Trial Outcomes & Findings for Light Treatment Effectiveness (LITE) Study (NCT NCT03726489)
NCT ID: NCT03726489
Last Updated: 2024-09-19
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
783 participants
Primary outcome timeframe
12 weeks after randomization or earlier at discontinuation of phototherapy
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
390
|
393
|
|
Overall Study
Received Phototherapy
|
232
|
309
|
|
Overall Study
DLQI Assessed
|
252
|
308
|
|
Overall Study
PGA Assessed
|
217
|
255
|
|
Overall Study
COMPLETED
|
390
|
393
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data due to survey non-response
Baseline characteristics by cohort
| Measure |
Office Based Phototherapy
n=390 Participants
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
|
Home Based Phototherapy
n=393 Participants
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
|
Total
n=783 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 15.1 • n=390 Participants
|
48.2 years
STANDARD_DEVIATION 15.9 • n=393 Participants
|
48.0 years
STANDARD_DEVIATION 15.5 • n=783 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=390 Participants
|
186 Participants
n=393 Participants
|
376 Participants
n=783 Participants
|
|
Sex: Female, Male
Male
|
200 Participants
n=390 Participants
|
207 Participants
n=393 Participants
|
407 Participants
n=783 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=390 Participants
|
48 Participants
n=393 Participants
|
102 Participants
n=783 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
328 Participants
n=390 Participants
|
334 Participants
n=393 Participants
|
662 Participants
n=783 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=390 Participants
|
11 Participants
n=393 Participants
|
19 Participants
n=783 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
292 Participants
n=390 Participants
|
296 Participants
n=393 Participants
|
588 Participants
n=783 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
34 Participants
n=390 Participants
|
39 Participants
n=393 Participants
|
73 Participants
n=783 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
31 Participants
n=390 Participants
|
25 Participants
n=393 Participants
|
56 Participants
n=783 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
33 Participants
n=390 Participants
|
33 Participants
n=393 Participants
|
66 Participants
n=783 Participants
|
|
Skin Phototype
I/II
|
169 Participants
n=390 Participants
|
181 Participants
n=393 Participants
|
350 Participants
n=783 Participants
|
|
Skin Phototype
III/IV
|
180 Participants
n=390 Participants
|
170 Participants
n=393 Participants
|
350 Participants
n=783 Participants
|
|
Skin Phototype
V/VI
|
41 Participants
n=390 Participants
|
42 Participants
n=393 Participants
|
83 Participants
n=783 Participants
|
|
Estimated time traveling to/from phototherapy treatment
|
59.1 minutes
STANDARD_DEVIATION 50.6 • n=328 Participants • Missing data due to survey non-response
|
58.0 minutes
STANDARD_DEVIATION 42.3 • n=324 Participants • Missing data due to survey non-response
|
58.5 minutes
STANDARD_DEVIATION 46.6 • n=652 Participants • Missing data due to survey non-response
|
|
Estimated time traveling to/from dermatologist office
|
58.2 minutes
STANDARD_DEVIATION 47.0 • n=328 Participants • Missing data due to survey non-response
|
61.3 minutes
STANDARD_DEVIATION 49.1 • n=324 Participants • Missing data due to survey non-response
|
59.8 minutes
STANDARD_DEVIATION 48.1 • n=652 Participants • Missing data due to survey non-response
|
|
Miles from dermatologist office
|
30.68 miles
STANDARD_DEVIATION 35.21 • n=328 Participants • Missing data due to non-response
|
32.26 miles
STANDARD_DEVIATION 26.19 • n=324 Participants • Missing data due to non-response
|
31.48 miles
STANDARD_DEVIATION 36.98 • n=652 Participants • Missing data due to non-response
|
|
Co-pay for dermatologist
|
22.3 USD
STANDARD_DEVIATION 31.9 • n=385 Participants • Missing data due to survey non-response
|
21.0 USD
STANDARD_DEVIATION 30.3 • n=388 Participants • Missing data due to survey non-response
|
21.6 USD
STANDARD_DEVIATION 31.1 • n=773 Participants • Missing data due to survey non-response
|
|
Co-pay for phototherapy treatment
|
17.5 USD
STANDARD_DEVIATION 30.5 • n=385 Participants • Missing data due to survey non-response
|
17.5 USD
STANDARD_DEVIATION 30.4 • n=388 Participants • Missing data due to survey non-response
|
17.5 USD
STANDARD_DEVIATION 30.4 • n=773 Participants • Missing data due to survey non-response
|
|
Body Mass Index
|
29.9 kg/m^2
STANDARD_DEVIATION 7.6 • n=390 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 6.8 • n=393 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 7.2 • n=783 Participants
|
|
Medical history
Psoriatic arthritis present
|
65 Participants
n=390 Participants
|
68 Participants
n=393 Participants
|
133 Participants
n=783 Participants
|
|
Medical history
History of internal malignancy
|
27 Participants
n=390 Participants
|
21 Participants
n=393 Participants
|
48 Participants
n=783 Participants
|
|
Medical history
History of skin cancer
|
4 Participants
n=390 Participants
|
7 Participants
n=393 Participants
|
11 Participants
n=783 Participants
|
|
Medical history
History of cardiovascular disease
|
25 Participants
n=390 Participants
|
27 Participants
n=393 Participants
|
52 Participants
n=783 Participants
|
|
Medical history
History of diabetes
|
43 Participants
n=390 Participants
|
40 Participants
n=393 Participants
|
83 Participants
n=783 Participants
|
|
Medical history
History of hypertension
|
91 Participants
n=390 Participants
|
96 Participants
n=393 Participants
|
187 Participants
n=783 Participants
|
|
Medical history
History of hyperlipidemia
|
56 Participants
n=390 Participants
|
57 Participants
n=393 Participants
|
113 Participants
n=783 Participants
|
|
Medical history
History of arthritis
|
19 Participants
n=390 Participants
|
25 Participants
n=393 Participants
|
44 Participants
n=783 Participants
|
|
Medical history
History of mood disorder
|
37 Participants
n=390 Participants
|
38 Participants
n=393 Participants
|
75 Participants
n=783 Participants
|
|
Medical history
History of anxiety
|
32 Participants
n=390 Participants
|
30 Participants
n=393 Participants
|
62 Participants
n=783 Participants
|
|
Medical history
History of mood disorder/anxiety
|
58 Participants
n=390 Participants
|
54 Participants
n=393 Participants
|
112 Participants
n=783 Participants
|
|
Medical history
Pregnant
|
0 Participants
n=390 Participants
|
1 Participants
n=393 Participants
|
1 Participants
n=783 Participants
|
|
Medical history
History of cardiometabolic disease
|
221 Participants
n=390 Participants
|
233 Participants
n=393 Participants
|
454 Participants
n=783 Participants
|
|
Baseline DLQI
|
12.3 units on a scale (0-30)
STANDARD_DEVIATION 7.2 • n=349 Participants • Missing data due to survey non-response
|
12.1 units on a scale (0-30)
STANDARD_DEVIATION 7.3 • n=344 Participants • Missing data due to survey non-response
|
12.2 units on a scale (0-30)
STANDARD_DEVIATION 7.2 • n=693 Participants • Missing data due to survey non-response
|
|
Baseline PGA
|
2.7 units on a scale
STANDARD_DEVIATION 0.8 • n=390 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.8 • n=393 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.8 • n=783 Participants
|
|
BSA
|
12.4 percentage
STANDARD_DEVIATION 15.3 • n=390 Participants
|
12.6 percentage
STANDARD_DEVIATION 16.1 • n=393 Participants
|
12.5 percentage
STANDARD_DEVIATION 15.7 • n=783 Participants
|
|
Age at psoriasis diagnosis
|
32.4 years
STANDARD_DEVIATION 17.5 • n=390 Participants
|
32.0 years
STANDARD_DEVIATION 18.8 • n=393 Participants
|
32.2 years
STANDARD_DEVIATION 18.2 • n=783 Participants
|
|
Psoriasis duration
|
15.4 years
STANDARD_DEVIATION 14.6 • n=390 Participants
|
16.2 years
STANDARD_DEVIATION 15.0 • n=393 Participants
|
15.8 years
STANDARD_DEVIATION 14.8 • n=783 Participants
|
|
Treatment history
Biologics
|
84 Participants
n=390 Participants
|
83 Participants
n=393 Participants
|
167 Participants
n=783 Participants
|
|
Treatment history
Non-biological systemic therapy
|
110 Participants
n=390 Participants
|
121 Participants
n=393 Participants
|
231 Participants
n=783 Participants
|
|
Treatment history
Biologics or non-biological systemic therapy
|
155 Participants
n=390 Participants
|
157 Participants
n=393 Participants
|
312 Participants
n=783 Participants
|
|
Treatment history
Phototherapy
|
165 Participants
n=390 Participants
|
172 Participants
n=393 Participants
|
337 Participants
n=783 Participants
|
|
Current treatment
Biologics
|
30 Participants
n=390 Participants
|
25 Participants
n=393 Participants
|
55 Participants
n=783 Participants
|
|
Current treatment
Non-biological systemic therapy
|
24 Participants
n=390 Participants
|
21 Participants
n=393 Participants
|
45 Participants
n=783 Participants
|
|
Current treatment
Biologics or non-biological systemic therapy
|
49 Participants
n=390 Participants
|
44 Participants
n=393 Participants
|
93 Participants
n=783 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: The outcome measures were analyzed by skin phototype strata in addition to total subjects
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).
Outcome measures
| Measure |
Home Based Phototherapy
n=393 Participants
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
|
Office Based Phototherapy
n=390 Participants
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
|
|---|---|---|
|
Physician Global Assessment (PGA) Score of Clear/Almost Clear
Phototype V/VI
|
14 Participants
|
6 Participants
|
|
Physician Global Assessment (PGA) Score of Clear/Almost Clear
All phototypes
|
129 Participants
|
100 Participants
|
|
Physician Global Assessment (PGA) Score of Clear/Almost Clear
Phototype I/II
|
58 Participants
|
47 Participants
|
|
Physician Global Assessment (PGA) Score of Clear/Almost Clear
Phototype III/IV
|
57 Participants
|
47 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: The outcome measures were analyzed by skin phototype strata in addition to total subjects
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
Outcome measures
| Measure |
Home Based Phototherapy
n=393 Participants
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
|
Office Based Phototherapy
n=390 Participants
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
|
|---|---|---|
|
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
All phototypes
|
206 Participants
|
131 Participants
|
|
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
Phototype I/II
|
108 Participants
|
65 Participants
|
|
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
Phototype III/IV
|
81 Participants
|
56 Participants
|
|
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
Phototype V/VI
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
patient or site reported phototherapy dosing
Outcome measures
| Measure |
Home Based Phototherapy
n=309 Participants
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
|
Office Based Phototherapy
n=232 Participants
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
|
|---|---|---|
|
Total Number of Phototherapy Treatments Received
All phototypes
|
26.82 treatments
Standard Deviation 10.63
|
17.95 treatments
Standard Deviation 8.83
|
|
Total Number of Phototherapy Treatments Received
Phototype I/II
|
28.24 treatments
Standard Deviation 9.57
|
18.86 treatments
Standard Deviation 8.99
|
|
Total Number of Phototherapy Treatments Received
Phototype III/IV
|
26.20 treatments
Standard Deviation 11.40
|
17.72 treatments
Standard Deviation 8.49
|
|
Total Number of Phototherapy Treatments Received
Phototype V/VI
|
21.78 treatments
Standard Deviation 11.07
|
14.96 treatments
Standard Deviation 9.15
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit.
Outcome measures
| Measure |
Home Based Phototherapy
n=309 Participants
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
|
Office Based Phototherapy
n=232 Participants
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
|
|---|---|---|
|
Cumulative Dose of Phototherapy Received
All phototypes
|
31.43 J/cm^2
Standard Deviation 29.55
|
17.27 J/cm^2
Standard Deviation 16.09
|
|
Cumulative Dose of Phototherapy Received
Phototype I/II
|
26.51 J/cm^2
Standard Deviation 20.94
|
15.04 J/cm^2
Standard Deviation 13.19
|
|
Cumulative Dose of Phototherapy Received
Phototype III/IV
|
32.80 J/cm^2
Standard Deviation 27.64
|
18.93 J/cm^2
Standard Deviation 16.79
|
|
Cumulative Dose of Phototherapy Received
Phototype V/VI
|
52.73 J/cm^2
Standard Deviation 58.29
|
19.90 J/cm^2
Standard Deviation 22.86
|
SECONDARY outcome
Timeframe: week 12 and week 24 after randomizationPopulation: The outcome measures were analyzed by skin phototype strata in addition to total subjects
Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication
Outcome measures
| Measure |
Home Based Phototherapy
n=325 Participants
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
|
Office Based Phototherapy
n=269 Participants
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
|
|---|---|---|
|
Concomitant Topical Psoriasis Treatment
All phototypes
|
3.06 days per week
Standard Deviation 2.80
|
3.92 days per week
Standard Deviation 2.91
|
|
Concomitant Topical Psoriasis Treatment
Phototype I/II
|
2.77 days per week
Standard Deviation 2.67
|
3.61 days per week
Standard Deviation 2.91
|
|
Concomitant Topical Psoriasis Treatment
Phototype III/IV
|
3.13 days per week
Standard Deviation 2.88
|
4.02 days per week
Standard Deviation 2.85
|
|
Concomitant Topical Psoriasis Treatment
Phototype V/VI
|
4.23 days per week
Standard Deviation 2.88
|
4.65 days per week
Standard Deviation 3.06
|
|
Concomitant Topical Psoriasis Treatment
All phototypes (week 24)
|
3.34 days per week
Standard Deviation 2.81
|
3.59 days per week
Standard Deviation 2.74
|
|
Concomitant Topical Psoriasis Treatment
Phototype I/II (week 24)
|
3.34 days per week
Standard Deviation 2.71
|
3.46 days per week
Standard Deviation 2.67
|
|
Concomitant Topical Psoriasis Treatment
Phototype III/IV (week 24)
|
3.21 days per week
Standard Deviation 2.88
|
3.74 days per week
Standard Deviation 2.78
|
|
Concomitant Topical Psoriasis Treatment
Phototype V/VI (week 24)
|
3.94 days per week
Standard Deviation 3.21
|
3.50 days per week
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: week 12 and week 24 after randomizationPopulation: 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.
Outcome measures
| Measure |
Home Based Phototherapy
n=339 Participants
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
|
Office Based Phototherapy
n=317 Participants
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
|
|---|---|---|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
All phototypes - Initiation
|
9 Participants
|
16 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype I/II - Initiation
|
2 Participants
|
4 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype III/IV - Initiation
|
6 Participants
|
10 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype V/VI - Initiation
|
1 Participants
|
2 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
All phototypes - Discontinuation
|
9 Participants
|
8 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype I/II - Discontinuation
|
3 Participants
|
2 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype III/IV - Discontinuation
|
6 Participants
|
5 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype V/VI - Discontinuation
|
0 Participants
|
1 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
All phototypes - Initiation (Week 24)
|
28 Participants
|
31 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype I/II - Initiation (Week 24)
|
10 Participants
|
9 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype III/IV - Initiation (Week 24)
|
14 Participants
|
17 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype V/VI - Initiation (Week 24)
|
4 Participants
|
5 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
All phototypes - Discontinuation (Week 24)
|
9 Participants
|
8 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype I/II - Discontinuation (Week 24)
|
3 Participants
|
2 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype III/IV - Discontinuation (Week 24)
|
6 Participants
|
5 Participants
|
|
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Phototype V/VI - Discontinuation (Week 24)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
patient reported survey
Outcome measures
| Measure |
Home Based Phototherapy
n=242 Participants
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
|
Office Based Phototherapy
n=190 Participants
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
|
|---|---|---|
|
Patient-reported Time Spent on Phototherapy Per Treatment
All phototypes
|
18.5 minutes
Standard Deviation 20.9
|
21.8 minutes
Standard Deviation 18.2
|
|
Patient-reported Time Spent on Phototherapy Per Treatment
Phototype I/II
|
16.32 minutes
Standard Deviation 14.59
|
21.58 minutes
Standard Deviation 20.45
|
|
Patient-reported Time Spent on Phototherapy Per Treatment
Phototype III/IV
|
18.11 minutes
Standard Deviation 21.14
|
22.03 minutes
Standard Deviation 16.77
|
|
Patient-reported Time Spent on Phototherapy Per Treatment
Phototype V/VI
|
32.48 minutes
Standard Deviation 38.13
|
22.06 minutes
Standard Deviation 15.09
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
patient reported survey for Office patients only
Outcome measures
| Measure |
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
|
Office Based Phototherapy
n=190 Participants
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
|
|---|---|---|
|
Patient Reported Costs Associated With Travel for Phototherapy Treatments
All phototypes
|
—
|
19.9 USD
Standard Deviation 61.6
|
|
Patient Reported Costs Associated With Travel for Phototherapy Treatments
Phototype I/II
|
—
|
18.06 USD
Standard Deviation 57.04
|
|
Patient Reported Costs Associated With Travel for Phototherapy Treatments
Phototype III/IV
|
—
|
23.46 USD
Standard Deviation 70.71
|
|
Patient Reported Costs Associated With Travel for Phototherapy Treatments
Phototype V/VI
|
—
|
9.22 USD
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
patient reported survey for Office patients only
Outcome measures
| Measure |
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
|
Office Based Phototherapy
n=190 Participants
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
|
|---|---|---|
|
Patient Reported Time Associated With Travel for Phototherapy Treatments
All phototypes
|
—
|
50.3 minutes
Standard Deviation 46.7
|
|
Patient Reported Time Associated With Travel for Phototherapy Treatments
Phototype I/II
|
—
|
53.19 minutes
Standard Deviation 50.05
|
|
Patient Reported Time Associated With Travel for Phototherapy Treatments
Phototype III/IV
|
—
|
49.82 minutes
Standard Deviation 47.43
|
|
Patient Reported Time Associated With Travel for Phototherapy Treatments
Phototype V/VI
|
—
|
39.72 minutes
Standard Deviation 20.47
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: The outcome measures were analyzed by skin phototype strata in addition to total subjects
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
Outcome measures
| Measure |
Home Based Phototherapy
n=393 Participants
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
|
Office Based Phototherapy
n=390 Participants
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
|
|---|---|---|
|
DLQI (0-1)
All phototypes
|
100 Participants
|
52 Participants
|
|
DLQI (0-1)
Phototype I/II
|
56 Participants
|
25 Participants
|
|
DLQI (0-1)
Phototype III/IV
|
34 Participants
|
26 Participants
|
|
DLQI (0-1)
Phototype V/VI
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
A difference of 4 was determined to be the MCID
Outcome measures
| Measure |
Home Based Phototherapy
n=276 Participants
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
|
Office Based Phototherapy
n=233 Participants
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
|
|---|---|---|
|
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
All phototypes
|
188 Participants
|
130 Participants
|
|
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
Phototype I/II
|
98 Participants
|
59 Participants
|
|
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
Phototype III/IV
|
74 Participants
|
56 Participants
|
|
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
Phototype V/VI
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
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.
Outcome measures
| Measure |
Home Based Phototherapy
n=255 Participants
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
|
Office Based Phototherapy
n=217 Participants
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
|
|---|---|---|
|
Physician Global Assessment Times Body Surface Area (PGAxBSA)
All phototypes
|
-23.26 units on a scale
Standard Deviation 47.16
|
-14.85 units on a scale
Standard Deviation 37.75
|
|
Physician Global Assessment Times Body Surface Area (PGAxBSA)
Phototype I/II
|
-28.04 units on a scale
Standard Deviation 55.64
|
-17.37 units on a scale
Standard Deviation 33.85
|
|
Physician Global Assessment Times Body Surface Area (PGAxBSA)
Phototype III/IV
|
-20.06 units on a scale
Standard Deviation 37.04
|
-14.76 units on a scale
Standard Deviation 38.78
|
|
Physician Global Assessment Times Body Surface Area (PGAxBSA)
Phototype V/VI
|
-14.94 units on a scale
Standard Deviation 44.72
|
-6.11 units on a scale
Standard Deviation 45.94
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12
Outcome measures
| Measure |
Home Based Phototherapy
n=255 Participants
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
|
Office Based Phototherapy
n=217 Participants
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
|
|---|---|---|
|
PGA x BSA 75%
All phototypes
|
140 Participants
|
94 Participants
|
|
PGA x BSA 75%
Phototype I/II
|
71 Participants
|
40 Participants
|
|
PGA x BSA 75%
Phototype III/IV
|
59 Participants
|
47 Participants
|
|
PGA x BSA 75%
Phototype V/VI
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12
Outcome measures
| Measure |
Home Based Phototherapy
n=255 Participants
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
|
Office Based Phototherapy
n=217 Participants
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
|
|---|---|---|
|
PGA x BSA 90%
All phototypes
|
101 Participants
|
68 Participants
|
|
PGA x BSA 90%
Phototype I/II
|
50 Participants
|
34 Participants
|
|
PGA x BSA 90%
Phototype III/IV
|
43 Participants
|
30 Participants
|
|
PGA x BSA 90%
Phototype V/VI
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 weeks after randomizationPopulation: 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.
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.
Outcome measures
| Measure |
Home Based Phototherapy
n=177 Participants
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
|
Office Based Phototherapy
n=96 Participants
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
|
|---|---|---|
|
Duration of Treatment Response During Observation Period
All phototypes
|
77.32 days
Standard Deviation 16.95
|
74.24 days
Standard Deviation 19.02
|
|
Duration of Treatment Response During Observation Period
Phototype I/II
|
75.96 days
Standard Deviation 18.16
|
76.37 days
Standard Deviation 16.24
|
|
Duration of Treatment Response During Observation Period
Phototype III/IV
|
78.76 days
Standard Deviation 15.39
|
71.17 days
Standard Deviation 22.23
|
|
Duration of Treatment Response During Observation Period
Phototype V/VI
|
79.0 days
Standard Deviation 16.64
|
73.5 days
Standard Deviation 22.39
|
SECONDARY outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
80% of assigned treatments is defined as 24 total treatments. Patients must have at least one treatment to be included.
Outcome measures
| Measure |
Home Based Phototherapy
n=309 Participants
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
|
Office Based Phototherapy
n=232 Participants
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
|
|---|---|---|
|
Patients Receiving at Least 80% of Treatments
All phototypes
|
202 Participants
|
62 Participants
|
|
Patients Receiving at Least 80% of Treatments
Phototype I/II
|
109 Participants
|
34 Participants
|
|
Patients Receiving at Least 80% of Treatments
Phototype III/IV
|
82 Participants
|
22 Participants
|
|
Patients Receiving at Least 80% of Treatments
Phototype V/VI
|
11 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: 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.
Burns lasting 48 hours or more
Outcome measures
| Measure |
Home Based Phototherapy
n=309 Participants
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
|
Office Based Phototherapy
n=232 Participants
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
|
|---|---|---|
|
Safety Analysis of Skin Related Events
All phototypes
|
165 Participants
|
22 Participants
|
|
Safety Analysis of Skin Related Events
Phototype I/II
|
77 Participants
|
11 Participants
|
|
Safety Analysis of Skin Related Events
Phototype III/IV
|
76 Participants
|
9 Participants
|
|
Safety Analysis of Skin Related Events
Phototype V/VI
|
12 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
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).
Outcome measures
| Measure |
Home Based Phototherapy
n=202 Participants
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
|
Office Based Phototherapy
n=62 Participants
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
|
|---|---|---|
|
Physician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)
All phototypes
|
95 Participants
|
32 Participants
|
|
Physician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)
Phototype I/II
|
47 Participants
|
17 Participants
|
|
Physician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)
Phototype III/IV
|
42 Participants
|
14 Participants
|
|
Physician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)
Phototype V/VI
|
6 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapyPopulation: 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.
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).
Outcome measures
| Measure |
Home Based Phototherapy
n=202 Participants
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
|
Office Based Phototherapy
n=62 Participants
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
|
|---|---|---|
|
Impact of Dermatological Disease on Quality of Life ("As Treated" Analysis)
All phototypes
|
140 Participants
|
39 Participants
|
|
Impact of Dermatological Disease on Quality of Life ("As Treated" Analysis)
Phototype I/II
|
79 Participants
|
22 Participants
|
|
Impact of Dermatological Disease on Quality of Life ("As Treated" Analysis)
Phototype III/IV
|
53 Participants
|
14 Participants
|
|
Impact of Dermatological Disease on Quality of Life ("As Treated" Analysis)
Phototype V/VI
|
8 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Week 12 to Week 24Population: The number analyzed per time point differ due to missing DLQI response
Number of participants that had a DLQI \<= 5 at week 16, week 20, and week 24
Outcome measures
| Measure |
Home Based Phototherapy
n=233 Participants
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
|
Office Based Phototherapy
n=169 Participants
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
|
|---|---|---|
|
Dichotomized DLQI Beyond Week 12
Week 16
|
150 Participants
|
90 Participants
|
|
Dichotomized DLQI Beyond Week 12
Week 20
|
118 Participants
|
88 Participants
|
|
Dichotomized DLQI Beyond Week 12
Week 24
|
139 Participants
|
105 Participants
|
Adverse Events
Office Based Phototherapy
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Home Based Phototherapy
Serious events: 3 serious events
Other events: 165 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Office Based Phototherapy
n=390 participants at risk
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
|
Home Based Phototherapy
n=393 participants at risk
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
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.51%
2/390 • Number of events 2 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
0.00%
0/393 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
|
Infections and infestations
Hospitalization for infected wounds
|
0.26%
1/390 • Number of events 1 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
0.00%
0/393 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
|
General disorders
Hospitalization for substance abuse treatment
|
0.00%
0/390 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
0.25%
1/393 • Number of events 1 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
|
Nervous system disorders
Severe neuropathy
|
0.00%
0/390 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
0.25%
1/393 • Number of events 1 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
|
General disorders
Hospitalization for blood pressure
|
0.00%
0/390 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
0.25%
1/393 • Number of events 1 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
|
General disorders
Seen in ER for chest pain
|
0.26%
1/390 • Number of events 1 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
0.00%
0/393 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
|
Infections and infestations
Death (Covid-19 related)
|
0.00%
0/390 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
0.25%
1/393 • Number of events 1 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
|
General disorders
Malnutrition resulting in hospitalization
|
0.00%
0/390 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
0.25%
1/393 • Number of events 1 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
Other adverse events
| Measure |
Office Based Phototherapy
n=390 participants at risk
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
|
Home Based Phototherapy
n=393 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Burns from phototherapy treatment
|
5.6%
22/390 • Number of events 46 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
42.0%
165/393 • Number of events 466 • Adverse events were assessed for up to 24 weeks from beginning of study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place