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Completed

NCT Number: NCT03726489

Light Treatment Effectiveness (LITE) Study

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

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Key information

Conditions

Psoriasis Psoriatic Plaque Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Total Skin & Beauty Dermatology Center, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
  • Age 12 or older
  • 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
  • Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
  • 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
  • In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
  • New or established patient in the practice

Exclusion criteria

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

Treatment and study plan

Daavlin 7 series 3 panel narrow band phototherapy home units

Device

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

narrow band phototherapy clinic units

Device

Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure

Primary outcomes

  1. Physician Global Assessment (PGA) Score of Clear/Almost Clear

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    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).

  2. Impact of Dermatological Disease on Quality of Life (DLQI ≤5)

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    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

Secondary outcomes

  1. Total Number of Phototherapy Treatments Received

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    patient or site reported phototherapy dosing

  2. Cumulative Dose of Phototherapy Received

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit.

  3. Concomitant Topical Psoriasis Treatment

    Time frame: week 12 and week 24 after randomization

    Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication

  4. Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments

    Time frame: week 12 and week 24 after randomization

  5. Patient-reported Time Spent on Phototherapy Per Treatment

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    patient reported survey

  6. Patient Reported Costs Associated With Travel for Phototherapy Treatments

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    patient reported survey for Office patients only

  7. Patient Reported Time Associated With Travel for Phototherapy Treatments

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    patient reported survey for Office patients only

  8. DLQI (0-1)

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    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

  9. Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    A difference of 4 was determined to be the MCID

  10. Physician Global Assessment Times Body Surface Area (PGAxBSA)

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    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.

  11. PGA x BSA 75%

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12

  12. PGA x BSA 90%

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12

  13. Duration of Treatment Response During Observation Period

    Time frame: 24 weeks after randomization

    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.

  14. Patients Receiving at Least 80% of Treatments

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    80% of assigned treatments is defined as 24 total treatments. Patients must have at least one treatment to be included.

Other outcomes

  1. Safety Analysis of Skin Related Events

    Time frame: Week 12

    Burns lasting 48 hours or more

  2. Physician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    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).

  3. Impact of Dermatological Disease on Quality of Life ("As Treated" Analysis)

    Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy

    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).

  4. Dichotomized DLQI Beyond Week 12

    Time frame: From Week 12 to Week 24

    Number of participants that had a DLQI <= 5 at week 16, week 20, and week 24

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Psoriasis Foundation
  • Patient-Centered Outcomes Research Institute
  • University of Utah

Registry information

Official study title

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

Acronym: LITE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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