Mild to Moderate Onychomycosis Due to DermatophytePhase 4NCT03280927
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
A Phase 4 study testing Jublia® in people with Mild to Moderate Onychomycosis Due to Dermatophyte, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mild to Moderate Onychomycosis Due to Dermatophyte
- What is being tested?
- Jublia®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Nov 2017to 22 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Jublia®
- Keywords
- Onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jublia®Drug
Jublia® topical solution
| Study group | Role | What they receive |
|---|---|---|
| Jublia® | Experimental | Not described Receives: Drug: Jublia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completely cured subjects
The ratio of completely cured subjects
Measured: 52 weeks
Secondary outcomes (3)
Complete or almost complete cure rates
The ratio of subjects showing less than 5% of infection area
Measured: 52 weeks
Mycologic cure rates
Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection.
Measured: 52 weeks
Clinical efficacy rates
The ratio of subjects affected target nail area less than 10%
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start10 Nov 2017
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Onychomycosis Due to DermatophyteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280927
- Sponsor's protocol ID
- JBL_OM_IV
- Status last verified
- Apr 2021
- First submitted
- 11 Sep 2017
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03280927
- Acronym / sponsor ID
- JBL_OM_IV
- Keywords
- Onychomycosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jublia® | Experimental | Drug: Jublia® |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jublia®Jublia® topical solution | Drug | Jublia® |
Primary outcome
Completely cured subjects
Time frame: 52 weeks
The ratio of completely cured subjects
3 secondary outcomes
Complete or almost complete cure rates
Time frame: 52 weeks
Mycologic cure rates
Time frame: 52 weeks
Clinical efficacy rates
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jublia® in people with Mild to Moderate Onychomycosis Due to Dermatophyte, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completely cured subjects (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.