A Phase 4 interventional study of Jublia® in Mild to Moderate Onychomycosis Due to Dermatophyte, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by Dong-A ST Co., Ltd. · Phase 4, Interventional, and Treatment
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.
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.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's enrollment of 97 is above the median of 60 across 143 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.
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The subjects diagnosed with onychomycosis in up to 6 toenails at least
1 great toenail woth no fingernails
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Jublia®
Jublia® topical solution
Completely cured subjects
The ratio of completely cured subjects
Time frame: 52 weeks
Complete or almost complete cure rates
The ratio of subjects showing less than 5% of infection area
Time frame: 52 weeks
Mycologic cure rates
Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection.
Time frame: 52 weeks
Clinical efficacy rates
The ratio of subjects affected target nail area less than 10%
Time frame: 52 weeks
Ran from Nov 2017 to primary completion in Jan 2020, 26 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Efinaconazole