Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 20, 2014
Results First Submitted Date  ICMJE October 3, 2016
Results First Posted Date  ICMJE August 20, 2019
Last Update Posted Date September 18, 2019
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
Modified NAPSI Score (Nail Psoriasis Severity Index) [ Time Frame: at 16 weeks ]
Change History Complete list of historical versions of study NCT02168933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
Patient Assessment of Nail Psoriasis Activity [ Time Frame: at 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 308nm Excimer Laser for Treatment of Fingernail Psoriasis
Official Title  ICMJE Randomized Controlled Trial of 308 nm Excimer Laser for Treatment of Nail Psoriasis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nail Psoriasis
Intervention  ICMJE
  • Device: 308 nm excimer laser
    Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
  • Device: Sham laser
    Sham laser treatment to the control side biweekly for a total of 8 weeks.
Study Arms  ICMJE
  • Experimental: active excimer laser
    308 nm excimer laser treatment: treatment with the laser by a dose protocol with increasing output.
    Intervention: Device: 308 nm excimer laser
  • 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.
    Intervention: Device: Sham laser
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2014)
16
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must give written informed consent.
  • Must be at least 18 years old.
  • Must have been diagnosed with stable fingernail psoriasis.
  • Must have fairly symmetric fingernail psoriasis in right and left hand with similar modified NAPSI scores in right and left hand target nails. Target nail is defined as the fingernail with highest modified NAPSI score.
  • Must have active fingernail psoriasis, defined as a target fingernail matrix NAPSI score of at least 2 and modified NAPSI score from a combination of crumbling, onycholysis and pitting at least 2. •
  • No changes in the systemic therapy or nail directed topical therapy during the 16 week study period.

Exclusion criteria:

  • Subjects unable to tolerate frequency of visits.
  • History of intolerance to or worsening of psoriasis with ultraviolet light.
  • Current use of known photosensitizing medications.
  • History of Fitzpatrick Type I skin, photosensitivity, or keloid formation.
  • Any new systemic psoriasis therapy including biologics, conventional systemic immunomodulators, phototherapy, or nail directed topical therapy for the last 3 months prior to enrollment.
  • Any other condition that in the eyes of the investigator will disqualify patient from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168933
Other Study ID Numbers  ICMJE FP00004323
10032937 ( Other Identifier: University of Utah OSP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristina Callis, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE American Society for Dermatologic Surgery
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP