Naftifine

Generic Name: Naftifine

Brand Names: Naftin

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₁N

CAS Number: 65472-88-0

Unique Ingredient Identifier: 4FB1TON47A

Background: Naftifine is a synthetic, broad spectrum, antifungal agent and allylamine derivative for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum.

Indication: For the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum.

Associated Conditions: Tinea Corporis, Tinea Cruris, Tinea Pedis

Clinical Trials

Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis

Phase 1

Completed

Conditions: Tinea Cruris
Tinea Pedis

Interventions: Drug: Naftin (naftifine hydrochloride) Cream
Drug: UHE-103 Cream

First Posted Date: 2022-05-05

Last Posted Date: 2024-04-10

Lead Sponsor: Therapeutics, Inc.

Target Recruit Count: 42

Registration Number: NCT05363449

Locations: 🇺🇸
Site #4, Houston, Texas, United States
🇺🇸
Site #1, San Diego, California, United States
🇺🇸
Site #5, Thousand Oaks, California, United States

and more 2 locations

Safety and Efficacy of NAFT900 in Children With Tinea Capitis

Phase 2

Withdrawn

Conditions: Tinea Capitis

Interventions: Drug: Vehicle
Drug: Naftifine hydrochloride foam, 3%

First Posted Date: 2016-01-18

Last Posted Date: 2016-09-09

Lead Sponsor: Merz North America, Inc.

Registration Number: NCT02658292

BE Study of Naftifine HCL

Phase 3

Completed

Conditions: Tinea Pedis

Interventions: Drug: Naftin® 2% (Naftifine hydrochloride 2%)
Drug: Placebo
Drug: Naftifine hydrochloride 2%

First Posted Date: 2015-12-17

Last Posted Date: 2017-05-11

Lead Sponsor: Genzum Life Sciences

Target Recruit Count: 693

Registration Number: NCT02633813

Locations: 🇩🇴
Instituto Dermatológico y Cirugía de Piel, Santo Domingo, San Cristóbal, Dominican Republic
🇺🇸
Moore Clinical Research Inc, Brandon, Florida, United States
🇺🇸
Medi Search, Saint Joseph, Missouri, United States

and more 10 locations

An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

Phase 4

Completed

Conditions: Tinea Corporis

Interventions: Drug: Naftin® Cream, 2% (younger pediatric cohort)
Drug: Naftin® Cream, 2% (older pediatric cohort)

First Posted Date: 2015-06-09

Last Posted Date: 2016-10-28

Lead Sponsor: Merz North America, Inc.

Target Recruit Count: 27

Registration Number: NCT02466867

Locations: 🇭🇳
Merz Investigative Site #504001, San Pedro Sula, Honduras
🇺🇸
Merz Investigative Site#001261, College Station, Texas, United States
🇩🇴
Merz Investigative Site#180001, Santo Domingo, Dominican Republic

Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis

Phase 1

Completed

Conditions: Tinea Pedis

Interventions: Drug: Naftin® Gel 2%
Drug: Placebo Topical Gel
Drug: Naftifine Hydrochloride Gel 2%

First Posted Date: 2015-01-09

Last Posted Date: 2018-09-06

Lead Sponsor: Taro Pharmaceuticals USA

Target Recruit Count: 1519

Registration Number: NCT02335255

Pediatric Subjects With Tinea Corporis

Phase 4

Completed

Conditions: Tinea Corporis

Interventions: Drug: Naftin Cream
Drug: Placebo Cream

First Posted Date: 2014-08-28

Last Posted Date: 2016-10-28

Lead Sponsor: Merz North America, Inc.

Target Recruit Count: 230

Registration Number: NCT02227290

Locations: 🇵🇦
Merz Investigative Site#507001, Panama City, Panama
🇵🇷
Merz Investigative Site#001279, Cidra, Puerto Rico
🇺🇸
Merz Investigative Site#001097, Nashville, Tennessee, United States

and more 16 locations

Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis

Phase 1

Completed

Conditions: Tinea Pedis

Interventions: Drug: Placebo Topical Cream
Drug: Naftin® (Naftifine Hydrochloride) Cream 2%
Drug: Naftifine Hydrochloride Cream 2%

First Posted Date: 2014-05-07

Last Posted Date: 2017-05-09

Lead Sponsor: Taro Pharmaceuticals USA

Target Recruit Count: 890

Registration Number: NCT02132260

Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris

Phase 3

Completed

Conditions: Jock Itch
Tinea Cruris

Interventions: Drug: Naftin 1% Cream
Drug: Placebo Cream

First Posted Date: 2013-06-24

Last Posted Date: 2015-04-15

Lead Sponsor: Merz North America, Inc.

Target Recruit Count: 65

Registration Number: NCT01885156

Locations: 🇧🇿
Merz Investigational Site # 501001, Belize City, Belize
🇧🇿
Merz Investigational Site # 501002, Belize City, Belize
🇩🇴
Merz Investigative Site # 180001, Santo Domingo, Dominican Republic

and more 2 locations

Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis

Phase 1

Completed

Conditions: Tinea Pedis

Interventions: Drug: Naftifine HCl Cream 1%
Drug: Naftin® (Naftifine HCl) Cream 1%
Drug: Placebo topical cream

First Posted Date: 2012-04-19

Last Posted Date: 2014-05-06

Lead Sponsor: Taro Pharmaceuticals USA

Target Recruit Count: 1053

Registration Number: NCT01580891

Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis

Phase 3

Completed

Conditions: Tinea Pedis
Athlete's Foot

Interventions: Drug: NAFT-500
Drug: Placebo 2-weeks
Drug: Naftin 1%
Drug: Placebo 4-weeks

First Posted Date: 2008-09-10

Last Posted Date: 2013-04-26

Lead Sponsor: Merz North America, Inc.

Target Recruit Count: 707

Registration Number: NCT00750139

Locations: 🇺🇸
Research Across America, Plano, Texas, United States
🇺🇸
Silverton Skin Institute, Grand Blanc, Michigan, United States
🇺🇸
Glazer Dermatology, Buffalo Grove, Illinois, United States

and more 12 locations

Drug Development Updates

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