Light Treatment Effectiveness (LITE) Study
Status: | Recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 3/24/2019 |
Start Date: | March 1, 2019 |
End Date: | October 31, 2022 |
Contact: | Suzette Baez Vanderbeek, MPH |
Email: | suzette.baezvanderbeek@uphs.upenn.edu |
Phone: | 215-662-3514 |
A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis
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
weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of
psoriasis
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.
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.
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.
We found this trial at
4
sites
201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Kristina Callis Duffin, MD
Phone: 801-213-0375
University of Utah Research is a major component in the life of the U benefiting...
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3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Noori Kim, MD
Phone: 410-502-7546
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: April Armstrong, MD, MPH
Phone: 714-931-1440
University of Southern California The University of Southern California is one of the world’s leading...
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Buffalo, New York 14221
Principal Investigator: Robert E. Kalb, MD
Phone: 716-630-1457
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