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Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

Primary Purpose

Psoriasis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acitretin 25Mg Oral Capsule

Excimer laser

Tazarotene 0.1% Gel,Top

Sham excimer laser

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, excimer, acitretin, tazarotene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Utah Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

acitretin and active excimer laser

acitretin and sham excimer laser

tazarotene and active excimer laser

tazarotene and sham excimer laser

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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)]

Secondary Outcome Measures

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].

Number of Participants With Adverse Events

We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites

Full Information

NCT ID

NCT01094717

First Posted

March 25, 2010

Last Updated

June 6, 2019

Sponsor

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT01094717

Brief Title

Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

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 Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

lack of efficacy and lack of funding

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

psoriasis, excimer, acitretin, tazarotene

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acitretin and active excimer laser

Arm Type

Experimental

Arm Description

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.

Arm Title

acitretin and sham excimer laser

Arm Type

Experimental

Arm Description

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.

Arm Title

tazarotene and active excimer laser

Arm Type

Experimental

Arm Description

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.

Arm Title

tazarotene and sham excimer laser

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Acitretin 25Mg Oral Capsule

Intervention Description

Acitretin 25 mg oral daily for 12 weeks

Intervention Type

Device

Intervention Name(s)

Excimer laser

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tazarotene 0.1% Gel,Top

Intervention Description

Topical tazarotene 0.1% gel was applied daily to active lesions.

Intervention Type

Device

Intervention Name(s)

Sham excimer laser

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the NPF Psoriasis Score of Plaques

Description

Time Frame

week 8

Secondary Outcome Measure Information:

Title

Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.

Description

Time Frame

8 weeks

Title

Number of Participants With Adverse Events

Description

We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristina C Duffin, MD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Utah Department of Dermatology

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

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