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Luliconazole

Generic Name
Luliconazole
Brand Names
Luzu
Drug Type
Small Molecule
Chemical Formula
C14H9Cl2N3S2
CAS Number
187164-19-8
Unique Ingredient Identifier
RE91AN4S8G
Background

Luliconazole is a topical antifungal agent that acts by unknown mechanisms but is postulated to involve altering the synthesis of fungi cell membranes. It was approved by the FDA (USA) in November 2013 and is marketed under the brand name Luzu. Luliconazole is also approved in Japan.

Indication

Luliconazole is indicated for the treatment of interdigital tinea pedis, tinea cruris, or tinea corporis infections caused by Trichophyton rubrum and Epidermophyton floccosum.

Associated Conditions
Tinea infections of the feet caused by Epidermophyton floccosum, Tinea infections of the feet caused by Trichophyton rubrum

Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis

Phase 4
Completed
Conditions
Tinea Corporis
Interventions
Drug: Vehicle Cream
First Posted Date
2016-05-11
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
75
Registration Number
NCT02767947
Locations
πŸ‡©πŸ‡΄

Valeant Site 01, Santo Domingo, Dominican Republic

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Valeant Site 02, San Pedro Sula, Honduras

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Valeant Site 03, San Cristobal, Dominican Republic

Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

Phase 4
Completed
Conditions
Tinea Cruris
Tinea Pedis
Interventions
First Posted Date
2016-05-10
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
30
Registration Number
NCT02767271
Locations
πŸ‡­πŸ‡³

Valeant Site 02, San Pedro Sula, Honduras

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Valeant Site 01, Santo Domingo, Dominican Republic

Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris

Phase 4
Completed
Conditions
Tinea Cruris
Tinea Pedis
Interventions
First Posted Date
2015-03-20
Last Posted Date
2019-11-27
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
20
Registration Number
NCT02394340
Locations
πŸ‡ΊπŸ‡Έ

TKL Research, Fair Lawn, New Jersey, United States

Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis

Phase 2
Completed
Conditions
Distal and Lateral Subungual Onychomycosis
Interventions
Drug: Vehicle Solution
First Posted Date
2011-09-12
Last Posted Date
2015-11-30
Lead Sponsor
Topica Pharmaceuticals
Target Recruit Count
334
Registration Number
NCT01431820

Topical Antifungal Treatment for Tinea Pedis

Phase 3
Completed
Conditions
Tinea Pedis
Interventions
Drug: Placebo
First Posted Date
2011-07-19
Last Posted Date
2013-08-28
Lead Sponsor
Medicis Global Service Corporation
Target Recruit Count
321
Registration Number
NCT01396785

Topical Antifungal Treatment for Tinea Pedis

Phase 3
Completed
Conditions
Tinea Pedis
Interventions
Drug: Placebo
First Posted Date
2011-07-19
Last Posted Date
2013-08-28
Lead Sponsor
Medicis Global Service Corporation
Target Recruit Count
322
Registration Number
NCT01396811

Topical Antifungal Treatment for Tinea Cruris

Phase 3
Completed
Conditions
Tinea Cruris
Interventions
Drug: Placebo
First Posted Date
2011-04-27
Last Posted Date
2013-08-28
Lead Sponsor
Medicis Global Service Corporation
Target Recruit Count
483
Registration Number
NCT01342315

Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis

Phase 1
Completed
Conditions
Onychomycosis
Interventions
First Posted Date
2010-01-07
Last Posted Date
2014-11-26
Lead Sponsor
Topica Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT01044381
Locations
πŸ‡ΊπŸ‡Έ

J&S Studies, College Station, Texas, United States

Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)

Phase 2
Completed
Conditions
Tinea Pedis
Interventions
Drug: Placebo Comparator -2 wks
Drug: Placebo Comparator - 4 wks
First Posted Date
2009-03-26
Last Posted Date
2011-06-21
Lead Sponsor
Tinea Pharmaceuticals
Target Recruit Count
147
Registration Number
NCT00869336
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