Trial Outcomes & Findings for 308nm Excimer Laser for Treatment of Fingernail Psoriasis (NCT NCT02168933)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

at 16 weeks

Results posted on

2019-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants all participants received 308 nm excimer laser treatment on one hand, and sham laser treatment on the other hand 308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

308nm Excimer Laser for Treatment of Fingernail Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=8 Participants all study participants received 308 nm excimer laser treatment to one hand and sham laser to the other hand. 308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
Age, Continuous	45 years n=39 Participants
Sex: Female, Male Female	1 Participants n=39 Participants
Sex: Female, Male Male	7 Participants n=39 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active n=7 Participants 308 nm excimer laser treatment 308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks 308 nm excimer laser: Laser to the non-control side	Sham n=7 Participants Sham laser treatment. Sham laser: Biweekly treatments with Sham laser for a total of 8 weeks. Sham laser: Sham laser treatment to the control side (308 nm excimer laser with cover in place preventing patient from exposure to laser energy).
Modified NAPSI Score (Nail Psoriasis Severity Index)	6.3 units on a scale Standard Deviation 1.8	6.0 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Active n=7 Participants 308 nm excimer laser treatment 308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks 308 nm excimer laser: Laser to the non-control side	Sham n=7 Participants Sham laser treatment. Sham laser: Biweekly treatments with Sham laser for a total of 8 weeks. Sham laser: Sham laser treatment to the control side (308 nm excimer laser with cover in place preventing patient from exposure to laser energy).
Patient Assessment of Nail Psoriasis Activity	58.6 units on a scale Standard Deviation 33.0	55.4 units on a scale Standard Deviation 24.3

Adverse Events

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristina Callis-Duffin

University of Utah, Derpartment of Dermatology

Phone: 8015816465

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place