Topical Gel Anti-Fungal Agent for Tinea Unguium

MediQuest Therapeutics

Status and phase: Completed; Phase 2

Conditions: Onychomycosis

Treatments: Drug: Organogel of terbinafine, 2%; Drug: Organogel of naftifine, 6%; Drug: Organogel of naftifine, 2%; Drug: Organogel of terbinafine, 6%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00253305

MQT-05-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind