Onychomycosis
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CLINICAL_TRIALS trial_result · 2016-08-19Clinical Trial Update: Pulsed Dye Laser Treatment of Onychomycosis [NA]
A completed clinical trial evaluated pulsed dye laser treatment for onychomycosis.
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CLINICAL_TRIALS trial_result · 2016-07-21Clinical Trial Update: A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis [NA]
A completed retrospective study assessing the effects of low level laser therapy on toenail onychomycosis. Results were posted in 2016.
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CLINICAL_TRIALS trial_result · 2016-06-17Clinical Trial Update: A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment [Phase 4]
Phase 4 pilot study assessing the safety and efficacy of Nailprotex for onychomycosis (and chronic paronychia) has been completed.
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CLINICAL_TRIALS trial_result · 2016-05-30Clinical Trial Update: Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser [NA]
This document summarizes a completed clinical trial evaluating a 0.65-millisecond pulsed Nd:YAG 1064 nm laser for treating onychomycosis, wi…
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FDA approval · 2016-04-01FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
FDA approves a supplemental application for JUBLIA (efinaconazole) from Bausch Health US LLC, potentially updating labeling or adding new in…
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CLINICAL_TRIALS trial_result · 2016-01-27Clinical Trial Update: Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus [NA]
A completed efficacy study of LIQUICURE for onychomycosis (toe nail fungus).
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CLINICAL_TRIALS trial_result · 2015-12-11Clinical Trial Update: Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus [NA]
A completed clinical trial evaluated low level laser light therapy for onychomycosis (toenail fungus); results were posted in 2015.
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CLINICAL_TRIALS trial_result · 2015-11-30Clinical Trial Update: Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis [Phase 2, Phase 3]
Clinical trial update reports safety and efficacy of luliconazole 10% solution for mild-to-moderate onychomycosis in Phase 2/3, with the stu…
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CLINICAL_TRIALS trial_result · 2015-11-30Clinical Trial Update: Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis [Phase 4]
Phase 4 trial comparing resin, amorolfine, and terbinafine for onychomycosis; the study has completed and results were posted in 2015.
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FDA approval · 2015-11-05FDA 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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FDA approval · 2015-10-30FDA Approved: ITRACONAZOLE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's original ANDA for itraconazole, enabling a generic version of the antifungal agent to be marketed.
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FDA approval · 2015-10-14FDA Approved: CICLOPIROX — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved a supplemental application for Ciclopirox from Padagis Israel Pharmaceuticals Ltd, indicating an update to the product's labeli…
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FDA approval · 2015-10-08FDA Approved: CICLOPIROX — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Ciclopirox from Sun Pharmaceutical Industries, Inc., under the ANDA framework. The approval indi…
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CLINICAL_TRIALS trial_result · 2015-09-10Clinical Trial Update: Prevalence and Clinical Characteristics of the Fungal Nail and Feet Infection in Patients With Hallux Valgus
This clinical trial update describes the prevalence and clinical characteristics of fungal nail infections and other foot infections in pati…
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FDA approval · 2015-08-26FDA 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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FDA approval · 2015-08-25FDA Approved: TERBINAFINE — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for terbinafine hydrochloride (NorthStar Rx LLC). This action updates labeling/indications for the p…
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CLINICAL_TRIALS trial_result · 2015-08-10Clinical Trial Update: Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus [NA]
The study evaluated Erchonia's low-level laser light therapy for toenail fungus (onychomycosis); the trial is completed and results were pos…
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CLINICAL_TRIALS trial_result · 2015-06-04Clinical Trial Update: Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail [Phase 2]
Phase 2 safety and efficacy study of HTU-520 for distal subungual onychomycosis of the toenail has completed.
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CLINICAL_TRIALS trial_result · 2015-05-15Clinical Trial Update: Chart Review of the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
Completed chart-review study evaluating the efficacy of the GenesisPlus 1064 nm Nd:YAG laser for treating onychomycosis.
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CLINICAL_TRIALS trial_result · 2015-05-06Clinical Trial Update: Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis [Phase 4]
This document provides a Phase 4 clinical trial update evaluating the efficacy of CURE-EX for the treatment of onychomycosis.
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FDA approval · 2015-02-27FDA 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 · 2015-01-13Clinical Trial Update: A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail [NA]
A clinical trial evaluating a toenail treatment kit for onychomycosis has completed; no trial results are provided in the available informat…
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FDA approval · 2014-12-01FDA Approved: CICLOPIROX — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for Ciclopirox from Glenmark Pharmaceuticals Inc., USA.
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CLINICAL_TRIALS trial_result · 2014-11-26Clinical Trial Update: Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis [Phase 1, Phase 2]
Open-label PK and safety study of luliconazole 10% solution for distal subungual onychomycosis has completed Phase 1 and Phase 2.
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CLINICAL_TRIALS trial_result · 2014-10-21Clinical Trial Update: Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens
A completed clinical trial evaluated a DNA oligonucleotide array for rapid identification of dermatophyte species in clinical specimens.