Drugs / Amorolfine

Trials 4 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 43 trials
Phase 4 NCT02812043 Aug 2016 → Jun 2019 nail infection Mahidol University Completed No outcome recorded
Phase 4 NCT02705664 Jan → Sep 2016 dermatomycosis Galderma R&D Completed No outcome recorded
Phase 4 NCT02679911 Sep 2015 → Jun 2016 dermatophytosis Galderma R&D Completed No outcome recorded
Phase not applicable1 trial
NCT06689852 Oct 2024 → Jul 2025 overdue tinea unguium Oystershell NV Recruiting No outcome recorded
Also used as a comparator or background therapy in 11 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT01528813 Comparator Feb 2012 → Dec 2013 tinea unguium Brasilia University Hospital Unknown No outcome recorded
Phase 32 trials
Phase 3 NCT02549001 Comparator Aug 2015 → Sep 2018 tinea unguium Polichem S.A. Completed No outcome recorded
Phase 3 NCT00459537 Comparator Mar 2007 → Jan 2009 tinea unguium Novartis Completed No outcome recorded
Phase 42 trials
Phase 4 NCT01851590 Comparator Oct 2013 → Oct 2014 tinea unguium Helsinki University Central Hospital Completed No outcome recorded
Phase 4 NCT01014637 Comparator Aug 2009 → Sep 2011 tinea unguium Pierre Fabre Dermo Cosmetique Unknown No outcome recorded
Phase not applicable6 trials
NCT06254027 Comparator Mar 2024 → Jun 2025 tinea unguium Oystershell NV Unknown No outcome recorded
NCT04961684 Comparator Feb → Sep 2020 fungal infection of the toenail Oystershell NV Completed No outcome recorded
NCT03098342 Comparator Jun 2017 → Dec 2018 fungal infection of the toenail Chulalongkorn University Completed No outcome recorded
NCT03382717 Comparator Oct 2016 → Aug 2017 fungal infection of the toenail Oystershell NV Completed No outcome recorded
NCT03289871 Comparator Jan → Nov 2015 tinea unguium Oystershell NV Completed No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as Amorolfine “The present study was set up to evaluate the efficacy and safety of a water-based, peelable nail polish (daily application), which acidifies the nail environment, versus a 5%...” PMID 30051298 Jul 2018
12

Amorolfine 5% nail lacquer (Loceryl) is a broad-spectrum morpholine antifungal demonstrated 60-75% mycological cure rate in several randomized controlled trials for the...” NCT01929187

“Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days.” NCT04961684

“Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%” NCT02705664

Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot” NCT02679911

“the reference product (Loceryl, 5% amorolfine)” NCT06689852

NCT01851590

NCT03098342

NCT01528813

NCT00459537

NCT02549001

NCT02812043

NCT01014637

Known as Amorolfina ChEMBL registry synonym — accepted as the source's own label CHEMBL489411
Known as Amorolfine (as hydrochloride) ChEMBL registry synonym — accepted as the source's own label CHEMBL489411
Known as amorolfine 5% nail lacquer (Loceryl) amorolfine 5% nail lacquer (Loceryl)NCT01929187
Known as Amorolfine hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL489411
Known as Amorolfine hydrochloride Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot” NCT02679911
1

Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot” NCT02705664

Known as Loceryl “Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days.” NCT04961684
6

“Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%” NCT02705664

“Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.” NCT03098342

“5% Amorolfine Lacquer is applied once weekly for 9 months (Loceryl®) in toenail onychomycosis.” NCT01851590

“the reference product (Loceryl, 5% amorolfine)” NCT06689852

NCT03289871

NCT06254027

Known as Loceryl curanail ChEMBL registry synonym — accepted as the source's own label CHEMBL489411
Known as Omicur ChEMBL registry synonym — accepted as the source's own label CHEMBL489411
Known as RO 14-4767/000 ChEMBL registry synonym — accepted as the source's own label CHEMBL489411
Action Inhibit inhibits the biosynthesis of the fungal cell membrane” NCT02812043
Modality Small molecule “Amorolfine is a morpholine derivative used in topical anti-fungal” NCT02812043
Route Topical “5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.” NCT00459537