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

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.

Condition or disease Intervention/treatment Phase
Nail Psoriasis Device: 308 nm excimer laser Device: Sham laser Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Utah
University of Utah, Department of Dermatology
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
American Society for Dermatologic Surgery

Publications:

Layout table for additonal information
Responsible Party: Kristina Callis, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT02168933     History of Changes
Other Study ID Numbers: FP00004323
10032937 ( Other Identifier: University of Utah OSP )
First Posted: June 20, 2014    Key Record Dates
Results First Posted: August 20, 2019
Last Update Posted: September 18, 2019
Last Verified: September 2019
Keywords provided by Kristina Callis, University of Utah:
psoriasis
nail
laser
excimer
treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases