Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

NCT01094717 | Terminated Results

• 1 other identifier: IRB_00031865
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

psoriasis; excimer; acitretin; tazarotene

Outcome Measures

Primary Outcomes (1)

• Change in the NPF Psoriasis Score of Plaques

  mean % change in the National Psoriasis Foundation (NPF) psoriasis score of the target plaques \[higher percent change in NPF score is consistent with improvement, while higher absolute NPF score is consistent with worse disease, minimum score of 0 (no disease) and maximum score of 30 (worst disease)\]

  week 8

Secondary Outcomes (2)

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

  8 weeks

• Number of Participants With Adverse Events

  12 weeks

Study Arms (4)

acitretin and active excimer laser

EXPERIMENTAL

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; Device: Excimer laser

acitretin and sham excimer laser

EXPERIMENTAL

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; Device: Sham excimer laser

tazarotene and active excimer laser

EXPERIMENTAL

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; Drug: Tazarotene 0.1% Gel,Top

tazarotene and sham excimer laser

EXPERIMENTAL

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; Device: Sham excimer laser

Interventions

Acitretin 25Mg Oral Capsule DRUG

Acitretin 25 mg oral daily for 12 weeks

acitretin and active excimer laser; acitretin and sham excimer laser

Excimer laser DEVICE

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

acitretin and active excimer laser; tazarotene and active excimer laser

Tazarotene 0.1% Gel,Top DRUG

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

tazarotene and active excimer laser; tazarotene and sham excimer laser

Sham excimer laser DEVICE

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

acitretin and sham excimer laser; tazarotene and sham excimer laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Department of Dermatology

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Acitretin; Lasers, Excimer; tazarotene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Kristina Callis-Duffin
• Organization: University of Utah, Derpartment of Dermatology

Kristina.Duffin@hsc.utah.edu

8015816465

Study Officials

• Kristina C Duffin, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 29, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 26, 2019
• Results First Posted: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)