<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/NCT01703325</url>
  </required_header>
  <id_info>
    <org_study_id>Si599/2010</org_study_id>
    <nct_id>NCT01703325</nct_id>
  </id_info>
  <brief_title>Comparison of Efficacy of Intralesional Triamcinolone Injection and Clobetasol Propionate Ointment for Psoriatic Nails</brief_title>
  <official_title>Comparison of Efficacy and Safety of Psoriatic Nails Treatment Between by Intralesional 0.1%Triamcinolone Injection and Topical 0.05%Clobetasol Propionate Ointment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects&#xD;
      both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect&#xD;
      in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis,&#xD;
      discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of&#xD;
      psoriatic nails is using topical high- potent steroids however topical steroids are limited&#xD;
      their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of&#xD;
      such a treatment can lead to skin atrophy and report in the case of &quot;Disappearing digits&quot;.&#xD;
      Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory&#xD;
      results without any serious permanent adverse effects. At present, there is no comparison&#xD;
      study between intralesional steroid and ultrapotent topical steroid for the treatment of&#xD;
      psoriatic nails.&#xD;
&#xD;
      The purpose of the study is to evaluate the efficacy and safety of intralesional&#xD;
      triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psoriasis is a chronic inflammatory disorder. The nails involvement has been reported up to&#xD;
      40% of psoriatic patients. Psoriatic nails can significantly affect a quality of life of&#xD;
      patients. Psoriasis affects both nail matrix and nail bed. Pitting, leukonychia and red spots&#xD;
      in lunula indicate a defect in the nail matrix. Psoriasis can change the nail bed as the&#xD;
      results in onycholysis, discoloration, splinter hemorrhage and subungual hyperkeratosis. The&#xD;
      main treatment of psoriatic nails is using topical high- potent steroids however topical&#xD;
      steroids are limited their ability to penetrate deep nail matrix or nail bed which are the&#xD;
      main pathology. Use of such a treatment can lead to skin atrophy and report in the case of&#xD;
      &quot;Disappearing digits&quot;. Previous studies of steroid injection in the treatment of psoriatic&#xD;
      nails show satisfactory results without any serious permanent adverse effects. At present,&#xD;
      there is no comparison study between intralesional steroid and ultrapotent topical steroid&#xD;
      for the treatment of psoriatic nails.&#xD;
&#xD;
      The purpose of the study is to evaluate the efficacy and safety of intralesional&#xD;
      triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change in the NAPSI (Nail Psoriasis Severit Index) score of psoriatic nails after treatment with intralesional 0.1%triamcinolone injection vs.topical 0.05% clobetasol propionate ointment</measure>
    <time_frame>6 months</time_frame>
    <description>1. To compare the percent change in the NAPSI (Nail Psoriasis Severity Index) score of Psoriatic nails after treatment with intralesional 0.1%triamcinolone injection vs.topical 0.05% clobetasol propionate ointment and controlled untreated group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment</measure>
    <time_frame>6 months</time_frame>
    <description>Observe the possible adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment treatment for psoriatic nails.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Psoriatic Nails</condition>
  <arm_group>
    <arm_group_label>triamcinolone injection (10 mg/ml)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C&#xD;
Group A: Triamcinolone injection (10 mg/ml) on 4 sites for the pathology from both nail matrix (B) and nail bed (A) or 2 sites for the pathology from either nail matrix(B) or nail bed (A) as shown in picture, the EMLA was applied before injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical 0.05% clobetasol ointment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C Apply Topical 0.05% clobetasol propionate ointment on the nail fold twice daily for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controlled group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C Controlled group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.1% triamcinolone , 0.05% clobetasol propionate ointment</intervention_name>
    <description>Three finger nails are chosen from the equally average NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C&#xD;
Group A: Triamcinolone injection (10 mg/ml) on 4 sites for the pathology from both nail matrix (B) and nail bed (A) or 2 sites for the pathology from either nail matrix(B) or nail bed (A) as shown in picture, the EMLA was applied before injection&#xD;
Group B: Apply Topical 0.05% clobetasol propionate ointment (Dermovate®) on the nail fold twice daily for 6 months&#xD;
Group C: Controlled group</description>
    <arm_group_label>Topical 0.05% clobetasol ointment</arm_group_label>
    <arm_group_label>triamcinolone injection (10 mg/ml)</arm_group_label>
    <other_name>Dermovate ointment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged over 18 years old who have at least 3 psoriatic finger nails resembly&#xD;
             severity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients are receiving the systemic therapy of psoriasis&#xD;
&#xD;
          2. Patients discontinued the systemic therapy less than 3 months and topical therapy less&#xD;
             than 1 month&#xD;
&#xD;
          3. Positive results for the microscopic study of fungus in finger nails&#xD;
&#xD;
          4. History of steroids or EMLA allergy&#xD;
&#xD;
          5. Pregnancy or nursing&#xD;
&#xD;
          6. Any skin infection at the site of the treatment&#xD;
&#xD;
          7. Human immunodeficiency virus subjects&#xD;
&#xD;
          8. History of malignancy or during the treatment of malignancy&#xD;
&#xD;
          9. Patients who have psychological disorder&#xD;
&#xD;
         10. Patients who have bleeding disorder or receiving anticoagulation drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chanisada Wongpraparut, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine Siriraj Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siriraj Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>June 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>October 7, 2012</last_update_submitted>
  <last_update_submitted_qc>October 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>chanisada tuchinda</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Psoriatic nails</keyword>
  <keyword>Triamcinolone injection</keyword>
  <keyword>clobetasol propionate</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Clobetasol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01703325
org study id: Si599/2010
nct id: NCT01703325
lead sponsor: 
has dmc: Yes
Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects
      both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect
      in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis,
      discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of
      psoriatic nails is using topical high- potent steroids however topical steroids are limited
      their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of
      such a treatment can lead to skin atrophy and report in the case of "Disappearing digits".
      Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory
      results without any serious permanent adverse effects. At present, there is no comparison
      study between intralesional steroid and ultrapotent topical steroid for the treatment of
      psoriatic nails.

      The purpose of the study is to evaluate the efficacy and safety of intralesional
      triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.
Psoriasis is a chronic inflammatory disorder. The nails involvement has been reported up to
      40% of psoriatic patients. Psoriatic nails can significantly affect a quality of life of
      patients. Psoriasis affects both nail matrix and nail bed. Pitting, leukonychia and red spots
      in lunula indicate a defect in the nail matrix. Psoriasis can change the nail bed as the
      results in onycholysis, discoloration, splinter hemorrhage and subungual hyperkeratosis. The
      main treatment of psoriatic nails is using topical high- potent steroids however topical
      steroids are limited their ability to penetrate deep nail matrix or nail bed which are the
      main pathology. Use of such a treatment can lead to skin atrophy and report in the case of
      "Disappearing digits". Previous studies of steroid injection in the treatment of psoriatic
      nails show satisfactory results without any serious permanent adverse effects. At present,
      there is no comparison study between intralesional steroid and ultrapotent topical steroid
      for the treatment of psoriatic nails.

      The purpose of the study is to evaluate the efficacy and safety of intralesional
      triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percent change in the NAPSI (Nail Psoriasis Severit Index) score of psoriatic nails after treatment with intralesional 0.1%triamcinolone injection vs.topical 0.05% clobetasol propionate ointment
time frame: 6 months
description: 1. To compare the percent change in the NAPSI (Nail Psoriasis Severity Index) score of Psoriatic nails after treatment with intralesional 0.1%triamcinolone injection vs.topical 0.05% clobetasol propionate ointment and controlled untreated group.
measure: adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment
time frame: 6 months
description: Observe the possible adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment treatment for psoriatic nails.
arm group label: triamcinolone injection (10 mg/ml)
arm group type: Active Comparator
description: Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C
Group A: Triamcinolone injection (10 mg/ml) on 4 sites for the pathology from both nail matrix (B) and nail bed (A) or 2 sites for the pathology from either nail matrix(B) or nail bed (A) as shown in picture, the EMLA was applied before injection
arm group label: Topical 0.05% clobetasol ointment
arm group type: Active Comparator
description: Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C Apply Topical 0.05% clobetasol propionate ointment on the nail fold twice daily for 6 months
arm group label: Controlled group
arm group type: No Intervention
description: Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C Controlled group
intervention type: Drug
intervention name: 0.1% triamcinolone , 0.05% clobetasol propionate ointment
description: Three finger nails are chosen from the equally average NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C
Group A: Triamcinolone injection (10 mg/ml) on 4 sites for the pathology from both nail matrix (B) and nail bed (A) or 2 sites for the pathology from either nail matrix(B) or nail bed (A) as shown in picture, the EMLA was applied before injection
Group B: Apply Topical 0.05% clobetasol propionate ointment (Dermovate®) on the nail fold twice daily for 6 months
Group C: Controlled group
arm group label: Topical 0.05% clobetasol ointment
arm group label: triamcinolone injection (10 mg/ml)
other name: Dermovate ointment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chanisada Wongpraparut, M.D.
role: Principal Investigator
affiliation: Faculty of Medicine Siriraj Hospital
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: chanisada tuchinda
investigator title: Assistant Professor
mesh term: Triamcinolone
mesh term: Clobetasol