Trial Outcomes & Findings for Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis (NCT NCT01094717)

Last Updated: 2019-06-26

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

week 8

Results posted on

2019-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Acitretin and Excimer 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).	Tazarotene Gel and Excimer 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).
Overall Study STARTED	3	10
Overall Study COMPLETED	3	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acitretin and Excimer n=3 Participants 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)	Tazarotene and Excimer n=10 Participants 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 n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=39 Participants	8 Participants n=41 Participants	10 Participants n=35 Participants
Age, Categorical >=65 years	1 Participants n=39 Participants	2 Participants n=41 Participants	3 Participants n=35 Participants
Age, Continuous	46.6 years STANDARD_DEVIATION 19.4 • n=39 Participants	46.4 years STANDARD_DEVIATION 17.2 • n=41 Participants	46.6 years STANDARD_DEVIATION 16.9 • n=35 Participants
Sex: Female, Male Female	0 Participants n=39 Participants	4 Participants n=41 Participants	4 Participants n=35 Participants
Sex: Female, Male Male	3 Participants n=39 Participants	6 Participants n=41 Participants	9 Participants n=35 Participants
Region of Enrollment United States	3 Participants n=39 Participants	10 Participants n=41 Participants	13 Participants n=35 Participants

PRIMARY outcome

Timeframe: week 8

Outcome measures

Outcome measures
Measure	Acitretin and Excimer n=3 Participants 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)	Acitretin and Sham (Placebo) Excimer n=3 Participants 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)	Tazarotene Gel and Excimer Laser n=10 Participants 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)	Tazarotene Gel and Sham (Placebo) Excimer n=10 Participants 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)
Change in the NPF Psoriasis Score of Plaques	-64.0 percentage change Standard Deviation 26.5	-52.1 percentage change Standard Deviation 36.3	-32.7 percentage change Standard Deviation 10.4	-26.9 percentage change Standard Deviation 12.8

SECONDARY outcome

Timeframe: 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 \[15-point scale; maximum (most severe) score 15\].

Outcome measures

Outcome measures
Measure	Acitretin and Excimer n=3 Participants 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)	Acitretin and Sham (Placebo) Excimer n=3 Participants 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)	Tazarotene Gel and Excimer Laser n=10 Participants 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)	Tazarotene Gel and Sham (Placebo) Excimer n=10 Participants 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)
Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Acitretin and Excimer n=3 Participants 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)	Acitretin and Sham (Placebo) Excimer n=3 Participants 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)	Tazarotene Gel and Excimer Laser n=10 Participants 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)	Tazarotene Gel and Sham (Placebo) Excimer n=10 Participants 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)
Number of Participants With Adverse Events any adverse event	2 Participants	2 Participants	4 Participants	4 Participants
Number of Participants With Adverse Events severe adverse events	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Acitretin and Excimer

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Tazarotene and Excimer

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acitretin and Excimer n=3 participants at risk 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)	Tazarotene and Excimer n=10 participants at risk 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)
Skin and subcutaneous tissue disorders Dry lips	66.7% 2/3 • Number of events 2	0.00% 0/10
Eye disorders Dry eyes	33.3% 1/3 • Number of events 1	0.00% 0/10
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1	0.00% 0/10
Psychiatric disorders Irritability	33.3% 1/3 • Number of events 1	0.00% 0/10
General disorders Rigors	33.3% 1/3 • Number of events 1	0.00% 0/10
Skin and subcutaneous tissue disorders Bump on figner	0.00% 0/3	10.0% 1/10 • Number of events 1
Endocrine disorders Elevated triglycerides	33.3% 1/3 • Number of events 1	0.00% 0/10
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3	10.0% 1/10 • Number of events 1
Skin and subcutaneous tissue disorders Hyperpigmentation	0.00% 0/3	10.0% 1/10 • Number of events 1
Skin and subcutaneous tissue disorders Blister	0.00% 0/3	10.0% 1/10 • Number of events 3
Skin and subcutaneous tissue disorders Inflamed seborrheic keratosis	0.00% 0/3	10.0% 1/10 • Number of events 1

Additional Information

Kristina Callis-Duffin

University of Utah, Derpartment of Dermatology

Phone: 8015816465

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place