Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison of Treatment of Psoriasis With Acitretin or Tazarotene Gel 0.1% and Active or Sham Treatments With the 308 nm Excimer Laser

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Acitretin 25Mg Oral Capsule
* Device: Excimer laser
* Drug: Tazarotene 0.1% Gel,Top
* Device: Sham excimer laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acitretin and active excimer laser<br>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. | Drug: Acitretin 25Mg Oral Capsule<br>* Acitretin 25 mg oral daily for 12 weeks<br>Device: Excimer laser<br>* Lesions on randomly assigned left or right side of body were treated with 308nm excimer laser.<br>|
| Experimental: acitretin and sham excimer laser<br>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. | Drug: Acitretin 25Mg Oral Capsule<br>* Acitretin 25 mg oral daily for 12 weeks<br>Device: Sham excimer laser<br>* Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).<br>|
| Experimental: tazarotene and active excimer laser<br>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. | Device: Excimer laser<br>* Lesions on randomly assigned left or right side of body were treated with 308nm excimer laser.<br>Drug: Tazarotene 0.1% Gel,Top<br>* Topical tazarotene 0.1% gel was applied daily to active lesions.<br>|
| Experimental: tazarotene and sham excimer laser<br>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. | Drug: Tazarotene 0.1% Gel,Top<br>* Topical tazarotene 0.1% gel was applied daily to active lesions.<br>Device: Sham excimer laser<br>* Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)] | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]. | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, excimer, acitretin, tazarotene