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308nm Excimer Laser for Treatment of Fingernail Psoriasis (NAPSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168933
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : August 20, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
American Society for Dermatologic Surgery
Information provided by (Responsible Party):
Kristina Callis, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nail Psoriasis
Interventions Device: 308 nm excimer laser
Device: Sham laser
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description

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

Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Arm/Group Title All Study Participants
Hide Arm/Group Description

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

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
45
(19 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
1.Primary Outcome
Title Modified NAPSI Score (Nail Psoriasis Severity Index)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Sham
Hide Arm/Group Description:

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 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).

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (1.8) 6.0  (1.3)
2.Secondary Outcome
Title Patient Assessment of Nail Psoriasis Activity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Sham
Hide Arm/Group Description:

308 nm excimer laser treatment

308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks

Sham 308 nm excimer laser treatment

Sham laser: Sham laser treatment to the control side.

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
58.6  (33.0) 55.4  (24.3)
Time Frame Adverse event data were collected over 16 weeks (entire time of participation for each subject from screening to termination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Sham
Hide Arm/Group Description

308 nm excimer laser treatment

308 nm excimer laser: Biweekly treatments with 308 nm excimer laser for a total of 8 weeks

Sham laser treatment (laser covered with cap so that the patient is not exposed to laser energy)

Sham laser: Biweekly treatments with Sham laser for a total of 8 weeks

All-Cause Mortality
Active Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Active Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristina Callis-Duffin
Organization: University of Utah, Derpartment of Dermatology
Phone: 8015816465
Publications:
Layout table for additonal information
Responsible Party: Kristina Callis, University of Utah
ClinicalTrials.gov Identifier: NCT02168933     History of Changes
Other Study ID Numbers: FP00004323
10032937 ( Other Identifier: University of Utah OSP )
First Submitted: June 18, 2014
First Posted: June 20, 2014
Results First Submitted: October 3, 2016
Results First Posted: August 20, 2019
Last Update Posted: September 18, 2019