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

Tinea Pedis Clinical Trial

— Tonaftato  

Official title:

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"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01105013
• Other study ID #: TEU-TOL-03/09
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 14, 2010
• Last updated: April 11, 2012
• Start date: April 2012
• Est. completion date: July 2012

Study information

• Verified date: April 2012
• Source: Laboratório Teuto Brasileiro S/A
• Contact: Carlos Machado Filho, investigator
• Phone: 55 11 99018981
• Email: dermatologia[@]fmabc.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Fungal Infections
• Infection
• Mycoses
• Tinea
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Intervention

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

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Laboratório Teuto Brasileiro S/A

Country where clinical trial is conducted

Brazil, 

Outcome

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