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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Acitretin 25Mg Oral Capsule
Device: Excimer laser
Drug: Tazarotene 0.1% Gel,Top
Device: Sham excimer laser
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acitretin and Excimer Tazarotene Gel and Excimer Laser
Hide Arm/Group Description Patients treated with acitretin 25 mg daily and active excimer laser to lesions on one half of the body (side assigned to active laser) and sham excimer laser (opaque cover on laser lens)to lesions on the other half of the body (side assigned to sham laser). patients in this group applied tazarotene 0.1% gel to all lesions and active excimer laser used to treat lesions on one half of the body (side assigned to active laser) and sham excimer laser (opaque cover applied over laser lens) used to treat lesions on the other half of the body (side assigned to sham laser).
Period Title: Overall Study
Started 3 10
Completed 3 10
Not Completed 0 0
Arm/Group Title Acitretin and Excimer Tazarotene and Excimer Total
Hide Arm/Group Description 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) 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) Total of all reporting groups
Overall Number of Baseline Participants 3 10 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 10 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  66.7%
8
  80.0%
10
  76.9%
>=65 years
1
  33.3%
2
  20.0%
3
  23.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 10 participants 13 participants
46.6  (19.4) 46.4  (17.2) 46.6  (16.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 10 participants 13 participants
Female
0
   0.0%
4
  40.0%
4
  30.8%
Male
3
 100.0%
6
  60.0%
9
  69.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 10 participants 13 participants
3
 100.0%
10
 100.0%
13
 100.0%
1.Primary Outcome
Title Change in the NPF Psoriasis Score of Plaques
Hide Description 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)]
Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acitretin and Excimer Acitretin and Sham (Placebo) Excimer Tazarotene Gel and Excimer Laser Tazarotene Gel and Sham (Placebo) Excimer
Hide Arm/Group Description:
patients received acitretin 25 mg daily and active excimer laser excimer twice weekly to lesions on one of half of the body that was assigned to active laser (left or right determined by randomization)
patients received acitretin 25 mg daily and sham (placebo) excimer twice weekly to lesions on one of half of the body that was assigned to sham (left or right determined by randomization)
patients received topical tazarotene gel 0.1% applied to all lesions daily, and active excimer laser excimer twice weekly to lesions on one of half of the body that was assigned to active laser (left or right determined by randomization)
patients receive tazarotene gel 0.1% applied daily to all lesions, and sham excimer twice weekly to lesions on one of half of the body that was assigned to sham (left or right determined by randomization)
Overall Number of Participants Analyzed 3 3 10 10
Mean (Standard Deviation)
Unit of Measure: percentage change
-64.0  (26.5) -52.1  (36.3) -32.7  (10.4) -26.9  (12.8)
2.Secondary Outcome
Title Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.
Hide Description 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].
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acitretin and Excimer Acitretin and Sham Excimer Laser Tazarotene and Excimer Tazarotene and Sham Excimer Laser
Hide Arm/Group Description:

patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to one side of the body and sham excimer (placebo) to the to the other side of body.

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)

patients treated with acitretin 25 mg and sham excimer laser.

patients enrolled in the tazarotene arm will be treated with topical tazarotene 0.1% gel and excimer (active) to one side of the body and sham excimer (placebo) to the to the other side of body.

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)

patients receiving tazotene gel 0.1% and sham excimer laser to half of body.
Overall Number of Participants Analyzed 3 3 10 10
Measure Type: Number
Unit of Measure: participants
1 0 0 0
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acitretin and Active Excimer Laser Acitretin and Sham Excimer Laser Tazarotene and Active Excimer Laser Tazarotene and Sham Excimer Laser
Hide Arm/Group 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.

excimer laser (active): Lesions on randomly assigned left or right side of body were treated with active excimer laser by an increasing dose level per a standard of care protocol.

Acitretin 25 MG: Patients assigned to this intervention took oral acitretin 25 mg daily.

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.

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

Acitretin 25 MG: Patients assigned to this intervention took oral acitretin 25 mg daily.

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.

excimer laser (active): Lesions on randomly assigned left or right side of body were treated with active excimer laser by an increasing dose level per a standard of care protocol.

Tazarotene 0.1% gel: Patients assigned to this intervention applied topical tazarotene gel 0.1% to all lesions daily.

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.

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

Acitretin 25 MG: Patients assigned to this intervention took oral acitretin 25 mg daily.

Overall Number of Participants Analyzed 3 3 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
any adverse event
2
  66.7%
2
  66.7%
4
  40.0%
4
  40.0%
severe adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acitretin and Excimer Tazarotene and Excimer
Hide Arm/Group Description 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) 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)
All-Cause Mortality
Acitretin and Excimer Tazarotene and Excimer
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acitretin and Excimer Tazarotene and Excimer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acitretin and Excimer Tazarotene and Excimer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      4/10 (40.00%)    
Endocrine disorders     
Elevated triglycerides  1/3 (33.33%)  1 0/10 (0.00%)  0
Eye disorders     
Dry eyes  1/3 (33.33%)  1 0/10 (0.00%)  0
General disorders     
Rigors  1/3 (33.33%)  1 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgia  1/3 (33.33%)  1 0/10 (0.00%)  0
Psychiatric disorders     
Irritability  1/3 (33.33%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry lips  2/3 (66.67%)  2 0/10 (0.00%)  0
Bump on figner  0/3 (0.00%)  0 1/10 (10.00%)  1
Eczema  0/3 (0.00%)  0 1/10 (10.00%)  1
Hyperpigmentation  0/3 (0.00%)  0 1/10 (10.00%)  1
Blister  0/3 (0.00%)  0 1/10 (10.00%)  3
Inflamed seborrheic keratosis  0/3 (0.00%)  0 1/10 (10.00%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristina Callis-Duffin
Organization: University of Utah, Derpartment of Dermatology
Phone: 8015816465
EMail: Kristina.Duffin@hsc.utah.edu
Layout table for additonal information
Responsible Party: Kristina Callis, University of Utah
ClinicalTrials.gov Identifier: NCT01094717     History of Changes
Other Study ID Numbers: IRB_00031865
First Submitted: March 25, 2010
First Posted: March 29, 2010
Results First Submitted: October 3, 2016
Results First Posted: June 26, 2019
Last Update Posted: June 26, 2019