | Phototype I/II | 28.24 treatments | Standard Deviation 9.57 |
Comparison: Overall analysis adjusted for all skin phototypesp-value: <0.000195% CI: [7.1, 10.4]Regression, Linear
Comparison: Analysis for Phototypes I/IIp-value: <0.000195% CI: [7.05, 11.71]Regression, Linear
Comparison: Analysis for Phototypes III/IVp-value: <0.000195% CI: [5.82, 11.14]Regression, Linear
Comparison: Analysis for Phototypes V/VIp-value: 0.021395% CI: [1.06, 12.58]Regression, Linear
Other Pre-specified
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
Population: The number analyzed per time point differ due to missing DLQI response
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | Dichotomized DLQI Beyond Week 12 | Week 16 | 90 Participants |
| Office Based Phototherapy | Dichotomized DLQI Beyond Week 12 | Week 20 | 88 Participants |
| Office Based Phototherapy | Dichotomized DLQI Beyond Week 12 | Week 24 | 105 Participants |
| Home Based Phototherapy | Dichotomized DLQI Beyond Week 12 | Week 16 | 150 Participants |
| Home Based Phototherapy | Dichotomized DLQI Beyond Week 12 | Week 20 | 118 Participants |
| Home Based Phototherapy | Dichotomized DLQI Beyond Week 12 | Week 24 | 139 Participants |
Comparison: Difference of proportion at week 16. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.p-value: 0.018395% CI: [0.018, 0.192]Marginal contrast
Comparison: Difference of proportion at week 20. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.p-value: 0.17795% CI: [-0.029, 0.158]Marginal contrast
Comparison: Difference of proportion at week 24. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.p-value: 0.81595% CI: [-0.101, 0.079]Marginal contrast
Other Pre-specified
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | Impact of Dermatological Disease on Quality of Life (As Treated Analysis) | All phototypes | 39 Participants |
| Office Based Phototherapy | Impact of Dermatological Disease on Quality of Life (As Treated Analysis) | Phototype I/II | 22 Participants |
| Office Based Phototherapy | Impact of Dermatological Disease on Quality of Life (As Treated Analysis) | Phototype III/IV | 14 Participants |
| Office Based Phototherapy | Impact of Dermatological Disease on Quality of Life (As Treated Analysis) | Phototype V/VI | 3 Participants |
| Home Based Phototherapy | Impact of Dermatological Disease on Quality of Life (As Treated Analysis) | Phototype V/VI | 8 Participants |
| Home Based Phototherapy | Impact of Dermatological Disease on Quality of Life (As Treated Analysis) | All phototypes | 140 Participants |
| Home Based Phototherapy | Impact of Dermatological Disease on Quality of Life (As Treated Analysis) | Phototype III/IV | 53 Participants |
| Home Based Phototherapy | Impact of Dermatological Disease on Quality of Life (As Treated Analysis) | Phototype I/II | 79 Participants |
Comparison: Overall analysis including all skin phototypesp-value: 0.00295% CI: [-7.11, 20.14]Marginal standardization
Comparison: Analysis for Phototypes I/IIp-value: 0.013795% CI: [-10.35, 25.89]Marginal standardization
Comparison: Analysis for Phototypes III/IVp-value: 0.165695% CI: [-21.61, 23.61]Marginal standardization
Comparison: Analysis for Phototypes V/VIp-value: 0.122595% CI: [-25.16, 70.62]Marginal standardization
Other Pre-specified
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
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear (As Treated Analysis) | All phototypes | 32 Participants |
| Office Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear (As Treated Analysis) | Phototype I/II | 17 Participants |
| Office Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear (As Treated Analysis) | Phototype III/IV | 14 Participants |
| Office Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear (As Treated Analysis) | Phototype V/VI | 1 Participants |
| Home Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear (As Treated Analysis) | Phototype V/VI | 6 Participants |
| Home Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear (As Treated Analysis) | All phototypes | 95 Participants |
| Home Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear (As Treated Analysis) | Phototype III/IV | 42 Participants |
| Home Based Phototherapy | Physician Global Assessment (PGA) Score of Clear/Almost Clear (As Treated Analysis) | Phototype I/II | 47 Participants |
Comparison: Overall analysis including all skin phototypesp-value: 0.177395% CI: [-19.4, 9]Marginal standardization
Comparison: Analysis for Phototypes I/IIp-value: 0.407395% CI: [-26.09, 12.33]Marginal standardization
Comparison: Analysis for Phototypes III/IVp-value: 0.824795% CI: [-35.24, 10.41]Marginal standardization
Comparison: Analysis for Phototypes V/VIp-value: 0.013395% CI: [-4.01, 79.77]Marginal standardization
Other Pre-specified
Safety Analysis of Skin Related Events
Burns lasting 48 hours or more
Time frame: Week 12
Population: The outcome measures were analyzed by skin phototype strata in addition to total subjects. Participants with missing data were excluded from the overall number of participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Office Based Phototherapy | Safety Analysis of Skin Related Events | All phototypes | 22 Participants |
| Office Based Phototherapy | Safety Analysis of Skin Related Events | Phototype I/II | 11 Participants |
| Office Based Phototherapy | Safety Analysis of Skin Related Events | Phototype III/IV | 9 Participants |
| Office Based Phototherapy | Safety Analysis of Skin Related Events | Phototype V/VI | 2 Participants |
| Home Based Phototherapy | Safety Analysis of Skin Related Events | Phototype V/VI | 12 Participants |
| Home Based Phototherapy | Safety Analysis of Skin Related Events | All phototypes | 165 Participants |
| Home Based Phototherapy | Safety Analysis of Skin Related Events | Phototype III/IV | 76 Participants |
| Home Based Phototherapy | Safety Analysis of Skin Related Events | Phototype I/II | 77 Participants |
Comparison: Overall analysis including all skin phototypesp-value: <0.000195% CI: [37.25, 50.66]Marginal standardization
Comparison: Analysis for Phototypes I/IIp-value: <0.000195% CI: [30, 49.7]Marginal Standardization
Comparison: Analysis for Phototypes III/IVp-value: <0.000195% CI: [40.09, 60.27]Marginal standardization
Comparison: Analysis for Phototypes V/VIp-value: <0.000195% CI: [14.35, 57.87]Marginal standardization