308nm Excimer Laser for Treatment of Fingernail Psoriasis
NCT ID: NCT02168933
Last Updated: 2019-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2014-01-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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active excimer laser
308 nm excimer laser treatment: treatment with the laser by a dose protocol with increasing output.
308 nm excimer laser
Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
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.
Sham laser
Sham laser treatment to the control side biweekly for a total of 8 weeks.
Interventions
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308 nm excimer laser
Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
Sham laser
Sham laser treatment to the control side biweekly for a total of 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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American Society for Dermatologic Surgery
OTHER
University of Utah
OTHER
Responsible Party
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Kristina Callis
M.D.
Locations
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University of Utah, Department of Dermatology
Salt Lake City, Utah, United States
Countries
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References
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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.
Schafer 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.
de 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.
Klaassen 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.
van 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.
de 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.
Marx JL, Scher RK. Response of psoriatic nails to oral photochemotherapy. Arch Dermatol. 1980 Sep;116(9):1023-24.
[Narrow spectrum (311 nm) phototherapy in treatment of psoriatic nail]. Georgian Med News. 2009 Feb;(167):56-9. Russian.
Aubin 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.
Mudigonda 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.
Mudigonda 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.
Al-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.
Asawanonda 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.
Rich 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.
Aktan 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.
Cassell SE, Bieber JD, Rich P, Tutuncu ZN, Lee SJ, Kalunian KC, Wu CW, Kavanaugh A. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007 Jan;34(1):123-9.
Yaemsiri S, Hou N, Slining MM, He K. Growth rate of human fingernails and toenails in healthy American young adults. J Eur Acad Dermatol Venereol. 2010 Apr;24(4):420-3. doi: 10.1111/j.1468-3083.2009.03426.x. Epub 2009 Sep 8.
Ortonne JP, Paul C, Berardesca E, Marino V, Gallo G, Brault Y, Germain JM. A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis. Br J Dermatol. 2013 May;168(5):1080-7. doi: 10.1111/bjd.12060.
de Jong EM, Menke HE, van Praag MC, van De Kerkhof PC. Dystrophic psoriatic fingernails treated with 1% 5-fluorouracil in a nail penetration-enhancing vehicle: a double-blind study. Dermatology. 1999;199(4):313-8. doi: 10.1159/000018281.
Other Identifiers
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10032937
Identifier Type: OTHER
Identifier Source: secondary_id
FP00004323
Identifier Type: -
Identifier Source: org_study_id
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