Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01094717
• Other study ID #: IRB_00031865
• Status: Terminated
• Phase: N/A
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Acitretin 25Mg Oral Capsule
Acitretin 25 mg oral daily for 12 weeks

Device:
• Excimer laser
Lesions on randomly assigned left or right side of body were treated with 308nm excimer laser.

Drug:
• Tazarotene 0.1% Gel,Top
Topical tazarotene 0.1% gel was applied daily to active lesions.

Device:
• Sham excimer laser
Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).

Locations

Country	Name	City	State
United States	University of Utah Department of Dermatology	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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