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History of Changes for Study: NCT00871728
Study Using SCIO(Scoring Clinical Index for Onychomycosis) in Onychomycosis Treating With ITRACONOZOLE
Latest version (submitted June 24, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 26, 2009 None (earliest Version on record)
2 April 30, 2009 Study Status
3 May 6, 2009 Study Status and Eligibility
4 May 28, 2009 Eligibility and Study Status
5 June 10, 2009 Study Status and Eligibility
6 June 25, 2009 Conditions, Study Description, Contacts/Locations, Eligibility, Arms and Interventions, Study Status and Study Identification
7 July 2, 2009 Study Status
8 August 27, 2009 Recruitment Status, Study Status, Contacts/Locations and Study Design
9 September 4, 2009 Study Status and Study Design
10 April 26, 2010 Study Status
11 April 29, 2013 Study Status, Outcome Measures, Arms and Interventions, Study Identification, Study Design, Conditions, Study Description, Results, Eligibility, Oversight and Sponsor/Collaborators
12 June 24, 2013 Outcome Measures and Study Status
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Study NCT00871728
Submitted Date:  March 26, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR013837
Brief Title: Study Using SCIO(Scoring Clinical Index for Onychomycosis) in Onychomycosis Treating With ITRACONOZOLE
Official Title: SCIO in Toenail Onychomycosis Treating With ITRACONAZOLE Capsules
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2009
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: February 13, 2009
First Submitted that
Met QC Criteria:
March 26, 2009
First Posted: March 30, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 26, 2009
Last Update Posted: March 30, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Korea, Ltd., Korea
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The purpose of this study, using SCIO, will assess patients with toenail onychomycosis confirmed by KOH and culture positive, identify the change of SCIO score after Sporanox capsule administration, and address the relationship between the change of SCIO score and mycological cure rate/ clinical improvement.
Detailed Description:

Scoring Clinical Index for Onychomycosis (SCIO) is based on clinical state and includes important factors which may have an influence on the results of onychomycosis treatment. Considering an influence on results, the ratio of these factors is used, and the appropriate treatment plan is applied according to the calculated SCIO score. Such factors include clinical form, depth of infected site, subungual(under nail) hyperkeratosis, etc. Because the growth rate of nail is dependent on onychomycosis site, SCIO considers it as a growth factor and includes when scoring. The SCIO score is from 1 to 30, indicating the higher score is, the more severe it is. The score is specified into seven stages, suggesting a specific treatment at each stage, which makes it possible to consistently apply the treatment based on clinical state. SCIO can compare the severity of nails even in case of different clinical states of onychomycosis and demographic characteristics, and based on this, SCIO may be used as a standard about the effectiveness of treatment. This clinical study is to assess the decrease of SCIO score and mycological, clinical effectiveness of Sporanox capsules administered to patients who need an oral drug for toenail onychomycosis.

In itraconazole (ICZ) cycle therapy, one cycle consists of taking ICZ 100 mg 2 capsules twice a day consecutively for 1 week and not taking for next 3 weeks. In this study ICZ has 3 cycles, being administered to toenail onychomycosis at week 1, week 5 and week 9.

Open or close this module Conditions
Conditions: Onychomycosis.
Keywords: Onychomycosis
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 107 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Drug: Itraconazole; Naillacquer
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in Scoring Clinical Index for Onychomycosis (SCIO) score
Secondary Outcome Measures:
1. Mycological cure rate (KOH smear and culture test) and clinical cure rate (by appearance)
Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Onychomycosis patients whose etiologic agent is identified by KOH smear and culture and who signed an informed consent form for the study participation
  • SCIO > 9
  • Healthy patients in general in following items: Medical and medication history, Physical examination prior to administration time, Vital signs: Blood pressure, pulse, Clinical laboratory tests: Clinical test results < 2 X normal range
  • Women of child-bearing age who use acceptable contraceptives
  • Patients who can read and understand written instructions - Patients who understood the features of the clinical study after listening to explanation and signed an informed consent form

Exclusion Criteria:

  • Patients with psoriasis
  • Diabetics who take an anti-diabetic drug
  • Clinical evidence of arterial insufficiency or peripheral vascular disease
  • Decreased ventricular function like congestive heart failure or medical history of congestive heart failure
  • Applied a topical antifungal agent (NAILLACQUER) within 1 month prior to study medication administration
  • Took an oral antifungal agent within 3 month prior to study medication administration
  • Onychomycosis on the 5th toenail only
  • Hepatic function test results > 2 X normal range
  • Pregnancy or breast-feeding
  • Hypersensitivity to the study medication or any ingredient of the medication
  • Administering one of the following drugs and its continuous administration of the drugs during the study period
  • Allergy or hypersensitivity to azole antifungual drugs
  • Condition or disease which may interfere participation in the study at the investigator's discretion based on hemo-biochemistry test
  • The investigator's discretion due to serious other disease which can't be treated with the study medication at same time
Open or close this module Contacts/Locations
Central Contact Person: This study is not yet recruiting patients. Please check back for future recruiting sites, or email
Email: info1@veritasmedicine.com
Study Officials: Janssen Korea, Ltd. Clinical Trial
Study Director
Janssen Korea, Ltd., Korea
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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