Clinical trial NCT00253305: Topical Gel Anti-Fungal Agent for Tinea Unguium
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Keywords: tinea unguium
onychomycosis
Lead sponsor: MediQuest Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quanitative improvement in toenail appearance.
measure: Assessment of dermatophyte culture and KOH examination.
measure: Frequency and severity of adverse events.
Secondary outcomes:
measure: Time to achieve 90% and 100% clearance of fungus from nail.
measure: Assessment of treatment success.
measure: Assessment of mycological success.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: Miami Beach
country: United States
facility: Greater Miami Skin and Laser Center
state: Florida
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Portland
country: United States
facility: Northwest Cutaneous research
state: Oregon
Study officials:
References: