An interventional study of Narrow band (310-312 nm) ultraviolet light B phototherapy and etanercept in Psoriasis, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-07.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
This is a single-center, open-label, pilot study. A total of 30 subjects (15 in each study arm) will be enrolled in this 6 month study to evaluate whether the addition of narrow band UVB (NB-UVB) phototherapy can enhance the efficacy of etanercept's maintenance dose, 50 mg once a week, in obese psoriasis patients.
In Phase I, all subjects will receive etanercept's induction dose, 50 mg twice a week, for a total of 12 weeks. In Phase II, all subjects will receive etanercept's maintenance dose, 50 mg once a week, during Weeks 12-24. Those subjects randomized to the treatment arm will receive NB-UVB phototherapy 3 times a week during Phase II. In order to ensure homogeneity between the NB-UVB arm and non-NB-UVB arm, subjects will be randomized according to their Body Mass Index (BMI). The Psoriasis Area Severity Index (PASI) score and Physician Global Assessment (PGA) will be calculated at each visit to determine the effectiveness of the etanercept and NB-UVB treatment during both phases of the study. The hypothesis is that the combination of NB-UVB phototherapy three times a week and etanercept maintenance dose (50 mg once a week) will enhance the efficacy of the maintenance dose alone in obese patients (BMI >30) with moderate to severe psoriasis.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
Drug: etanercept
Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff.
Procedure: Narrow band (310-312 nm) ultraviolet light B phototherapy · Drug: etanercept
Narrow band (310-312 nm) ultraviolet light B phototherapy 3 times a week during Weeks 12-24. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff
Also known as: nb-UVB, nbUVB, narrowband UVB
Etanercept is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
Also known as: Enbrel
Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below.
Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.
Time frame: Weeks 12-24
Dates of recruitment were July 2010 through June 2011. Recruitment was performed at the dermatologic medical clinic.
| Milestone | 1 (Etanercept Only) | 2 (Etanercept + Nb-UVB) |
|---|---|---|
| Started | 15 | 15 |
| Completed | 13 | 12 |
| Not completed | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Patient moved out of state | 1 | 0 |
Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.
| participants | 1 (Etanercept Only) | 2 (Etanercept + Nb-UVB) |
|---|---|---|
| Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below. | 6 | 6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 (Etanercept Only) | — | 0/15 (0%) | 0/15 (0%) |
| 2 (Etanercept + Nb-UVB) | — | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | 1 (Etanercept Only) | 2 (Etanercept + Nb-UVB) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 15 | 30 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | 1 (Etanercept Only) | 2 (Etanercept + Nb-UVB) | Total |
|---|---|---|---|
| Mean | 44.7 ± 1.8 | 43.8 ± 2.1 | 44.2 ± 1.9 |
| Sex: Female, Male(Participants) | 1 (Etanercept Only) | 2 (Etanercept + Nb-UVB) | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 12 | 13 | 25 |
| Region of Enrollment(participants) | 1 (Etanercept Only) | 2 (Etanercept + Nb-UVB) | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco