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Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

This study has been terminated.
(lack of efficacy and lack of funding)
Sponsor:
Information provided by (Responsible Party):
Kristina Callis, University of Utah
ClinicalTrials.gov Identifier:
NCT01094717
First received: March 25, 2010
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Psoriasis
Device: excimer vs sham excimer

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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • change in the NPF psoriasis score of plaques with the assigned treatment, excimer laser or sham treatment. [ Time Frame: week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Amount of time measured in days 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.

  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    number of excimer light treatments (ELTs) 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites


Enrollment: 13
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acitretin and excimer Device: excimer vs sham excimer
half of lesions will be treated with excimer laser; half of lesions will be treated with sham excimer (opaque cover on the laser device)
Experimental: tazarotene and excimer Device: excimer vs sham excimer
half of lesions will be treated with excimer laser; half of lesions will be treated with sham excimer (opaque cover on the laser device)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094717

Locations
United States, Utah
University of Utah Department of Dermatology
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Kristina C Duffin, MD University of Utah
  More Information

Additional Information:
No publications provided

Responsible Party: Kristina Callis, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01094717     History of Changes
Other Study ID Numbers: IRB_00031865
Study First Received: March 25, 2010
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
psoriasis
excimer
acitretin
tazarotene

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Acitretin
Tazarotene
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014