Psoriasis
Conditions
Keywords
psoriasis, excimer, acitretin, tazarotene
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.
Interventions
DRUGAcitretin 25Mg Oral Capsule
Acitretin 25 mg oral daily for 12 weeks
DEVICEExcimer laser
Lesions on randomly assigned left or right side of body were treated with 308nm excimer laser.
Topical tazarotene 0.1% gel was applied daily to active lesions.
DEVICESham excimer laser
Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the NPF Psoriasis Score of Plaques | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12. | 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 \[15-point scale; maximum (most severe) score 15\]. |
| Number of Participants With Adverse Events | 12 weeks | We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acitretin and Excimer 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) | 3 |
| Tazarotene and Excimer 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) | 10 |
| Total | 13 |
Baseline characteristics
| Characteristic | Tazarotene and Excimer | Acitretin and Excimer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 2 Participants | 10 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 17.2 | 46.6 years STANDARD_DEVIATION 19.4 | 46.6 years STANDARD_DEVIATION 16.9 |
| Region of Enrollment United States | 10 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Female | 4 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 3 | 4 / 10 |
| serious Total, serious adverse events | 0 / 3 | 0 / 10 |
Outcome results
Primary
Change in the NPF Psoriasis Score of Plaques
mean % change in the National Psoriasis Foundation (NPF) psoriasis score of the target plaques \[higher percent change in NPF score is consistent with improvement, while higher absolute NPF score is consistent with worse disease, minimum score of 0 (no disease) and maximum score of 30 (worst disease)\]
Time frame: week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acitretin and Excimer | Change in the NPF Psoriasis Score of Plaques | -64.0 percentage change | Standard Deviation 26.5 |
| Acitretin and Sham (Placebo) Excimer | Change in the NPF Psoriasis Score of Plaques | -52.1 percentage change | Standard Deviation 36.3 |
| Tazarotene Gel and Excimer Laser | Change in the NPF Psoriasis Score of Plaques | -32.7 percentage change | Standard Deviation 10.4 |
| Tazarotene Gel and Sham (Placebo) Excimer | Change in the NPF Psoriasis Score of Plaques | -26.9 percentage change | Standard Deviation 12.8 |
Secondary
Number of Participants With Adverse Events
We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Acitretin and Excimer | Number of Participants With Adverse Events | any adverse event | 2 Participants |
| Acitretin and Excimer | Number of Participants With Adverse Events | severe adverse events | 0 Participants |
| Acitretin and Sham (Placebo) Excimer | Number of Participants With Adverse Events | severe adverse events | 0 Participants |
| Acitretin and Sham (Placebo) Excimer | Number of Participants With Adverse Events | any adverse event | 2 Participants |
| Tazarotene Gel and Excimer Laser | Number of Participants With Adverse Events | any adverse event | 4 Participants |
| Tazarotene Gel and Excimer Laser | Number of Participants With Adverse Events | severe adverse events | 0 Participants |
| Tazarotene Gel and Sham (Placebo) Excimer | Number of Participants With Adverse Events | any adverse event | 4 Participants |
| Tazarotene Gel and Sham (Placebo) Excimer | Number of Participants With Adverse Events | severe adverse events | 0 Participants |
Secondary
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 \[15-point scale; maximum (most severe) score 15\].
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acitretin and Excimer | Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12. | 1 participants |
| Acitretin and Sham (Placebo) Excimer | Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12. | 0 participants |
| Tazarotene Gel and Excimer Laser | Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12. | 0 participants |
| Tazarotene Gel and Sham (Placebo) Excimer | Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12. | 0 participants |