Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Tina Bhutani-Jacques

Description

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

Official Title

A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis

Details

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.

Keywords

Psoriasis Psoriatic Plaque Daavlin 7 series 3 panel narrow band phototherapy home units narrow band phototherapy clinic units Office Based Phototherapy Home Based Phototherapy

Eligibility

You can join if…

Open to people ages 12 years and up

  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:
  5. 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
  6. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
  7. New or established patient in the practice

You CAN'T join if...

  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:
  3. How to operate the phototherapy device
  4. How to follow the dosing protocol
  5. Requirement to wear protective eyewear and genital protection equipment
  6. Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
  7. Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
  8. Patients deemed unsafe to be treated with phototherapy:
  9. History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
  10. History of arsenic intake
  11. Unable to tolerate standing for required duration of treatment due to age or physical function
  12. History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
  13. Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pennsylvania
ID
NCT03726489
Study Type
Interventional
Last Updated