Brief Summary
To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis
Brief Title
Light Treatment Effectiveness (LITE) Study
Detailed Description
The primary objective of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis. Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. This is a three year pragmatic, randomized, active comparator effectiveness study.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Psoriasis
Psoriatic Plaque
Eligibility Criteria
Inclusion Criteria:
1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
2. Age 12 or older
3. Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of \>1.0, and considered a candidate for phototherapy
4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
1. In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
5. New or established patient in the practice
Exclusion Criteria:
1. Patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints
2. Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:
1. How to operate the phototherapy device
2. How to follow the dosing protocol
3. Requirement to wear protective eyewear and genital protection equipment
3. Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
4. Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
5. Patients deemed unsafe to be treated with phototherapy:
1. History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
2. History of arsenic intake
3. Unable to tolerate standing for required duration of treatment due to age or physical function
4. History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
6. Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
2. Age 12 or older
3. Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of \>1.0, and considered a candidate for phototherapy
4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
1. In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
5. New or established patient in the practice
Exclusion Criteria:
1. Patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints
2. Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:
1. How to operate the phototherapy device
2. How to follow the dosing protocol
3. Requirement to wear protective eyewear and genital protection equipment
3. Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
4. Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
5. Patients deemed unsafe to be treated with phototherapy:
1. History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
2. History of arsenic intake
3. Unable to tolerate standing for required duration of treatment due to age or physical function
4. History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
6. Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
Inclusion Criteria
Inclusion Criteria:
1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
2. Age 12 or older
3. Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of \>1.0, and considered a candidate for phototherapy
4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
1. In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
5. New or established patient in the practice
1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
2. Age 12 or older
3. Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of \>1.0, and considered a candidate for phototherapy
4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
1. In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
5. New or established patient in the practice
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
12 Years
NCT Id
NCT03726489
Org Class
Other
Org Full Name
University of Pennsylvania
Org Study Id
831323
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis
Primary Outcomes
Outcome Description
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 Measure
Physician Global Assessment (PGA) Score of Clear/Almost Clear
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Description
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 Measure
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Secondary Ids
Secondary Id
PCS-1608-35830
Secondary Outcomes
Outcome Description
patient or site reported phototherapy dosing
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
Total Number of Phototherapy Treatments Received
Outcome Description
Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit.
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
Cumulative Dose of Phototherapy Received
Outcome Description
Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication
Outcome Time Frame
week 12 and week 24 after randomization
Outcome Measure
Concomitant Topical Psoriasis Treatment
Outcome Time Frame
week 12 and week 24 after randomization
Outcome Measure
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Outcome Description
patient reported survey
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
Patient-reported Time Spent on Phototherapy Per Treatment
Outcome Description
patient reported survey for Office patients only
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
Patient Reported Costs Associated With Travel for Phototherapy Treatments
Outcome Description
patient reported survey for Office patients only
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
Patient Reported Time Associated With Travel for Phototherapy Treatments
Outcome Description
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 Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
DLQI (0-1)
Outcome Description
A difference of 4 was determined to be the MCID
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
Outcome Description
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.
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 Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
Physician Global Assessment Times Body Surface Area (PGAxBSA)
Outcome Description
Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
PGA x BSA 75%
Outcome Description
Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
PGA x BSA 90%
Outcome Description
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 Time Frame
24 weeks after randomization
Outcome Measure
Duration of Treatment Response During Observation Period
Outcome Description
80% of assigned treatments is defined as 24 total treatments. Patients must have at least one treatment to be included.
Outcome Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Outcome Measure
Patients Receiving at Least 80% of Treatments
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741