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Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease

Primary Purpose

Nail Psoriasis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
fractional carbon dioxide laser
Tazarotene Cream 0.1%
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nail Psoriasis focused on measuring psoriasis, laser, nail

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Thirty patients with bilateral fingernail psoriasis will be recruited from the Dermatology Outpatient Clinic, Assiut University Hospital.
  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:

  1. pregnant or lactating woman
  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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group (A)

    Group (B)

    Arm Description

    fractional carbon dioxide laser plus tazarotene 0.1% cream

    Tazarotene Cream 0.1%

    Outcomes

    Primary Outcome Measures

    percentage of clinically improved patients using modified nail psoriasis severity index.
    clinical assessment using modified nail psoriasis severity index.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 23, 2017
    Last Updated
    August 25, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03263624
    Brief Title
    Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease
    Official Title
    Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic: Nail Disease a Single-blind, Intrapatient Left-to-right Controlled Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2017 (Anticipated)
    Primary Completion Date
    October 1, 2018 (Anticipated)
    Study Completion Date
    November 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Nail psoriasis has a high incidence amongst patients with psoriasis.It is estimated to affect 80% of psoriatic patients at some time during their lives and has a significant adverse influence on their quality of life. Treatment of nail psoriasis is disappointing, as it is refractory to treatment, with conventional therapies often having little effect.
    Detailed Description
    The characteristic lesions affecting the nail present as 'oil drop' discoloration, splinter haemorrhages, subungual hyperkeratosis, and onycholysis in the nail bed or pitting, leuconychia, erythema of the lunula and crumbling in the nail matrix.Diagnosis is customarily made by patient history and physical examination, though it may be necessary to rule out onychomycosis as a differential diagnosis. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nail Psoriasis
    Keywords
    psoriasis, laser, nail

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group (A)
    Arm Type
    Experimental
    Arm Description
    fractional carbon dioxide laser plus tazarotene 0.1% cream
    Arm Title
    Group (B)
    Arm Type
    Active Comparator
    Arm Description
    Tazarotene Cream 0.1%
    Intervention Type
    Device
    Intervention Name(s)
    fractional carbon dioxide laser
    Intervention Description
    One hand of each patient will receive three sessions of fractional carbon dioxide laser at four- week interval.
    Intervention Type
    Drug
    Intervention Name(s)
    Tazarotene Cream 0.1%
    Intervention Description
    tazarotene cream 0.1% once daily
    Primary Outcome Measure Information:
    Title
    percentage of clinically improved patients using modified nail psoriasis severity index.
    Description
    clinical assessment using modified nail psoriasis severity index.
    Time Frame
    three months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Thirty patients with bilateral fingernail psoriasis will be recruited from the Dermatology Outpatient Clinic, Assiut University Hospital. The diagnosis will be based upon the clinical characteristics of nail psoriasis. Patients will be included after they have stopped any systemic therapy for at least 8 weeks Exclusion Criteria: pregnant or lactating woman patients with history of photosensitivity. Patients who discontinued or just started to receive new systemic therapy or phototherapy during the study period will be dropped from the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12879333
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24852726
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16307651
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12894066
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17216680
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23762032
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17572277
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24164919
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17340027
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25111355
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22818395
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22243768
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27226341
    Citation
    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.
    Results Reference
    background

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    Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease

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