Onychomycosis
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CLINICAL_TRIALS trial_result · 2024-03-05Clinical Trial Update: Human Factors Testing for OTC Use of the Erchonia® LunulaLaser [NA]
This document reports the completion of human factors testing for OTC use of the Erchonia LunulaLaser. The study concerns onychomycosis and …
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CLINICAL_TRIALS trial_result · 2023-08-21Clinical Trial Update: Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial [Phase 4]
A Phase 4 randomized trial comparing combined fractional CO2 laser with topical tioconazole versus Q-switched Nd:YAG laser for treatment of …
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CLINICAL_TRIALS trial_result · 2023-05-10Clinical Trial Update: Diode Laser and Photodynamic Therapy Vs. Ciclopirox. [Phase 4]
Phase 4 clinical trial comparing diode laser and photodynamic therapy against ciclopirox for onychomycosis.
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FDA approval · 2023-04-10FDA Approved: TAVABOROLE — Original Application (Zydus Lifesciences Limited)
FDA approved Tavaborole as a generic product under ANDA212294 from Zydus Lifesciences Limited for the treatment of onychomycosis.
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FDA approval · 2022-03-31FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for JUBLIA (efinaconazole) submitted by Bausch Health US LLC.
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CLINICAL_TRIALS trial_result · 2021-11-22Clinical Trial Update: Efficacy of Intralesional PRP in Treatment of Onychomycosis [Phase 3]
A Phase 3 clinical trial evaluating intralesional platelet-rich plasma for treatment of onychomycosis is described, with the status currentl…
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CLINICAL_TRIALS trial_result · 2021-11-01Clinical Trial Update: Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis [Phase 4]
Phase 4 study evaluating safety and pharmacokinetics of efinaconazole topical solution in patients with mild to severe onychomycosis; result…
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CLINICAL_TRIALS trial_result · 2021-09-28Clinical Trial Update: Topical Amphotericin B in 30% Dimethylsulphoxide in Treating of Non-dermatophytes Onychomycosis [Phase 4]
A Phase 4 trial evaluating topical amphotericin B in 30% dimethylsulphoxide for non-dermatophyte onychomycosis has completed.
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CLINICAL_TRIALS trial_result · 2021-02-17Clinical Trial Update: Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1% [Phase 4]
Phase 4 study comparing Loceryl (amorolfine) nail lacquer 5% to a two-course regimen of urea 40% ointment plus bifonazole cream 1% for treat…
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FDA approval · 2021-02-09FDA Approved: TAVABOROLE — Original Application (Cipla USA Inc.)
The FDA approved Cipla USA Inc.'s original generic application for tavaborole, enabling a generic version of tavaborole topical solution for…
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FDA approval · 2021-02-03FDA Approved: TAVABOROLE — Original Application (Chartwell RX, LLC)
FDA approved Tavaborole as a generic product under an Original Application (ANDA 211963) for Chartwell RX, LLC.
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CLINICAL_TRIALS trial_result · 2020-11-04Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail [Phase 2]
Phase 2 trial evaluating oral VT-1161 for onychomycosis of the toenail has completed with results posted.
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FDA approval · 2020-10-21FDA Approved: TAVABOROLE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approves Tavaborole as a generic product under an Original Application (ANDA) by Alembic Pharmaceuticals Inc., expanding access to treat…
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FDA approval · 2020-10-13FDA Approved: TAVABOROLE — Original Application (Encube Ethicals, Inc.)
ANDA Original Application approved for Tavaborole topical solution 5% by Encube Ethicals, Inc., a generic version of tavaborole for onychomy…
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CLINICAL_TRIALS trial_result · 2020-09-03Clinical Trial Update: A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail [Phase 2]
Phase 2 trial assessing the safety and efficacy of EcoNail for treating fungal infections of the great toenail (onychomycosis) has completed…
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CLINICAL_TRIALS trial_result · 2020-08-25Clinical Trial Update: Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis [Phase 2]
Phase 2 trial update comparing SUBA-Itraconazole with SPORANOX in onychomycosis has completed with results posted.
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FDA approval · 2020-04-26FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for JUBLIA (efinaconazole) submitted by Bausch Health US LLC.
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CLINICAL_TRIALS trial_result · 2020-04-10Clinical Trial Update: Systemic Uptake of Diclofenac Sodium in Combination With Miconazole as Antifungal Nail Gel When Applied Daily With Monitoring of Hepatic and Renal Enzymes, and Serum Levels of Diclofenac 12 Hours After Application, and at 3 and 6 Months Study [Phase 2]
Phase 2 trial evaluating systemic uptake of diclofenac sodium when used in combination with miconazole as an antifungal nail gel, monitoring…
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CLINICAL_TRIALS trial_result · 2019-10-23Clinical Trial Update: Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients [Phase 3]
Phase 3 trial evaluating efficacy and safety of efinaconazole 10% solution for onychomycosis in diabetic patients completed with posted resu…
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CLINICAL_TRIALS trial_result · 2019-10-11Clinical Trial Update: Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail) [NA]
This early feasibility study completed with results posted in 2019 evaluating the RenewalNail Plasma Treatment System for onychomycosis (fun…
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CLINICAL_TRIALS trial_result · 2019-09-24Clinical Trial Update: Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail [Phase 2]
Phase 2 trial update on HTS-519 Insert for onychomycosis (toenail fungus) assessing efficacy, safety, and tolerability.
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CLINICAL_TRIALS trial_result · 2019-08-29Clinical Trial Update: Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail) [NA]
An early feasibility study assessing the efficacy and safety of the RenewalNail Plasma Treatment System for mild to moderate onychomycosis (…
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CLINICAL_TRIALS research · 2019-03-19Clinical Trial Update: Study Evaluating the Effect of Jublia on Dermatophytomas [Phase 4]
Phase 4 trial investigating the effect of Jublia on dermatophytomas in onychomycosis and dermatophytosis.
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CLINICAL_TRIALS trial_result · 2019-02-21Clinical Trial Update: Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I) [Phase 2]
Phase 2 ADME study reporting absorption and systemic exposure of tavaborole (AN2690) in patients with moderate to severe onychomycosis; tria…
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CLINICAL_TRIALS trial_result · 2019-02-20Clinical Trial Update: Clinical Trial of Topical ABL01 Treatment of Onychomycosis [NA]
This document notes the completion of a clinical trial evaluating topical ABL01 for toenail onychomycosis. The sponsor listed is Abbell AB.