Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

Not Applicable

Terminated

Conditions: Psoriasis

Interventions: Drug: Acitretin 25Mg Oral Capsule
Device: Excimer laser
Device: Sham excimer laser
Drug: Tazarotene 0.1% Gel,Top

Registration Number: NCT01094717

Lead Sponsor: University of Utah

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 13

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acitretin and active excimer laser	Excimer laser	patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to randomly assigned left or right side of body psoriasis lesions.
acitretin and sham excimer laser	Acitretin 25Mg Oral Capsule	Patients in this arm were treated with acitretin 25 mg daily and sham (placebo) excimer laser to randomly assigned left or right side of body psoriasis lesions.
acitretin and sham excimer laser	Sham excimer laser	Patients in this arm were treated with acitretin 25 mg daily and sham (placebo) excimer laser to randomly assigned left or right side of body psoriasis lesions.
tazarotene and active excimer laser	Excimer laser	patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and excimer (active) laser to randomly assigned left or right side of body psoriasis lesions.
tazarotene and sham excimer laser	Sham excimer laser	patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and sham excimer laser to randomly assigned left or right side of body psoriasis lesions.
acitretin and active excimer laser	Acitretin 25Mg Oral Capsule	patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to randomly assigned left or right side of body psoriasis lesions.
tazarotene and active excimer laser	Tazarotene 0.1% Gel,Top	patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and excimer (active) laser to randomly assigned left or right side of body psoriasis lesions.
tazarotene and sham excimer laser	Tazarotene 0.1% Gel,Top	patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and sham excimer laser to randomly assigned left or right side of body psoriasis lesions.

Primary Outcome Measures

Name	Time	Method
Change in the NPF Psoriasis Score of Plaques	week 8	mean % change in the National Psoriasis Foundation (NPF) psoriasis score of the target plaques \[higher percent change in NPF score is consistent with improvement, while higher absolute NPF score is consistent with worse disease, minimum score of 0 (no disease) and maximum score of 30 (worst disease)\]

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	12 weeks	We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites
Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.	8 weeks	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 \[15-point scale; maximum (most severe) score 15\].