Onychomycosis
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CLINICAL_TRIALS trial_result · 2014-08-15Clinical Trial Update: Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail [Phase 3]
Pfizer-sponsored Phase 3 trial evaluating the efficacy and safety of AN2690 topical solution (tavaborole) for toenail onychomycosis has comp…
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CLINICAL_TRIALS trial_result · 2014-08-15Clinical Trial Update: Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail [Phase 2]
Phase 2 clinical trial update on safety and efficacy for treating onychomycosis of the great toenail; results posted in 2014.
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FDA approval · 2014-06-06FDA Approved: JUBLIA — Original Application (Bausch Health US LLC)
FDA approved JUBLIA (efinaconazole) under an original application for the topical treatment of onychomycosis of the toenails. The product is…
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FDA approval · 2014-01-09FDA Approved: ULTRAMICROSIZE GRISEOFULVIN — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved Ultramicrosize Griseofulvin tablets from Amneal Pharmaceuticals of New York LLC via an Original Application.
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CLINICAL_TRIALS trial_result · 2013-12-17Clinical Trial Update: Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients [Phase 1]
This Phase 1 pharmacokinetics and safety study evaluated ME1111 in patients with moderate-to-severe onychomycosis and has been completed.
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CLINICAL_TRIALS research · 2013-08-27Clinical Trial Update: A Randomized Study to Evaluate the Efficacy of Herbal Ingredients Combined With a Carrier System (Phytonail) Compared With Amorolfine 5% Nail Lacquer (Loceryl) in the Treatment of Toenail Onychomycosis [NA]
A randomized study compares a herbal-based carrier system (Phytonail) with Amorolfine 5% nail lacquer (Loceryl) for the treatment of toenail…
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CLINICAL_TRIALS trial_result · 2013-08-07Clinical Trial Update: Erbium-doped Yttrium Aluminium Garnet Laser(Er:Yag)Associated With Amorolfine Lacquer in the Treatment of Onychomycosis [Phase 2]
A Phase 2 clinical trial evaluating the combination of an Er:YAG laser with amorolfine lacquer for the treatment of onychomycosis; the curre…
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CLINICAL_TRIALS trial_result · 2013-07-11Clinical Trial Update: Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails [Phase 3]
A Phase 3 trial of NAB001 for mild-to-moderate toenail onychomycosis has been terminated.
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CLINICAL_TRIALS trial_result · 2013-07-11Clinical Trial Update: Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails [Phase 3]
Phase 3 trial of NAB001 for mild-to-moderate toenail onychomycosis has been terminated. The update references safety and efficacy data but p…
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CLINICAL_TRIALS trial_result · 2013-06-26Clinical Trial Update: A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis [NA]
Completed clinical trial evaluating the early visible effects of K101 applied for 8 weeks on nails affected by onychomycosis.
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CLINICAL_TRIALS trial_result · 2013-06-14Clinical Trial Update: Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules [Phase 4]
Phase 4 trial evaluating a clinical scoring index for toenail onychomycosis in patients treated with itraconazole capsules; results were pos…
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CLINICAL_TRIALS trial_result · 2013-06-11Clinical Trial Update: Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste [Phase 3]
Phase 3 trial comparing bifonazole cream to placebo after nail ablation with urea paste in onychomycosis has completed and reports comparati…
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CLINICAL_TRIALS trial_result · 2013-05-23Clinical Trial Update: Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail [Phase 2]
Phase 2 clinical trial update for treatment of distal subungual onychomycosis of the toenail; the study status is reported as completed.
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FDA approval · 2013-05-21FDA Approved: CICLOPIROX OLAMINE — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Ciclopirox Olamine from Cosette Pharmaceuticals, resulting in updated labeling for its topical a…
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CLINICAL_TRIALS trial_result · 2013-04-09Clinical Trial Update: PinPointe FootLaser for the Treatment of Onychomycosis [Phase 2, Phase 3]
Phase 2/3 trials of PinPointe FootLaser for treating onychomycosis (infected toenails) completed with results posted in 2013.
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CLINICAL_TRIALS trial_result · 2013-02-13Clinical Trial Update: TDT 067 Open Label Multi-Dose Onychomycosis Study [Phase 2]
Phase 2 open-label multi-dose study of TDT 067 for onychomycosis has been completed.
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FDA approval · 2013-02-05FDA Approved: TERBINAFINE — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for terbinafine hydrochloride products from NorthStar Rx LLC. This action confirms continued ava…
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CLINICAL_TRIALS trial_result · 2012-10-25Clinical Trial Update: Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis [Phase 2]
Phase 2 clinical trial evaluating the efficacy and safety of two topical MOB015 regimens in adults with distal subungual onychomycosis.
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FDA approval · 2012-10-22FDA Approved: ULTRAMICROSIZE GRISEOFULVIN — Original Application (Sigmapharm Laboratories, LLC)
FDA approved the original application (ANDA) for ULTRAMICROSIZE GRISEOFULVIN from Sigmapharm Laboratories, LLC.
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CLINICAL_TRIALS trial_result · 2012-10-19Clinical Trial Update: Deposition of Terbinafine After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail [Phase 2]
Phase 2 trial update on deposition of terbinafine after iontophoretic application of ETS terbinafine gel in distal subungual onychomycosis o…
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CLINICAL_TRIALS trial_result · 2012-10-19Clinical Trial Update: Efficacy and Safety Study of Iontophoretic Application of Terbinafine Gel in Subjects With Onychomycosis [Phase 2]
A Phase 2 study evaluating the efficacy and safety of iontophoretic terbinafine gel in subjects with onychomycosis has completed.
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CLINICAL_TRIALS trial_result · 2012-08-01Clinical Trial Update: TDT 067 Onychomycosis Study [Phase 3]
Phase 3 clinical trial update for TDT 067 in onychomycosis; current status is unknown.
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FDA approval · 2012-06-28FDA Approved: TERBINAFINE HYDROCHLORIDE — Supplemental Application (Dr.Reddys Laboratories Limited)
FDA approved a supplemental application for terbinafine hydrochloride tablets (250 mg) from Dr. Reddy's Laboratories Limited, authorizing a …
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CLINICAL_TRIALS trial_result · 2012-06-22Clinical Trial Update: The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis [Phase 3]
A completed Phase 3 trial evaluated the safety and efficacy of topical IDP-108 compared with vehicle for onychomycosis.
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CLINICAL_TRIALS trial_result · 2012-06-22Clinical Trial Update: Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis [Phase 3]
A Phase 3 trial comparing topical IDP-108 to vehicle evaluated safety and efficacy in patients with onychomycosis. The study status is compl…