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

March 25, 2010
March 6, 2012
January 2010
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01094717 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis
A Comparison of Treatment of Psoriasis With Acitretin or Tazarotene Gel 0.1% and Active or Sham Treatments With the 308 nm Excimer Laser

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
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: acitretin and excimer
    Intervention: Device: excimer vs sham excimer
  • Experimental: tazarotene and excimer
    Intervention: Device: excimer vs sham excimer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
October 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01094717
IRB_00031865
No
Kristina Callis, University of Utah
University of Utah
Not Provided
Principal Investigator: Kristina C Duffin, MD University of Utah
University of Utah
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP