<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03263624</url>
  </required_header>
  <id_info>
    <org_study_id>ltns</org_study_id>
    <nct_id>NCT03263624</nct_id>
  </id_info>
  <brief_title>Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nail psoriasis has a high incidence amongst patients with psoriasis.It is estimated to affect&#xD;
      80% of psoriatic patients at some time during their lives and has a significant adverse&#xD;
      influence on their quality of life.&#xD;
&#xD;
      Treatment of nail psoriasis is disappointing, as it is refractory to treatment, with&#xD;
      conventional therapies often having little effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The characteristic lesions affecting the nail present as 'oil drop' discoloration, splinter&#xD;
      haemorrhages, subungual hyperkeratosis, and onycholysis in the nail bed or pitting,&#xD;
      leuconychia, erythema of the lunula and crumbling in the nail matrix.Diagnosis is customarily&#xD;
      made by patient history and physical examination, though it may be necessary to rule out&#xD;
      onychomycosis as a differential diagnosis.&#xD;
&#xD;
      The nail psoriasis severity index has recently been reported as a possible reproducible,&#xD;
      objective, and simple tool for clinical assessment of psoriatic nail disease.&#xD;
&#xD;
      The modified target nail psoriasis severity index has been proposed for target nail&#xD;
      assessment which would give a degree of gradation for each parameter of 0 to 3 (0 = none, 1 =&#xD;
      mild, 2 = moderate, and 3 = severe) in each quadrant.The topical therapies include topical&#xD;
      and intralesional corticosteroids , topical vitamin D3 analogues (calcipotriol) , topical&#xD;
      tacrolimus and tazarotene[8]. The efficacy of these topical therapies in nail disease is&#xD;
      limited mainly by the impenetrability or low penetrability of the nail and nail matrix. In&#xD;
      patients with nail psoriasis that is resistant to topical therapies, conventional systemic&#xD;
      therapies (e.g., phototherapy, retinoids, cyclosporine, methotrexate) have been shown to be&#xD;
      partially effective. More recently, biological therapies (e.g., infliximab, adalimumab,&#xD;
      alefacept, etanercept) have proven efficacy in psoriasis and psoriatic arthritis, and some&#xD;
      are effective in treating nail disease in patients with psoriasis .&#xD;
&#xD;
      Previous study proved successful treatment of onychodystrophy using fractional carbon dioxide&#xD;
      laser with topical steroid. Fractional Carbon dioxide laser might be an effective therapy for&#xD;
      nail psoriasis due to its ablative ability which produce microscopic holes that perhaps&#xD;
      improve topical drug delivery. Moreover it was hypothesized that tissue ablation and&#xD;
      remodelling process stimulate rejuvenation of the abnormal nail bed.The investigators&#xD;
      hypothesized that the combination of Fractional carbon dioxide laser and topical tazarotene&#xD;
      treatment will have a higher therapeutic effect on nail psoriasis through multiple mechanism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">November 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of clinically improved patients using modified nail psoriasis severity index.</measure>
    <time_frame>three months</time_frame>
    <description>clinical assessment using modified nail psoriasis severity index.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Nail Psoriasis</condition>
  <arm_group>
    <arm_group_label>Group (A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fractional carbon dioxide laser plus tazarotene 0.1% cream</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group (B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tazarotene Cream 0.1%</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fractional carbon dioxide laser</intervention_name>
    <description>One hand of each patient will receive three sessions of fractional carbon dioxide laser at four- week interval.</description>
    <arm_group_label>Group (A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tazarotene Cream 0.1%</intervention_name>
    <description>tazarotene cream 0.1% once daily</description>
    <arm_group_label>Group (A)</arm_group_label>
    <arm_group_label>Group (B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Thirty patients with bilateral fingernail psoriasis will be recruited from the&#xD;
             Dermatology Outpatient Clinic, Assiut University Hospital.&#xD;
&#xD;
          2. The diagnosis will be based upon the clinical characteristics of nail psoriasis.&#xD;
&#xD;
          3. Patients will be included after they have stopped any systemic therapy for at least 8&#xD;
             weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pregnant or lactating woman&#xD;
&#xD;
          2. patients with history of photosensitivity.&#xD;
&#xD;
          3. Patients who discontinued or just started to receive new systemic therapy or&#xD;
             phototherapy during the study period will be dropped from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <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.</citation>
    <PMID>12879333</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24852726</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16307651</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12894066</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17216680</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23762032</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17572277</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24164919</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17340027</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25111355</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22818395</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22243768</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27226341</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ayat Mahmoud</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>psoriasis</keyword>
  <keyword>laser</keyword>
  <keyword>nail</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Nail Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tazarotene</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03263624
org study id: ltns
nct id: NCT03263624
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: percentage of clinically improved patients using modified nail psoriasis severity index.
time frame: three months
description: clinical assessment using modified nail psoriasis severity index.
arm group label: Group (A)
arm group type: Experimental
description: fractional carbon dioxide laser plus tazarotene 0.1% cream
arm group label: Group (B)
arm group type: Active Comparator
description: Tazarotene Cream 0.1%
intervention type: Device
intervention name: fractional carbon dioxide laser
description: One hand of each patient will receive three sessions of fractional carbon dioxide laser at four- week interval.
arm group label: Group (A)
intervention type: Drug
intervention name: Tazarotene Cream 0.1%
description: tazarotene cream 0.1% once daily
arm group label: Group (A)
arm group label: Group (B)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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.
PMID: 12879333
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.
PMID: 24852726
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.
PMID: 16307651
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.
PMID: 12894066
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.
PMID: 17216680
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.
PMID: 23762032
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.
PMID: 17572277
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.
PMID: 24164919
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.
PMID: 17340027
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.
PMID: 25111355
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.
PMID: 22818395
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.
PMID: 22243768
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.
PMID: 27226341
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ayat Mahmoud
investigator title: Principal Investigator
mesh term: Psoriasis
mesh term: Nail Diseases
mesh term: Tazarotene
sharing ipd: No