Topical Gel Anti-Fungal Agent for Tinea Unguium

Onychomycosis Clinical Trial

Official title:

Phase IIB Efficacy and Safety Study of Four Topical Gel Formulations of Anti-Fungal Agents, MQX-5858, MQX-5859, MQX-5866, and MQX-5867, Versus Vehicle in the Treatment of Tinea Unguium.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253305
• Other study ID #: MQT-05-001
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2005
• Last updated: May 29, 2007
• Start date: September 2005

Study information

• Verified date: May 2007
• Source: MediQuest Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis).

The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety.

Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of distal subungual tinuea unguium of one great toenail.

• between 20 - 65% infected area for target nail

• 2 mm of clear nail proximally on target nail

• positive dermatophyte culture and positive KOH test

• able to sign informed consent

• understand requirements of study

• females must be post-menopausal or agree to use approved contraceptives throughout the study

Exclusion Criteria:

• patients with nails infected with organisms other than dermatophytes

• patients with proximal subungual tinea unguium

• patients with spikes of disease extending to nail matrix

• patients with more than 5 infected nails

• patients with confounding problems/ abnormalities of target nail

• patients with screening lab values more than 20% of normal

• patients with known hypersensitivity to test material components

• patients requiring systemic medications that may interfere with study

• patients with a poor history of compliance with study requirements

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• Organogel of naftifine, 2%

• Organogel of terbinafine, 2%

• Organogel of naftifine, 6%

• Organogel of terbinafine, 6%

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Greater Miami Skin and Laser Center	Miami Beach	Florida
United States	Northwest Cutaneous research	Portland	Oregon
United States	Washington University	St. Louis	Missouri
United States	Genova Clinical Research, Inc.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MediQuest Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quanitative improvement in toenail appearance.
Primary	Assessment of dermatophyte culture and KOH examination.
Primary	Frequency and severity of adverse events.
Secondary	Time to achieve 90% and 100% clearance of fungus from nail.
Secondary	Assessment of treatment success.
Secondary	Assessment of mycological success.