Onychomycosis Clinical Trial
Official title:
A Study of Skin/Nail Sensation and the Pharmacokinetics of the Uptake of Terbinafine in the Great Toe Nail and Systemically Following Treatment With the Electrokinetic Transungual System (ETS)-Terbinafine Gel in Healthy Normal Voluneteers
Terbinafine is recognized as one of the most effective drugs for the treatment of toe nail
fungus (onychomycosis). This trial will be the first test of a new device to improve the
delivery of terbinafine directly to the toe nail. The device uses a low level of electric
current, iontophoresis, to "push" the terbinafine into the nail.
The study will involve a single application of terbinafine, in a gel form, with the
iontophoretic device. The treatment will be applied to the surface of both large toenails of
healthy subjects. Subjects will be asked to report any sensations in the nail or surrounding
skin experienced during or after treatment. Samples from the edge of the treated toe nail
will be taken at 2-4 week intervals to measure how much terbinafine was delivered to the
nails, and blood samples will be taken for the first 24 hours after treatment to determine
how much, if any, terbinafine was absorbed into the subjects's body. Observations will also
be made of the treated toes to look for any irritation of the surrounding skin due to the
treatment.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03098615 -
Study Evaluating the Effect of Jublia on Dermatophytomas
|
Phase 4 | |
| Recruiting |
NCT01666002 -
Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
|
N/A | |
| Completed |
NCT01180491 -
A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
|
N/A | |
| Terminated |
NCT01208168 -
Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
|
Phase 3 | |
| Terminated |
NCT01208129 -
Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
|
Phase 3 | |
| Completed |
NCT00385502 -
A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail
|
Phase 2 | |
| Completed |
NCT00253305 -
Topical Gel Anti-Fungal Agent for Tinea Unguium
|
Phase 2 | |
| Not yet recruiting |
NCT05809297 -
Diode Laser and Photodynamic Therapy Vs. Ciclopirox.
|
Phase 4 | |
| Completed |
NCT03405818 -
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
|
Phase 4 | |
| Completed |
NCT02588599 -
A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis
|
N/A | |
| Recruiting |
NCT02436291 -
Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
|
Phase 4 | |
| Completed |
NCT01851590 -
Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
|
Phase 4 | |
| Completed |
NCT01452490 -
Diode Laser Treatment of Onychomycosis
|
N/A | |
| Withdrawn |
NCT00938925 -
Effectiveness of Podiatry Care on Onychomycosis (EPOCAON)
|
N/A | |
| Recruiting |
NCT00808366 -
Efficacy and Safety of RV4104A Ointment in Onychomycosis
|
N/A | |
| Completed |
NCT00781820 -
Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste
|
Phase 3 | |
| Completed |
NCT00777868 -
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
|
Phase 2 | |
| Recruiting |
NCT06074315 -
Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
|
N/A | |
| Completed |
NCT01039883 -
A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule
|
Phase 1 | |
| Suspended |
NCT05491603 -
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
|
Phase 2 |