An interventional study of 308 nm excimer laser and Sham laser in Nail Psoriasis, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-18.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
Psoriasis is a common skin disease, which affects 2-3% of the population. Up to two third of patients with psoriasis develop nail changes. These visible changes can be painful and disabling and are associated with social stigma. Most topical treatments are only partially effective. Systemic treatments can have serious side effects. Excimer laser is a form of targeted ultraviolet light therapy that has been successfully used to treat isolated psoriatic plaques on difficult to treat areas such as scalp or palms. The purpose of this study is to investigate efficacy of excimer laser for treatment of fingernail psoriasis. Sixteen patients with stable fairly symmetric fingernail psoriasis will be enrolled. After obtaining informed consent, an investigator will evaluate the severity of nail psoriasis in each hand using an objective score, called Modified Nail Psoriasis Severity Index (mNAPSI). In a random fashion, one hand will be treated with excimer laser and the other hand will receive sham treatment. During the treatments, patients will wear protective eyewear that does not permit them to see which hand receives active treatment and which hand receives sham treatment. Patients will be treated twice a week for 8 weeks. At weeks 8, 12, and16 the investigator who is blinded to the treatment assignments will re-evaluate the fingernails using mNAPSI score. Mean change from baseline mNAPSI score at weeks 8, 12, and 16 in hands treated with excimer compared to hands treated with sham will be measured. We will also measure patient's assessment of severity of nail disease and the pain or any adverse events associated with laser treatments. Given the slow growth rate of fingernails, the final evaluations will be performed at week 16. In summary, this is the first controlled study to evaluate efficacy of excimer laser in fingernail psoriasis. If found to be effective, excimer laser could be used as a safe, locally administered treatment for recalcitrant nail psoriasis.
1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.
This study's enrollment of 8 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →University of Utah is the lead sponsor of 991 studies on the registry; 177 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 64 (58%) have results posted.
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Exclusion criteria:
308 nm excimer laser treatment: treatment with the laser by a dose protocol with increasing output.
Device: 308 nm excimer laser
Sham 308 nm excimer laser treatment: laser dose was administered with a cap that blocks all active UV passing through the device, therefore is a placebo, but because the procedure is the same, maintains a blind.
Device: Sham laser
Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
Sham laser treatment to the control side biweekly for a total of 8 weeks.
Modified NAPSI Score (Nail Psoriasis Severity Index)
This is an instrument that scores nail psoriasis severity. Severity for each nail is measured on a scale of 0-13, where crumbling, pitting, onycholysis and oil spots together are each graded 0-3, and other features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in lunula) are scored 0 (absent) or 1 (present). Higher score indicates more severe nail psoriasis with 13 being the most severe and 0 being no nail disease present.
Time frame: at 16 weeks
Patient Assessment of Nail Psoriasis Activity
this is a subjective patient reported scale, 0-100, where 100 is the most severe global assessment of the patient's nail psoriasis, and 0 is clear (no nail disease present).
Time frame: at 16 weeks
| Milestone | All Study Participants |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
This is an instrument that scores nail psoriasis severity. Severity for each nail is measured on a scale of 0-13, where crumbling, pitting, onycholysis and oil spots together are each graded 0-3, and other features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in lunula) are scored 0 (absent) or 1 (present). Higher score indicates more severe nail psoriasis with 13 being the most severe and 0 being no nail disease present.
| units on a scale | Active | Sham |
|---|---|---|
| Modified NAPSI Score (Nail Psoriasis Severity Index) | 6.3 ± 1.8 | 6.0 ± 1.3 |
this is a subjective patient reported scale, 0-100, where 100 is the most severe global assessment of the patient's nail psoriasis, and 0 is clear (no nail disease present).
| units on a scale | Active | Sham |
|---|---|---|
| Patient Assessment of Nail Psoriasis Activity | 58.6 ± 33.0 | 55.4 ± 24.3 |
Collected over Adverse event data were collected over 16 weeks (entire time of participation for each subject from screening to termination.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Sham | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 45 (19 to 73) |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 1 |
| Male | 7 |
The record gives a start of Jan 2014, a primary completion of Dec 2014 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2019, 4 years 8 months after primary completion.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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