Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease
NCT ID: NCT03263624
Last Updated: 2017-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2017-10-01
2018-11-01
Brief Summary
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Treatment of nail psoriasis is disappointing, as it is refractory to treatment, with conventional therapies often having little effect.
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Detailed Description
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The nail psoriasis severity index has recently been reported as a possible reproducible, objective, and simple tool for clinical assessment of psoriatic nail disease.
The modified target nail psoriasis severity index has been proposed for target nail assessment which would give a degree of gradation for each parameter of 0 to 3 (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in each quadrant.The topical therapies include topical and intralesional corticosteroids , topical vitamin D3 analogues (calcipotriol) , topical tacrolimus and tazarotene\[8\]. The efficacy of these topical therapies in nail disease is limited mainly by the impenetrability or low penetrability of the nail and nail matrix. In patients with nail psoriasis that is resistant to topical therapies, conventional systemic therapies (e.g., phototherapy, retinoids, cyclosporine, methotrexate) have been shown to be partially effective. More recently, biological therapies (e.g., infliximab, adalimumab, alefacept, etanercept) have proven efficacy in psoriasis and psoriatic arthritis, and some are effective in treating nail disease in patients with psoriasis .
Previous study proved successful treatment of onychodystrophy using fractional carbon dioxide laser with topical steroid. Fractional Carbon dioxide laser might be an effective therapy for nail psoriasis due to its ablative ability which produce microscopic holes that perhaps improve topical drug delivery. Moreover it was hypothesized that tissue ablation and remodelling process stimulate rejuvenation of the abnormal nail bed.The investigators hypothesized that the combination of Fractional carbon dioxide laser and topical tazarotene treatment will have a higher therapeutic effect on nail psoriasis through multiple mechanism.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group (A)
fractional carbon dioxide laser plus tazarotene 0.1% cream
fractional carbon dioxide laser
One hand of each patient will receive three sessions of fractional carbon dioxide laser at four- week interval.
Tazarotene Cream 0.1%
tazarotene cream 0.1% once daily
Group (B)
Tazarotene Cream 0.1%
Tazarotene Cream 0.1%
tazarotene cream 0.1% once daily
Interventions
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fractional carbon dioxide laser
One hand of each patient will receive three sessions of fractional carbon dioxide laser at four- week interval.
Tazarotene Cream 0.1%
tazarotene cream 0.1% once daily
Eligibility Criteria
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Inclusion Criteria
2. The diagnosis will be based upon the clinical characteristics of nail psoriasis.
3. Patients will be included after they have stopped any systemic therapy for at least 8 weeks
Exclusion Criteria
2. patients with history of photosensitivity.
3. Patients who discontinued or just started to receive new systemic therapy or phototherapy during the study period will be dropped from the study.
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ayat Mahmoud
Principal Investigator
References
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Salomon J, Szepietowski JC, Proniewicz A. Psoriatic nails: a prospective clinical study. J Cutan Med Surg. 2003 Jul-Aug;7(4):317-21. doi: 10.1007/s10227-002-0143-0. Epub 2003 Jul 28.
Sanchez-Regana M, Aldunce Soto MJ, Belinchon Romero I, Ribera Pibernat M, Lafuente-Urrez RF, Carrascosa Carrillo JM, Ferrandiz Foraster C, Puig Sanz L, Dauden Tello E, Vidal Sarro D, Ruiz-Villaverde R, Fonseca Capdevila E, Rodriguez Cerdeira MC, Alsina Gibert MM, Herrera Acosta E, Marron Moya SE; en representacion del Grupo Espanol de Psoriasis de la Academia Espanola de Dermatologia y Venereologia. Evidence-based guidelines of the spanish psoriasis group on the use of biologic therapy in patients with psoriasis in difficult-to-treat sites (nails, scalp, palms, and soles). Actas Dermosifiliogr. 2014 Dec;105(10):923-34. doi: 10.1016/j.ad.2014.02.015. Epub 2014 May 19. English, Spanish.
Grover C, Reddy BS, Uma Chaturvedi K. Diagnosis of nail psoriasis: importance of biopsy and histopathology. Br J Dermatol. 2005 Dec;153(6):1153-8. doi: 10.1111/j.1365-2133.2005.06862.x.
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.
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.
Oram Y, Akkaya AD. Treatment of nail psoriasis: common concepts and new trends. Dermatol Res Pract. 2013;2013:180496. doi: 10.1155/2013/180496. Epub 2013 May 13.
Jiaravuthisan MM, Sasseville D, Vender RB, Murphy F, Muhn CY. Psoriasis of the nail: anatomy, pathology, clinical presentation, and a review of the literature on therapy. J Am Acad Dermatol. 2007 Jul;57(1):1-27. doi: 10.1016/j.jaad.2005.07.073.
Lim EH, Seo YJ, Lee JH, Im M. Onychodystrophy treated using fractional carbon dioxide laser therapy and topical steroids: new treatment options for nail dystrophy. Dermatol Surg. 2013 Dec;39(12):1931-3. doi: 10.1111/dsu.12365. Epub 2013 Oct 26. No abstract available.
Rigopoulos D, Gregoriou S, Katsambas A. Treatment of psoriatic nails with tazarotene cream 0.1% vs. clobetasol propionate 0.05% cream: a double-blind study. Acta Derm Venereol. 2007;87(2):167-8. doi: 10.2340/00015555-0195. No abstract available.
Velez NF, Jellinek NJ. Response to onychodystrophy treated using fractional carbon dioxide laser therapy and topical steroids. Dermatol Surg. 2014 Jul;40(7):801-2. doi: 10.1111/DSU.0000000000000036. No abstract available.
Fischer-Levancini C, Sanchez-Regana M, Llambi F, Collgros H, Exposito-Serrano V, Umbert-Millet P. Nail psoriasis: treatment with tazarotene 0.1% hydrophilic ointment. Actas Dermosifiliogr. 2012 Oct;103(8):725-8. doi: 10.1016/j.ad.2012.04.008. Epub 2012 Jul 19. English, Spanish.
Treewittayapoom C, Singvahanont P, Chanprapaph K, Haneke E. The effect of different pulse durations in the treatment of nail psoriasis with 595-nm pulsed dye laser: a randomized, double-blind, intrapatient left-to-right study. J Am Acad Dermatol. 2012 May;66(5):807-12. doi: 10.1016/j.jaad.2011.12.015. Epub 2012 Jan 13.
Maranda EL, Nguyen AH, Lim VM, Hafeez F, Jimenez JJ. Laser and light therapies for the treatment of nail psoriasis. J Eur Acad Dermatol Venereol. 2016 Aug;30(8):1278-84. doi: 10.1111/jdv.13678. Epub 2016 May 26.
Other Identifiers
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ltns
Identifier Type: -
Identifier Source: org_study_id
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