MedPath

Amorolfine

Generic Name
Amorolfine
Drug Type
Small Molecule
Chemical Formula
C21H35NO
CAS Number
78613-35-1
Unique Ingredient Identifier
AB0BHP2FH0
Background

Amorolfine or amorolfin, is a morpholine antifungal drug that inhibits the fungal enzymes D14 reductase and D7-D8 isomerase. This inhibition affects fungal sterol synthesis pathways, depleting ergosterol and causing ignosterol to accumulate in the fungal cytoplasmic cell membranes. Amorolfine is marketed as Curanail, Loceryl, Locetar, and Odenil. It is available in the form of a 5% amorolfine nail lacquer used to treat onychomycosis (fungal infection of the toe- and fingernails). Amorolfine 5% nail lacquer in once or twice weekly applications is 60-71% effective in treating toenail onychomycosis; complete cure rates three months after stopping treatment (after six months of treatment) were 38-46%. However, full experimental details of these trials were not available and since they were first reported in 1992 there have been no subsequent trials.

It is a topical solution for the treatment of toenail infections. Systemic treatments may be considered more effective.

It is approved for sale over the counter in Australia and the UK (recently re-classified to over the counter status), and is approved for the treatment of toenail fungus by prescription in other countries. It is not approved for the treatment of onychomycosis in the United States or Canada.

Indication

外用于治疗由皮肤癣菌如红色毛癣菌、须癣毛癣菌、絮状表皮癣菌和犬小孢子菌等所致的浅表皮肤真菌感染,如手癣、足癣(尤其是角化增厚型)、体癣、股癣;亦可用于头癣;也适用于治疗甲真菌病。外用于由念珠菌如白色念珠菌等所致的皮肤念珠菌感染和念珠菌性外阴阴道炎。外用于由马拉色菌属所致的花斑癣。

Associated Conditions
Fungal skin infection, Fungus, Nail, Pityriasis versicolor, Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea inguinalis, Tinea manuum, Cutaneous candidiasis

CLINICAL INVESTIGATION for the EVALUATION of EFFICACY and SAFETY of TWO PRODUCTS for the TREATMENT of ONYCHOMYCOSIS

Not Applicable
Recruiting
Conditions
Onychomycosis
Interventions
Device: Enriched
First Posted Date
2024-11-15
Last Posted Date
2024-11-15
Lead Sponsor
Oystershell NV
Target Recruit Count
88
Registration Number
NCT06689852
Locations
🇫🇷

Eurofins Dermscan Pharmascan, Villeurbanne, France

Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for Onychomycosis Treatment

Not Applicable
Not yet recruiting
Conditions
Onychomycosis
Interventions
Device: Active Cover Light
Device: Forte
First Posted Date
2024-02-12
Last Posted Date
2024-02-12
Lead Sponsor
Oystershell NV
Target Recruit Count
132
Registration Number
NCT06254027

Mycosis Culture Collection From Dermatological Isolated

Active, not recruiting
Conditions
Nail Diseases
Onychomycosis
Resistant Infection
Interventions
First Posted Date
2022-08-01
Last Posted Date
2024-05-08
Lead Sponsor
University of Rome Tor Vergata
Target Recruit Count
200
Registration Number
NCT05482763
Locations
🇮🇹

Tor Vergata Univerisity Hospital, Rome, Italy

Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

Not Applicable
Completed
Conditions
Onychomycosis of Toenail
Interventions
Device: Solver Pen
First Posted Date
2021-07-14
Last Posted Date
2021-07-14
Lead Sponsor
Oystershell NV
Target Recruit Count
76
Registration Number
NCT04961684
Locations
🇹🇳

Pr Doss office, Tunis, Tunisia

Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

Not Applicable
Completed
Conditions
Onychomycosis of Toenail
Interventions
Device: Excilor Forte
First Posted Date
2017-12-26
Last Posted Date
2024-03-15
Lead Sponsor
Oystershell NV
Target Recruit Count
102
Registration Number
NCT03382717
Locations
🇹🇳

Hospital Habib Thameur, Tunis, Tunisia

🇹🇳

Principal instruction military hospital, Tunis, Tunisia

Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis

Not Applicable
Completed
Conditions
Onychomycosis
Interventions
Device: Excilor
First Posted Date
2017-09-21
Last Posted Date
2017-09-21
Lead Sponsor
Oystershell NV
Target Recruit Count
112
Registration Number
NCT03289871
Locations
🇹🇳

Hospital Habib Thameur, Tunis, Tunisia

🇹🇳

Principal instruction military hospital, Tunis, Tunisia

Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment

Not Applicable
Conditions
Onychomycosis of Toenail
Interventions
Procedure: Methylene blue-mediated photodynamic therapy
First Posted Date
2017-03-31
Last Posted Date
2017-03-31
Lead Sponsor
Chulalongkorn University
Target Recruit Count
42
Registration Number
NCT03098342
Locations
🇹🇭

King Chulalongkorn Memorial Hospital, Bangkok, Thailand

Comparison Between Long-pulsed Nd:YAG, Amorolfine and Combination Treatment in Treating Non-dermatophyte Onychomycosis

Phase 4
Completed
Conditions
Non-dermatophyte Onychomycosis
Interventions
First Posted Date
2016-06-23
Last Posted Date
2021-09-28
Lead Sponsor
Mahidol University
Target Recruit Count
60
Registration Number
NCT02812043
Locations
🇹🇭

Department of Dermatology Siriraj Hospital, Bangkoknoi, Bangkok, Thailand

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

Phase 4
Completed
Conditions
Foot Dermatoses
Interventions
First Posted Date
2016-03-10
Last Posted Date
2021-02-17
Lead Sponsor
Galderma R&D
Target Recruit Count
22
Registration Number
NCT02705664
Locations
🇮🇸

Principal Investigator, Reykjavik, Iceland

Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

Phase 4
Completed
Conditions
Foot Dermatoses
Interventions
First Posted Date
2016-02-11
Last Posted Date
2021-03-22
Lead Sponsor
Galderma R&D
Target Recruit Count
20
Registration Number
NCT02679911
© Copyright 2025. All Rights Reserved by MedPath