An interventional study of Acitretin 25Mg Oral Capsule and Excimer laser in Psoriasis, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-26.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
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.
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 13 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
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
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
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
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
Acitretin 25 mg oral daily for 12 weeks
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.
Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).
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
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
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
| Milestone | Acitretin and Excimer | Tazarotene Gel and Excimer Laser |
|---|---|---|
| Started | 3 | 10 |
| Completed | 3 | 10 |
| Not completed | 0 | 0 |
mean % change in the National Psoriasis Foundation (NPF) psoriasis score of the target plaques \[higher percent change in NPF score is consistent with improvement, while higher absolute NPF score is consistent with worse disease, minimum score of 0 (no disease) and maximum score of 30 (worst disease)\]
| percentage change | Acitretin and Excimer | Acitretin and Sham (Placebo) Excimer | Tazarotene Gel and Excimer Laser | Tazarotene Gel and Sham (Placebo) Excimer |
|---|---|---|---|---|
| Change in the NPF Psoriasis Score of Plaques | -64.0 ± 26.5 | -52.1 ± 36.3 | -32.7 ± 10.4 | -26.9 ± 12.8 |
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 \[15-point scale; maximum (most severe) score 15\].
| participants | Acitretin and Excimer | Acitretin and Sham Excimer Laser | Tazarotene and Excimer | Tazarotene and Sham Excimer Laser |
|---|---|---|---|---|
| Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12. | 1 | 0 | 0 | 0 |
We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites
| Participants | Acitretin and Active Excimer Laser | Acitretin and Sham Excimer Laser | Tazarotene and Active Excimer Laser | Tazarotene and Sham Excimer Laser |
|---|---|---|---|---|
| any adverse event | 2 | 2 | 4 | 4 |
| severe adverse events | 0 | 0 | 0 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acitretin and Excimer | — | 0/3 (0%) | 2/3 (66.7%) |
| Tazarotene and Excimer | — | 0/10 (0%) | 4/10 (40%) |
| Event | Acitretin and Excimer | Tazarotene and Excimer |
|---|---|---|
| Dry lipsSkin and subcutaneous tissue disorders | 2/3 | 0/10 |
| Dry eyesEye disorders | 1/3 | 0/10 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/3 | 0/10 |
| IrritabilityPsychiatric disorders | 1/3 | 0/10 |
| RigorsGeneral disorders | 1/3 | 0/10 |
| Elevated triglyceridesEndocrine disorders | 1/3 | 0/10 |
| Bump on fignerSkin and subcutaneous tissue disorders | 0/3 | 1/10 |
| EczemaSkin and subcutaneous tissue disorders | 0/3 | 1/10 |
| HyperpigmentationSkin and subcutaneous tissue disorders | 0/3 | 1/10 |
| BlisterSkin and subcutaneous tissue disorders | 0/3 | 1/10 |
| Age, Categorical(Participants) | Acitretin and Excimer | Tazarotene and Excimer | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 8 | 10 |
| >=65 years | 1 | 2 | 3 |
| Age, Continuous(years) | Acitretin and Excimer | Tazarotene and Excimer | Total |
|---|---|---|---|
| Mean | 46.6 ± 19.4 | 46.4 ± 17.2 | 46.6 ± 16.9 |
| Sex: Female, Male(Participants) | Acitretin and Excimer | Tazarotene and Excimer | Total |
|---|---|---|---|
| Female | 0 | 4 | 4 |
| Male | 3 | 6 | 9 |
| Region of Enrollment(Participants) | Acitretin and Excimer | Tazarotene and Excimer | Total |
|---|---|---|---|
| United States | 3 | 10 | 13 |
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