Onychomycosis
Conditions
Keywords
tinea unguium, onychomycosis
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.
Interventions
DRUGOrganogel of naftifine, 2%
DRUGOrganogel of terbinafine, 2%
DRUGOrganogel of naftifine, 6%
DRUGOrganogel of terbinafine, 6%
Sponsors
MediQuest Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quanitative improvement in toenail appearance. | — |
| Assessment of dermatophyte culture and KOH examination. | — |
| Frequency and severity of adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve 90% and 100% clearance of fungus from nail. | — |
| Assessment of treatment success. | — |
| Assessment of mycological success. | — |
Countries
United States
Outcome results
None listed