308nm Excimer Laser for Treatment of Fingernail Psoriasis (NAPSI)
|ClinicalTrials.gov Identifier: NCT02168933|
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : August 20, 2019
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nail Psoriasis||Device: 308 nm excimer laser Device: Sham laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of 308 nm Excimer Laser for Treatment of Nail Psoriasis|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||January 2015|
Experimental: active excimer laser
308 nm excimer laser treatment: treatment with the laser by a dose protocol with increasing output.
Device: 308 nm excimer laser
Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
Sham Comparator: Sham 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
Sham laser treatment to the control side biweekly for a total of 8 weeks.
- Modified NAPSI Score (Nail Psoriasis Severity Index) [ Time Frame: at 16 weeks ]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.
- Patient Assessment of Nail Psoriasis Activity [ Time Frame: at 16 weeks ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168933
|United States, Utah|
|University of Utah, Department of Dermatology|
|Salt Lake City, Utah, United States, 84132|