Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections

Study Clinical, Multicenter, Phase III, to Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections Like Tinea Foot, Tinea and Tinea Crural Body

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01105013

Acronym

Tonaftato

Enrollment

Registered

2010-04-16

Start date

2012-04-30

Completion date

2012-07-31

Last updated

2012-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal Infections, Tinea Pedis, Tinea Cruris, Tinea Corporis

Keywords

fungal infections, tinea, tonaftato

Brief summary

This is a study clinical, multicenter, Phase III trial, to evaluate the efficacy and safety of tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Detailed description

Study Clinical, multicenter, Phase III, to evaluate the efficacy and safety of 10mg/g tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Interventions

DRUGClotrimazole

Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients of both sexes, of any race, aged 12 years; * Ability to understand and sign the IC (for patients older than age) in the case of minors monitoring and consent of a guardian; * Clinical diagnosis of fungal infections for tinea pedis (ringworm of the feet) or tinea cruris (ringworm of the groin region), or tinea corporis (ringworm in other body areas); * Direct mycological exam positive for fungi;

Exclusion criteria

* Pregnant women or nursing mothers; * Use of topical or oral antifungal; * Use of steroids; * Allergy or hypersensitivity to any component of product; * Clinical cases of tinea infection by bacteria and / or eczema, tinea extensive and onychomycosis.

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g.	97 days	Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.

Countries

Brazil

Contacts

Primary ContactCarlos Machado Filho, investigator

dermatologia@fmabc.br55 11 99018981

Backup ContactMonice Karolis, coordinator

monicekarolis@hotmail.com55 11 97963572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026