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Trial record 23 of 51 for:    tazarotene

Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

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ClinicalTrials.gov Identifier: NCT01094717
Recruitment Status : Terminated (lack of efficacy and lack of funding)
First Posted : March 29, 2010
Results First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Kristina Callis, University of Utah

Brief 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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Acitretin 25Mg Oral Capsule Device: Excimer laser Drug: Tazarotene 0.1% Gel,Top Device: Sham excimer laser Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Excimer laser active and comparator were delivered the same way by a non-blinded person who applies a cap to the laser head to block UV rays for a sham administration. The masking was done by blindfolding the patients so they could not see which side was treated with active or sham laser. The outcomes assessor did their assessment in a separate room and access restricted to the randomization assignments.
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
Study Start Date : January 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: acitretin and active excimer laser
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.
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.

Experimental: acitretin and sham excimer laser
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.
Drug: Acitretin 25Mg Oral Capsule
Acitretin 25 mg oral daily for 12 weeks

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).

Experimental: tazarotene and active excimer laser
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.
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.

Experimental: tazarotene and sham excimer laser
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.
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).




Primary Outcome Measures :
  1. Change in the NPF Psoriasis Score of Plaques [ Time Frame: week 8 ]
    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)]


Secondary Outcome Measures :
  1. Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12. [ Time Frame: 8 weeks ]
    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].

  2. Number of Participants With Adverse Events [ Time Frame: 12 weeks ]
    We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094717


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

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Responsible Party: Kristina Callis, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01094717     History of Changes
Other Study ID Numbers: IRB_00031865
First Posted: March 29, 2010    Key Record Dates
Results First Posted: June 26, 2019
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kristina Callis, University of Utah:
psoriasis
excimer
acitretin
tazarotene
Additional relevant MeSH terms:
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Tazarotene
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Nicotinic Acids
Acitretin
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs