Clinical trial NCT01094717: Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis
Official title: A Comparison of Treatment of Psoriasis With Acitretin or Tazarotene Gel 0.1% and Active or Sham Treatments With the 308 nm Excimer Laser
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psoriasis
Keywords: psoriasis
excimer
acitretin
tazarotene
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Change in the NPF Psoriasis Score of Plaques
timeFrame: week 8
Secondary outcomes:
measure: Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.
timeFrame: 8 weeks
measure: Number of Participants With Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Department of Dermatology
state: Utah
Study officials:
affiliation: University of Utah
name: Kristina C Duffin, MD
role: PRINCIPAL_INVESTIGATOR
References: