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Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis - NCT01094717-84132(Clinical Trial 596126)



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City:  Salt Lake City
State:  
UT
Zip Code: 84132
Conditions: Psoriasis
Purpose: 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 summary:
Criteria: Inclusion Criteria: - Must give written informed consent - Must be at least 18 years old - Must have been diagnosed with stable plaque type psoriasis covering between 1 and 5% BSA - NPF-PS ≥8 (based additive scores averaged over all lesions for erythema, scale, and thickness range of score = 0-5) - No systemic or phototherapy in the 4 wks prior to entering the study - No topical therapy other than emollients (no corticosteroids, vitamin D analogs, vitamin A analogs) in the 2 wks prior to entering the study - Women on tazarotene gel must not be pregnant nor planning to become pregnant during the study and must be on two forms of birth control - Subjects known to not tolerate oral acitretin at 25 mg/day and women of child-bearing potential may be enrolled and treated with topical tazarotene gel 0.1% Exclusion Criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment: - Unstable disease - Only treatable sites are in intertriginous areas or on face - Subjects unable to tolerate frequency of visits - NPF-PS severity score <8 additive score of erythema, scale, and thickness, averaged over all lesions - History of inability to tolerate topical tazarotene 0.1% gel and or acitretin 25 mg/day - Women of childbearing potential are excluded from the actretin arm of the study.
Study is available at: University of Utah Department of Dermatology
Salt Lake City, UT 84132
United States

Primary Contact:
Kristina C Dufin, MD
Email: kcallis@derm.med.utah.edu
Phone: 801-581-6465

Secondary Contact:
Kristina C Duffin, MD
Email: kcallis@derm.med.utah.edu
Phone: 801-581-6465
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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