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Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280927
Recruitment Status : Active, not recruiting
First Posted : September 13, 2017
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Brief Summary:
The antifungal efficacy and safety of Jublia® topical solution will be assessed through an administration for 48 weeks to patients diagnosed with a mild or moderate onychomycosis due to dermatophyte.

Condition or disease Intervention/treatment Phase
Mild to Moderate Onychomycosis Due to Dermatophyte Drug: Jublia® Phase 4

Detailed Description:
Evaluate anti-fungal activity and safety of efinaconazole in patients with mild to moderate toenail onychomycosis caused by dermatophytes that received a 48-week administration of efinaconazole.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Non-controlled, Single-arm Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Jublia® Drug: Jublia®
Jublia® topical solution




Primary Outcome Measures :
  1. Completely cured subjects [ Time Frame: 52 weeks ]
    The ratio of completely cured subjects


Secondary Outcome Measures :
  1. Complete or almost complete cure rates [ Time Frame: 52 weeks ]
    The ratio of subjects showing less than 5% of infection area

  2. Mycologic cure rates [ Time Frame: 52 weeks ]
    Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection.

  3. Clinical efficacy rates [ Time Frame: 52 weeks ]
    The ratio of subjects affected target nail area less than 10%



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female subjects of ages in the range over 19.
  • The subjects diagnosed with onychomycosis in up to 6 toenails at least

    1 great toenail woth no fingernails

  • The subjects diagnosed with a mild to moderate onychomycosis (20% to 50% of surface of target nail without nail matrix infection or dermatophytoma)
  • The subjects having target nails less than 3mm in thickness and over 3mm in length
  • Positive indication on KOH Direct Microscopic Inspection on target nail
  • Positive dermatophyte or dermatophyte/candida on Fungi Cultivation Inspection on target nail
  • The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent.

Exclusion Criteria:

  • The subjects suffering other diseases that may cause nail abnormalities or are supposed to be affecting the assessment of the efficacy of study agent by the judgment of investigators
  • The subjects having a case history of hypersensitivity reaction to the component of Jublia® topical solution or Azole derivatives.
  • The pregnant, lactating, or fertile woman free from pertinent contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280927


Locations
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Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT03280927     History of Changes
Other Study ID Numbers: JBL_OM_IV
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-A ST Co., Ltd.:
Onychomycosis
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Efinaconazole
Antifungal Agents
Anti-Infective Agents