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Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

Information source: University of Utah
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: excimer vs sham excimer (Device)

Phase: N/A

Status: Recruiting

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
Kristina C Duffin, MD, Principal Investigator, Affiliation: University of Utah

Overall contact:
Kristina C Duffin, MD, Phone: 801-581-6465, Email: kcallis@derm.med.utah.edu

Summary

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: change in the NPF psoriasis score of plaques with the assigned treatment, excimer laser or sham treatment.

Secondary outcome:

Time (days) 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.

number of excimer light treatments 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.

adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Kristina C Duffin, MD, Phone: 801-581-6465, Email: kcallis@derm.med.utah.edu

University of Utah Department of Dermatology, Salt Lake City, Utah 84132, United States; Recruiting
Kristina C Dufin, MD, Phone: 801-581-6465, Email: kcallis@derm.med.utah.edu
Kristina C Duffin, MD, Principal Investigator
Gerald G Krueger, MD, Sub-Investigator
Jackie Panko, MD, Sub-Investigator
Jamie Woodcock, MD, Sub-Investigator
Razieh Soltani-Arabshahi, MD, Sub-Investigator
Additional Information

link to U of Utah Dermatology Psoriasis Research website

Starting date: January 2010
Last updated: February 18, 2011

Page last updated: December 08, 2011

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