This is a randomized, double-blind study of excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily for plaque psoriasis. The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD.
The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone. The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will be the comparison between the change in NPF score of plaques treated with excimer laser and those treated with sham treatment. The secondary objectives are to compare the number of excimer light treatments and time necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to combinations of the study treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
Acitretin 25 mg oral daily for 12 weeks
Lesions on randomly assigned left or right side of body were treated with 308nm excimer laser.
Topical tazarotene 0.1% gel was applied daily to active lesions.
University of Utah Department of Dermatology
Salt Lake City, Utah, United States
Change in the NPF Psoriasis Score of Plaques
mean % change in the National Psoriasis Foundation (NPF) psoriasis score of the target plaques \[higher percent change in NPF score is consistent with improvement, while higher absolute NPF score is consistent with worse disease, minimum score of 0 (no disease) and maximum score of 30 (worst disease)\]
Time frame: week 8
Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.
number of patients who achieved average lesion assessment score of 0 or 1 by the Target Plaque Sum Score (TPSS) for each arm/intervention. For the TPSS, the target plaque was assessed separately for induration, scaling, and erythema using a 6-point severity scale (0 = none and 5 = severe) and the scores were summed to produce the Target Plaque Sum Score \[15-point scale; maximum (most severe) score 15\].
Time frame: 8 weeks
Number of Participants With Adverse Events
We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites
Time frame: 12 weeks
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Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).