Nail PsoriasisNAPSINCT02168933
308nm Excimer Laser for Treatment of Fingernail Psoriasis
A study testing 308 nm excimer laser in people with Nail Psoriasis, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- 308 nm excimer laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah, Department of Dermatology
Salt Lake City, Utah, 84132
About this study
Official title: Randomized Controlled Trial of 308 nm Excimer Laser for Treatment of Nail Psoriasis
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.
- Conditions
- Nail Psoriasis
- Being tested
- 308 nm excimer laser, Sham laser
- Keywords
- psoriasis, nail, laser, excimer, treatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
308 nm excimer laserDevice
Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
Sham laserDevice
Sham laser treatment to the control side biweekly for a total of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| active excimer laser | Experimental | 308 nm excimer laser treatment: treatment with the laser by a dose protocol with increasing output. Receives: Device: 308 nm excimer laser |
| Sham excimer laser | Sham comparator | 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. Receives: Device: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified NAPSI Score (Nail Psoriasis Severity Index)
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.
Measured: at 16 weeks
Secondary outcomes (1)
Patient Assessment of Nail Psoriasis Activity
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).
Measured: at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Dermatologic Surgery
- Responsible party
- Principal investigator, Kristina Callis, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168933
- Sponsor's protocol ID
- FP00004323
- Other IDs
- 10032937
- Acronym
- NAPSI
- Status last verified
- Sep 2019
- First submitted
- 18 Jun 2014
- Last updated
- 18 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Augustin M, Herberger K, Hintzen S, Heigel H, Franzke N, Schafer I. Prevalence of skin lesions and need for treatment in a cohort of 90 880 workers. Br J Dermatol. 2011 Oct;165(4):865-73. doi: 10.1111/j.1365-2133.2011.10436.x.
PubMed 21623753Schafer I, Rustenbach SJ, Radtke M, Augustin J, Glaeske G, Augustin M. [Epidemiology of psoriasis in Germany--analysis of secondary health insurance data]. Gesundheitswesen. 2011 May;73(5):308-13. doi: 10.1055/s-0030-1252022. Epub 2010 Jun 11. German.
PubMed 20544588de Jong EM, Seegers BA, Gulinck MK, Boezeman JB, van de Kerkhof PC. Psoriasis of the nails associated with disability in a large number of patients: results of a recent interview with 1,728 patients. Dermatology. 1996;193(4):300-3. doi: 10.1159/000246274.
PubMed 8993953Klaassen KM, van de Kerkhof PC, Pasch MC. Nail psoriasis: a questionnaire-based survey. Br J Dermatol. 2013 Aug;169(2):314-9. doi: 10.1111/bjd.12354.
PubMed 23550612van der Velden HM, Klaassen KM, van de Kerkhof PC, Pasch MC. Fingernail psoriasis reconsidered: a case-control study. J Am Acad Dermatol. 2013 Aug;69(2):245-52. doi: 10.1016/j.jaad.2013.02.009. Epub 2013 Mar 28.
PubMed 23541759de Vries AC, Bogaards NA, Hooft L, Velema M, Pasch M, Lebwohl M, Spuls PI. Interventions for nail psoriasis. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD007633. doi: 10.1002/14651858.CD007633.pub2.
PubMed 23440816Marx JL, Scher RK. Response of psoriatic nails to oral photochemotherapy. Arch Dermatol. 1980 Sep;116(9):1023-24.
PubMed 7416754[Narrow spectrum (311 nm) phototherapy in treatment of psoriatic nail]. Georgian Med News. 2009 Feb;(167):56-9. Russian.
PubMed 19276472Aubin F, Vigan M, Puzenat E, Blanc D, Drobacheff C, Deprez P, Humbert P, Laurent R. Evaluation of a novel 308-nm monochromatic excimer light delivery system in dermatology: a pilot study in different chronic localized dermatoses. Br J Dermatol. 2005 Jan;152(1):99-103. doi: 10.1111/j.1365-2133.2005.06320.x.
PubMed 15656808Mudigonda T, Dabade TS, Feldman SR. A review of protocols for 308 nm excimer laser phototherapy in psoriasis. J Drugs Dermatol. 2012 Jan;11(1):92-7.
PubMed 22206083Mudigonda T, Dabade TS, West CE, Feldman SR. Therapeutic modalities for localized psoriasis: 308-nm UVB excimer laser versus nontargeted phototherapy. Cutis. 2012 Sep;90(3):149-54.
PubMed 23094316Al-Mutairi N, Al-Haddad A. Targeted phototherapy using 308 nm Xecl monochromatic excimer laser for psoriasis at difficult to treat sites. Lasers Med Sci. 2013 Jul;28(4):1119-24. doi: 10.1007/s10103-012-1210-4. Epub 2012 Sep 28.
PubMed 23053247Asawanonda P, Anderson RR, Chang Y, Taylor CR. 308-nm excimer laser for the treatment of psoriasis: a dose-response study. Arch Dermatol. 2000 May;136(5):619-24. doi: 10.1001/archderm.136.5.619.
PubMed 10815855Rich P, Scher RK. Nail Psoriasis Severity Index: a useful tool for evaluation of nail psoriasis. J Am Acad Dermatol. 2003 Aug;49(2):206-12. doi: 10.1067/s0190-9622(03)00910-1.
PubMed 12894066Aktan S, Ilknur T, Akin C, Ozkan S. Interobserver reliability of the Nail Psoriasis Severity Index. Clin Exp Dermatol. 2007 Mar;32(2):141-4. doi: 10.1111/j.1365-2230.2006.02305.x. Epub 2006 Nov 27.
PubMed 17137477
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of 308 nm Excimer Laser for Treatment of Nail Psoriasis
- ClinicalTrials.gov ID
- NCT02168933
- Acronym / sponsor ID
- NAPSI / FP00004323
- Conditions
- Nail Psoriasis
- Keywords
- psoriasis, nail, laser, excimer, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- American Society for Dermatologic Surgery
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active excimer laser | Experimental | Device: 308 nm excimer laser308 nm excimer laser treatment: treatment with the laser by a dose protocol with increasing output. |
| Sham excimer laser | Sham comparator | Device: Sham laserSham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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. •
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 308 nm excimer laserBiweekly treatments with 308 nm excimer laser for a total of 8 weeks | Device | active excimer laser |
| Sham laserSham laser treatment to the control side biweekly for a total of 8 weeks. | Device | Sham excimer laser |
Primary outcome
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.
1 secondary outcome
Patient Assessment of Nail Psoriasis Activity
Time frame: at 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21623753Augustin M, Herberger K, Hintzen S, Heigel H, Franzke N, Schafer I. Prevalence of skin lesions and need for treatment in a cohort of 90 880 workers. Br J Dermatol. 2011 Oct;165(4):865-73. doi: 10.1111/j.1365-2133.2011.10436.x.
- Background: PubMed 20544588Schafer I, Rustenbach SJ, Radtke M, Augustin J, Glaeske G, Augustin M. [Epidemiology of psoriasis in Germany--analysis of secondary health insurance data]. Gesundheitswesen. 2011 May;73(5):308-13. doi: 10.1055/s-0030-1252022. Epub 2010 Jun 11. German.
- Background: PubMed 8993953de Jong EM, Seegers BA, Gulinck MK, Boezeman JB, van de Kerkhof PC. Psoriasis of the nails associated with disability in a large number of patients: results of a recent interview with 1,728 patients. Dermatology. 1996;193(4):300-3. doi: 10.1159/000246274.
- Background: PubMed 23550612Klaassen KM, van de Kerkhof PC, Pasch MC. Nail psoriasis: a questionnaire-based survey. Br J Dermatol. 2013 Aug;169(2):314-9. doi: 10.1111/bjd.12354.
- Background: PubMed 23541759van der Velden HM, Klaassen KM, van de Kerkhof PC, Pasch MC. Fingernail psoriasis reconsidered: a case-control study. J Am Acad Dermatol. 2013 Aug;69(2):245-52. doi: 10.1016/j.jaad.2013.02.009. Epub 2013 Mar 28.
- Background: PubMed 23440816de Vries AC, Bogaards NA, Hooft L, Velema M, Pasch M, Lebwohl M, Spuls PI. Interventions for nail psoriasis. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD007633. doi: 10.1002/14651858.CD007633.pub2.
- Background: PubMed 7416754Marx JL, Scher RK. Response of psoriatic nails to oral photochemotherapy. Arch Dermatol. 1980 Sep;116(9):1023-24.
- Background: PubMed 19276472[Narrow spectrum (311 nm) phototherapy in treatment of psoriatic nail]. Georgian Med News. 2009 Feb;(167):56-9. Russian.
- Background: PubMed 15656808Aubin F, Vigan M, Puzenat E, Blanc D, Drobacheff C, Deprez P, Humbert P, Laurent R. Evaluation of a novel 308-nm monochromatic excimer light delivery system in dermatology: a pilot study in different chronic localized dermatoses. Br J Dermatol. 2005 Jan;152(1):99-103. doi: 10.1111/j.1365-2133.2005.06320.x.
- Background: PubMed 22206083Mudigonda T, Dabade TS, Feldman SR. A review of protocols for 308 nm excimer laser phototherapy in psoriasis. J Drugs Dermatol. 2012 Jan;11(1):92-7.
- Background: PubMed 23094316Mudigonda T, Dabade TS, West CE, Feldman SR. Therapeutic modalities for localized psoriasis: 308-nm UVB excimer laser versus nontargeted phototherapy. Cutis. 2012 Sep;90(3):149-54.
- Background: PubMed 23053247Al-Mutairi N, Al-Haddad A. Targeted phototherapy using 308 nm Xecl monochromatic excimer laser for psoriasis at difficult to treat sites. Lasers Med Sci. 2013 Jul;28(4):1119-24. doi: 10.1007/s10103-012-1210-4. Epub 2012 Sep 28.
Related trials for Nail Psoriasis
Not yet recruiting
Efficacy of Fractional Co2 Laser With Topical Tacrolimus 0.1 in the Treatment of Nail Psoriasis
Nail Psoriasis
RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
Active, not recruitingPhase 2
Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study
Nail Psoriasis
Recruiting
Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy
Nail Psoriasis
Active, not recruitingObservational study
Psorcast Mobile Study
Psoriatic Arthritis, Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 308 nm excimer laser in people with Nail Psoriasis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified NAPSI Score (Nail Psoriasis Severity Index) (time frame: at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02168933, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.