| 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). | The outcome measures were analyzed by skin phototype strata in addition to total subjects | Posted | | Count of Participants | | Participants | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
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| All phototypes | - ParticipantsOG000390
- ParticipantsOG001393
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Overall analysis including all skin phototypes | Marginal standardization | Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates | <0.001 | P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as <0.001. | Risk Difference (RD) | 7.2 | | | 2-Sided | 95 | 0.8 | 13.5 | | | | | Non-Inferiority | Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. |
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| 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 | The outcome measures were analyzed by skin phototype strata in addition to total subjects | Posted | | Count of Participants | | Participants | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Total Number of Phototherapy Treatments Received | patient or site reported phototherapy dosing | 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. | Posted | | Mean | Standard Deviation | treatments | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Cumulative Dose of Phototherapy Received | Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit. | 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. | Posted | | Mean | Standard Deviation | J/cm^2 | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Concomitant Topical Psoriasis Treatment | Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication | The outcome measures were analyzed by skin phototype strata in addition to total subjects | Posted | | Mean | Standard Deviation | days per week | | week 12 and week 24 after randomization | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments | | 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. | Posted | | Count of Participants | | Participants | | week 12 and week 24 after randomization | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Patient-reported Time Spent on Phototherapy Per Treatment | | 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. | Posted | | Mean | Standard Deviation | minutes | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Patient Reported Costs Associated With Travel for Phototherapy Treatments | patient reported survey for Office patients only | 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. | Posted | | Mean | Standard Deviation | USD | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| Secondary | Patient Reported Time Associated With Travel for Phototherapy Treatments | patient reported survey for Office patients only | 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. | Posted | | Mean | Standard Deviation | minutes | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 |
| |
| 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 | The outcome measures were analyzed by skin phototype strata in addition to total subjects | Posted | | Count of Participants | | Participants | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI | A difference of 4 was determined to be the MCID | 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. | Posted | | Count of Participants | | Participants | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Home Based Phototherapy | |
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| Secondary | PGA x BSA 75% | Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12 | 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. | Posted | | Count of Participants | | Participants | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | PGA x BSA 90% | Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12 | 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. | Posted | | Count of Participants | | Participants | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | days | | 24 weeks after randomization | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Other Pre-specified | Safety Analysis of Skin Related Events | Burns lasting 48 hours or more | 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. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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). | 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. | Posted | | Count of Participants | | Participants | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| 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). | 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. | Posted | | Count of Participants | | Participants | | 12 weeks after randomization or earlier at discontinuation of phototherapy | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Other Pre-specified | Dichotomized DLQI Beyond Week 12 | Number of participants that had a DLQI <= 5 at week 16, week 20, and week 24 | The number analyzed per time point differ due to missing DLQI response | Posted | | Count of Participants | | Participants | | From Week 12 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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