Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

Utah System of Higher Education (USHE)

Status: Terminated

Conditions: Psoriasis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01094717

IRB_00031865

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 4 patient groups

acitretin and active excimer laser

Experimental group

Description:

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.

Treatment:

Drug: Acitretin 25Mg Oral Capsule

Device: Excimer laser

acitretin and sham excimer laser

Experimental group

Description:

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.

Treatment:

Device: Sham excimer laser

Drug: Acitretin 25Mg Oral Capsule

tazarotene and active excimer laser

Experimental group

Description:

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.

Treatment:

Drug: Tazarotene 0.1% Gel,Top

Device: Excimer laser

tazarotene and sham excimer laser

Experimental group

Description:

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.

Treatment:

Device: Sham excimer laser

Drug: Tazarotene 0.1% Gel,Top