N/A
Completed N=783
Light Treatment Effectiveness (LITE) Study
Psoriasis · Psoriatic Plaque
Source: ClinicalTrials.gov NCT03726489 ↗
Enrolled (actual)
783
Serious AEs
0.9%
Results posted
Sep 2024
Primary outcomePrimary: Physician Global Assessment (PGA) Score of Clear/Almost Clear — 100; 129; 47; 58 Participants — p=<0.001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician Global Assessment (PGA) Score of Clear/Almost Clear |
100; 129; 47; 58; 47; 57 | <0.001 sig |
| PRIMARY Impact of Dermatological Disease on Quality of Life (DLQI ≤5) |
131; 206; 65; 108; 56; 81 | <0.001 sig |
| SECONDARY Total Number of Phototherapy Treatments Received |
17.95; 26.82; 18.86; 28.24; 17.72; 26.20 | <0.0001 sig |
| SECONDARY Cumulative Dose of Phototherapy Received |
17.27; 31.43; 15.04; 26.51; 18.93; 32.80 | <0.0001 sig |
| SECONDARY Concomitant Topical Psoriasis Treatment |
3.92; 3.06; 3.61; 2.77; 4.02; 3.13 | 0.001 sig |
| SECONDARY Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments |
16; 9; 4; 2; 10; 6 | 0.1209 |
| SECONDARY Patient-reported Time Spent on Phototherapy Per Treatment |
21.8; 18.5; 21.58; 16.32; 22.03; 18.11 | 0.094 |
| SECONDARY Patient Reported Costs Associated With Travel for Phototherapy Treatments |
19.9; 18.06; 23.46; 9.22 | — |
| SECONDARY Patient Reported Time Associated With Travel for Phototherapy Treatments |
50.3; 53.19; 49.82; 39.72 | — |
| SECONDARY DLQI (0-1) |
52; 100; 25; 56; 26; 34 | <0.0001 sig |
| SECONDARY Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI |
130; 188; 59; 98; 56; 74 | 0.0065 sig |
| SECONDARY Physician Global Assessment Times Body Surface Area (PGAxBSA) |
-14.85; -23.26; -17.37; -28.04; -14.76; -20.06 | 0.048 sig |
| SECONDARY PGA x BSA 75% |
94; 140; 40; 71; 47; 59 | 0.0173 sig |
| SECONDARY PGA x BSA 90% |
68; 101; 34; 50; 30; 43 | 0.0853 |
| SECONDARY Duration of Treatment Response During Observation Period |
74.24; 77.32; 76.37; 75.96; 71.17; 78.76 | 0.175 |
| SECONDARY Patients Receiving at Least 80% of Treatments |
62; 202; 34; 109; 22; 82 | <0.0001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03726489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.